AdvaMed 510(k) Submissions Workshop: How to Assemble A Bullet Proof 510(k) Submission for the FDA

Important Notice: The information provided in this course represents the personal opinions of the instructors and does not necessarily
represent the opinions of AdvaMed staff or that of Fang Consulting. Companies relying on the information do so at their own risk and
assume the risk of any subsequent liability that results from relying on the information. The information does not constitute legal advice.
AdvaMed 510(k) Submissions Workshop
October15,2018
1:30 – 3:00 pm, 3:15 – 4:45 pm
Presented by: Jonathan Lendrum
https://fangconsulting.com/
How to Assemble a 510(k) Submission for the FDA
Providing Regulatory Affairs, Clinical Affairs, & Quality Systems Consulting Since 1999

2https://fangconsulting.com/
Learning Objectives
1. To understand how to selecta predicate device for your 510(k) submission
2. To understand how to collectand organize the data and actually prepare the 510(k)
3. To understand FDAForm 3654:Standards Data Report
4. To understand 510(k) tips and bestpractices,potential pitfalls and commonmistakes

Learning Objectives
What is a medicalDevice?
Section201(h) of the Federal,Food,Drug and Cosmetic Act(FD&C Act)and 21 USC 321(h):
the term “device” means an instrument, apparatus, implement,machine, contrivance, implant, in
vitro reagent, or other similar or related article, including any component,part, or accessory,which
is:
1. Intendedfor use in the diagnosis of disease or other conditions,or in the cure, mitigation,
treatment, or prevention of disease,in man or other animals, or
2. Intendedto affect the structure or any function of the body of man or other animals, and which
does not achieve its primaryintended purposes throughchemicalaction within or on the body
of man or other animals and which is not dependentupon being metabolized for the
achievement of its primary intended purposes
Define Intended:have (a course of action) as one’s purpose,aim, or objective;plan that (something)
functions in a particular way; to premeditate a deliberate action plan for a particular purpose,goal, or end
Define Use: to take, hold, or deploy(something)to accomplisha purpose or achieve a result
“The road to hell is paved with good intentions”

How to get your medical device onto the U.S. market
Step One: ClassifyYour Device
Class I – LowestRisk – Subjectto General Controls – With and Without Exemptions
Class II – Moderate Risk – Subject to General and SpecialControls – With and Without Exemptions
Class III – Highest Risk –
Step Two: Chose the CorrectPremarket Regulatory Pathway/Submission
Exempt(typically Class I)
Premarket Notification (510(k), typically Class II)
PremarketApproval (PMA, typically Class III)
Step Three:Chose Your Predicate Device(s)and Prepare Appropriate Informationforyour 510(k) sub
Step Four: Send Your Premarket Notification Submissionto the FDAfor Review
User Fees:MDUFA
eCopy:Must provide and electronic copy
Administrative Filing Review: Refuse to AcceptPolicyfor 510(k)s
Interactive Review:
Step Five: Receive Clearance Letter and Complete EstablishmentRegistrationand Device Listing
Medical Device Market Authorization

Class Risk
Risk Control Measures
# of Device
Types
Device ExamplesGeneral
Controls
Special
Controls
Premarket
Approval
(PMA)
I Low x N/A N/A ~780
Band-Aids, Dental Floss,
Examination Gloves, Hand-
Held Surgical Instruments
II Medium x x N/A ~800
Infusion Pumps, Syringes,
Needles, Blood Pressure
Cuffs
III High x x x ~120
Brain/Spinal Stimulators,
Pacemakers, Heart Valves,
Breast Implants,
Ventilators
21 CFR Part 860.130;Section513(a)(1)of the FD&C Act;21 U.S.C. 360c(a)(1)
The FDA has established classifications forapproximately 1,700 differentgeneric typesof devices and
groupedthem into 16 medicalspecialties referred to as panels. These panels are found in Parts 862
through 892 in the CFR. Each of these generic types of devices is assigned to one of three regulatory
classesbasedon the levelof controlnecessaryto assurethe safety and effectivenessof the
device.The three classes and the requirements which apply to them are:
Medical Device Risk-Based Classes
Fewer control
measures
More controls
measures

Panel Medical Specialty Panel Regulation
73 Anesthesiology 21 CFR 868
74 Cardiovascular 21 CFR 870
75 Chemistry 21 CFR 862
76 Dental 21 CFR 872
77 Ear, Nose,and Throat 21 CFR 874
78 Gastroenterologyand Urology 21 CFR 876
79 General and Plastic Surgery 21 CFR 878
80 General Hospital 21 CFR 880
81 Hematology 21 CFR 864
82 Immunology 21 CFR 866
83 Microbiology 21 CFR 866
84 Neurology 21 CFR 882
85 Obstetrical and Gynecological 21 CFR 884
86 Ophthalmic 21 CFR 886
87 Orthopedic 21 CFR 888
88 Pathology 21 CFR 864
89 Physical Medicine 21 CFR 890
90 Radiology 21 CFR 892
91 Toxicology 21 CFR 862
21 CFR Part 860.130;Section513(a)(1)of the FD&C Act;21 U.S.C. 360c(a)(1)
FDA Requirements Regulations
Establishment Registration (FURLS) 21 CFR Part 807
Medical Device Listing 21 CFR Part 807
Export Certificates and Notification* 21 CFR Part 801
Premarket Notification 510(k)
Premarket Approval
21 CFR Part 807
Quality System Regulations
• Design/Doc Controls
• CAPA
• Device Master Record
• Purchasing Controls
• UDI Traceability
• Labeling/Packaging
• Handling, Storage, Install
• Servicing
• Statistical Techniques
21 CFR 820
Labeling Requirements 21 CFR Part 801
Postmarket Surveillance 21 CFR Part 803
Classification Medical Specialty Panels, Premarket Regulatory Pathways

GeneralControls 21 CFR 860.3(c)(1)
• EstablishmentRegistration (21 CFR 807)
• Medical Device Listing (21 CFR 807)
• Quality System Regulation (21 CFR 820)
• Labeling (21 CFR 801)
• Medical Device Reporting (21 CFR 803)
SpecialControls 21 CFR 860.3(c)(2)
• SpecialLabeling Requirements
• Mandatory Performance Standards
• PostmarketSurveillance
• Guidance Documents /Agency Comments
• Patient Registries
ProductCodes: Three-lettercodes usedby
FDAto identify and track similar medical
devices;Used by 510(k) submitters to (i) classify
devices;(ii) to determine regulatory
requirements;(iii) and search for predicate
devicesforwhich they will demonstrate
substantialequivalence.
• 80 FRN: Pump, Infusion (Class II)
Your Device Class Determines The Applicable Regulatory Pathway
General Hospital (Medical Specialty Panel)
U.S. Regulatory Pathways for Class I, Class II, and Class III Devices

Guidance –MedicalDevice Classification ProductCodes:
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm285317.htm
PremarketNotification 510(k): is a premarketing submissionmade to FDA to demonstrate that the Class
II (typically) medical device to be marketed is reasonably safe and effective by proving substantial
equivalence(SE) to a legally marketeddevice(predicate device) that is not subjectto Premarket
Approval (PMA, Class III)
SubstantialEquivalence:Demonstrationthat a new device,as compared to a predicate device,has the
same intendeduse and the same technologicalcharacteristics,or differencesin technologydo not
raise differentquestions regarding safety and effectiveness.
Predicate Device:Alegally marketed device (usually Class II), previously cleared through the 510(k)
process(or a preamendment “grandfathered”device),that is used for comparison to a new devicefor the
purposeof determiningsubstantialequivalence
Choosing Your Predicate Device
All predicates are not legally marketed devices, but all legally marketed devices can be predicates
ProductCodes: Classificationproductcodes are a method of internally classifying and tracking
medicaldevices.CDRH and a subsetof CBER regulated medicaldevice product codesconsist
of a 3 letter combination which associates a device’s type with a product class designated forthe
application. Classificationproductcodes and information associated with these devices,such as
names and attributes, are assigned by CDRH to supporttheir regulation.
Classificationproductcodes are also used throughout the total productlife cycle (TPLC)as they
connectall medicaldevice databases!!!(Or try to)

Classifying Your Medical Device
1. Find a legally marked device that is as similar to yours as possiblewith respectto:
- Intended Use
- Technology
2. Use FDA databases to locate potential productcodes with same intended use/technology
- Names of similar devices – trade / commonname under which the device is marketed
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
- Manufacturer(s) of the similar devices (registration and listing database)
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
- ClassificationInfo (i.e. Class II ProCodes,Class-ProCode-Specific Regs ForYour Device)
3. Use productcodes to identify and locate:
- Your Device Classification
- Type of Premarket SubmissionApplicable (510k/PMA/Exempt)
- Potential Predicate Devices (Same ProCode)and CompetitorInformation(510k#)
- Applicable Regulatory Requirements (General/SpecialControls,3rd Party Rev. Eligibility, etc.)
- FDA Guidance Documents (Generaland Device-Specific)
- FDA RecognizedStandards
Once you’ve classifiedyourdevice (Class II), identifiedthe correctregulatory pathway (510k),and chosen
appropriate predicate device(s)for your substantial equivalencecomparison – You’re aboutready to begin
assemblingyour510(k)Submission!
But first…let’s take a closerlook at predicate device selection

510(k) Substantial Equivalence and Predicate Device Selection
Primary Predicate: the identified predicate with indications
and technologymost similar to the subject device when
multiple predicates are identified
Multiple Predicates: This IS ALLOWED
• Option 1: Two predicates with differenttechnology
but the same intended use
• Option 2: A device with more than one intended use
• Option 3: More than one indication under the same
intended use
Split Predicate: This is NOT ALLOWED
• 1st
Predicate has same intended use
• 2nd
Predicate has same technology
ReferenceDevice:a legally marketed device intended to
provide scientific information to supportsafety and
effectiveness.Reference devices are not predicates and
cannot be used to supportSE decisionpoints 1-4.

Predicate Device Case Study: Example 1
Predicate Selection for Substantial Equivalence
• TopicalSkin Adhesive
• Specialcontrols guidance
• Multiple predicates to choose within the MPN productcode
• http://medicaldeviceacademy.com/510k-submission-fda-case-study/

Predicate Selection for Substantial Equivalence
Predicate Device Case Study: Example 2
Pedicle ScrewSpinal System,AdolescentIdiopathic Scoliosis
• Specific Labeling Requirements
• 90 predicatesto choose within the OSH product code, but most people only find 3!
• http://medicaldeviceacademy.com/indications-for-use-case-study/

13
Leaning Objective 1: How to select a predicate device for your 510(k) submission
Predicate Device Selection Examples
• Example 1: Hemodialysis catheter
-Predicate A has same extension design
-Predicate B has same tip design
-Both A&B Predicates have the same intended use
• Example 2: Facture fixation plate
-Predicate A is indicated for middle bone fractures
-Predicate B is indicated for bone tip fractures
-Both A & B predicates are intended for long bone fractures
-New performancetesting may be required
• Example 3: Laser hand piece
-Predicate A Er:YAG laser hand piece
-Predicate B Q-Switch Nd:YAG laser hand piece
-Both A & B predicates have the same general intended use of lasers: “incision, excision,
ablation, vaporization of softtissue.”
-New performancetesting may be required
-A single predicate could have been used, but the inclusion of a second predicate is helpful in
establishing substantial equivalence with regard to specificindications and technological
characteristics.
• Example 4: Multi-parameter monitor
-New monitor includes different technologies
-Predicate for each parameter
-Monitoring of each parameter cannot interfere with the others
-New performance testing may be required
• Example 5: Temperature measuring urinary catheter
-Urinary catheter is primary predicate
-Thermometer is secondary predicate added as a convenience
-Two predicates fall under different classifications
-The additional feature cannot alter the risk profile of the urinary catheter

Predicate Device Due Diligence Strategic Considerations
1. Is it Legally Marketed?History of AdverseEvents? Recalls? Warning Letters?
• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm
• https://www.fda.gov/aboutfda/centersoffices/officeofglobalregulatoryoperationsandpolicy/ora/oraelectronicrea
dingroom/default.htm
• https://www.accessdata.fda.gov/scripts/inspsearch/
• https://www.accessdata.fda.gov/scripts/ires/index.cfm#tabNav_advancedSearch
• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
• https://www.fda.gov/Safety/Recalls/default.htm
2. How much public informationis available for me?Is the device listed?
• PubMed,Medline Plus,NIH, ClinicalTrials.gov,ProductRegistries
3. Are the data/methodsof evaluating differenttechnology risksacceptablefor my SE discussion?
• SE Data: (i) intended use (ii) technology (iii) performance data
4. Scope ofIntended Use / Indications For Use
• Eventually you’ll want to make a second generation product, expand indication for use to other parts of the body, etc.
• You want to start with a predicate with the most broad indications for use. You can always claim a more narrow
indication for use in the SE discussion.
5. Version1.0,2.0, 3.0
• Establish History of Company with FDA
• Many Small Leaps of Logic vs One Big Leap
• Clinical Studies in Parallel with 1st Submission
• Earlier Cash Flow

510(k) Substantial Equivalence and Predicate Device Selection
What do I do if I can’t find a predicate?
• ClinicalStudy & PMA($250,000)
• De Novo Submission
- You have a low or moderate risk device with no identifiable predicate device?
- Kind of a complexprocess
• 510(k)Submission(With ClinicalData)
• Pre-Sub Meeting
- Method to obtain FDAfeedbackprior to submissionof your 510(k); typically forunique situations
(e.g. need for clinical data). Submit a formal written requestto the FDA.Requesteither a formal
written response,meeting,or teleconferenceto address their concerns,questions,etc.
• 513(g)Requestfor Information
FDAand Industry ProceduresforSection513(g)Requests forInformationunder the FD&C Act:
User Fees for 513(g)RequestsforInformation:

510(k) Content
A 510(k)is…
− An application to market/sell your device
− 510(k) applications are “cleared” by FDA
− Also known as a Premarket Notification
− Used to demonstrate Substantial Equivalence
What is a 510(k)SubmissionExactly?
A 510(k)is not…
− An FDAform
− EstablishmentRegistration
− Device Listing or PremarketApproval(PMA)
− An IDE,HDE, STED,Tech File, etc.
When is a 510(k)Required?
• Introducing a Class II device into commercialdistribution forthe first time after May 28, 1976
• Proposing a different intended use for a device which you already have in commercial distribution
- Please note that a new 510(k) is required to change from Rx use to OTC (expanding indications)
• A significant change or modificationaffecting the device safety or effectiveness.
Who is subjectto 510(k)Requirements?
• Domestic Manufacturers
• The SpecificationDeveloper
• Repackagers and Relabelers
• ForeignManufacturers/Exporters

510(k) Content
InformationRequiredin a 510(k)Submission (21 CFR 807.87)
• The device name, including both the trade or proprietary name and the commonor usual name or
classificationname of the device
• The establishmentregistration number, if applicable
• The class and, if known, its appropriate panel [e.g., Dental (76)]
• Action taken forperformance standards
• Proposed labels,labeling, and advertisements sufficientto describethe device,its intended use, and
the directions for use. Where applicable,photographs or engineering drawings should be supplied.
• A statementindicating the device is similar to and/or differentfrom other products of comparable type
in commercialdistribution (an identification of similar products,materials, designconsiderations,
energy expected to be used or delivered by the device,and a descriptionof the operational principles
of the device.
• A device that has undergone a significant change or modificationthat could significantly affectthe
safety or effectiveness of the device,or the device is to be marketed for a new or differentindication
for use (MUST include appropriate supporting data to demonstrate that the manufacturer has
consideredwhat consequences and effects the change or modificationor new use might have on the
safety and effectivenessof the device)
• A 510(k)summary as described in 807.92 or a 510(k)statement as described in 807.93
• A financial certificationor disclosure statementor both
• The 510(k) submitter shall also certify that a reasonable search of all information known or otherwise
available about the class III device and other similar legally marketed devices has been conducted
(class III certification),as described in 807.94.FDAmay require the submissionof the adverse safety
and effectiveness datadescribed in the class III summary or citation

510(k) Content
1. Medical Device User Fee Cover Sheet(Form FDA 3601)
2. CDRH Premarket Review SubmissionCoverSheet
3. 510(k)Cover Letter
4. Indications for Use Statement
5. 510(k)Summary or 510(k) Statement
6. Truthful and Accuracy Statement
7. Class III Summary and Certification
8. Financial Certification or Disclosure Statement
9. Declarations of Conformityand Summary Reports
10. Executive Summary
11. Device Description
12. Substantial Equivalence Discussion
13. Proposed Labeling
14. Sterilization and Shelf Life
15. Biocompatibility
16. Software
17. Electromagnetic Compatibilityand ElectricalSafety
18. PerformanceTesting – Bench
19. PerformanceTesting – Animal
20. PerformanceTesting – Clinical
21. Other
• Approximately 20 Sections + RTA Checklist
• Create a Template: http://bit.ly/510k-ToC
• eCopy Guidance: http://bit.ly/FDA-eCopy
• RTA Checklist: http://bit.ly/Acceptance-
Checklist

510(k) Content
Section 1.0 – Medical Device User Fee (MDUFA) Cover Sheet
FDAForm 3601 (01/07)
https://userfees.fda.gov/OA_HTML/UserFee_Account_Creation.pdf
https://userfees.fda.gov/OA_HTML/MDUFA510KCScreation.pdf
FDA will not accept your submission if your company has not paid an establishment registration fee that is due to FDA. If
this is your first device, you have to register and pay the fee within 30 days of entering into an operation that requires you to
register and submit device listing information.
1. Register online by providing the following information:
▪ Employer Identification Number (EIN), Dun & Bradstreet Number (DUNS), or Organization Number
▪ Contact Name ▪ Company Name ▪ Address ▪ City ▪ State ▪ Zip Code ▪ Country ▪ Telephone ▪ Fax ▪ E-mail
2. Fill out the Medical Device User Fee Cover Sheet. Please answer a series of questions regarding the type of
application being submitted for FDA's review. You will have the opportunity to view the cover sheet in draft form before
submitting it to FDA.
3. When you are done, click the SUBMIT button to complete the cover sheet submission process. A form will appear with
an electronically generated user fee payment identification number that is located in the upper right-hand corner, beginning
with the letters MD. This number will assist FDA in tracking your payment and submission for the review process.
4. Submitting Payment: send a printed copy of the completed Cover sheet along with a check, bank draft, or U.S. Postal
money order made payable to the Food and Drug Administration for the fee amount due. Remember to include the
Payment Identification Number, beginning with 'MD', and the FDA P.O. Box on the enclosed check.
FY 2018 EstablishmentRegistration: $4,624 (no small business waiver)
FY 2018 510(k)Application: $10,566(from $4,690 FY2017);Small Business:$2,642

510(k) Content
Section 2.0 – CDRH Premarket Review Submission Cover Sheet
FDAForm 3514
• The CDRH Premarket Review SubmissionCoverSheet is a voluntary form used to help provide basic
administrative information for all types of submissions
• It’s about 5 pages,containing 9 sections
• The first few sections (sections A – D) are basic information
about the type of submission,reason for submission,and applicant.
• SectionE is asking about the PREDICATE device.SectionF
is asking about YOUR device.
• And finally, a reminder to checkthat the indications for use
statement on the form matches the indications foruse statement
used in the rest of the submission.(This is one of the biggest
reasons FDA rejects 510(k) submissions.)

510(k) Content
Section 2.0 – CDRH Standards Data Report
FDAForm 3654
FDA RECOGNIZED CONSENSUS STANDARDS:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
EXAMPLES OF STANDARDS INCLUDED IN THE REPORT (DEVICE DEPENDENT):
• ISO 14971 “Medical devices - Applications of risk management to medical devices” – APPLICABLE TO ISO 14971
COMPLIANT COMPANIES
• ISO 10993-1 “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management
process” APPLICABLE TO STERILIZED DEVICES

510(k) Content
FDAForm 3654
FDA RECOGNIZED CONSENSUS STANDARDS:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
• Search for RecognizedStandard to which your company is declaring compliance
• Standards for you device are found using productcode and classification database
• Note the Recognition Number,Title of Standard,and the StandardDesignation Number and Date
for Completing FDAForm 3654

510(k) Content
FDAForm 3654

Section 3.0 – 510(k) Cover Letter (FDA Form 3514)
Be sure your cover letter includes all of the following:
Administrative Information
• Type of 510(k) submission, Abbreviated or Traditional
• Your device type in plain terms, i.e., by its common name
• 510(k) submitter by name, title, and phone number
• Your preference for continued confidentiality (21 CFR 807.95)
• Your recommended classification regulation
• Class (i.e., whether it is unclassified or a class I, II, or III device)
• Review (medical specialty) panel
• FDA product code
• Any FDA document numbers associated with prior formal correspondence with FDA (e.g., IDE, pre-IDE, 510(k), PMA,
request for designation (RFD)) related to your device.
Basis for the Submission
• New device introduced for the first time
• Modification of a legally marketed device
• New indication for use
• New device design
• Reprocessed
• Single-use disposable device
Design and Use of the Device
• Intended for Rx or OTC use?
• Contains components derived from tissue/biologic source?
• Single Use? Sterile? Implanted?
• Software?
• Does the submission include clinical data?
510(k) Content

IntendedUse: General purpose of the device or it’s function, and encompassesthe indications for use
-Indicationsfor Use: As defined in 21 CFR 814.20(b)(3)(i),describes the disease or conditionthe
device will diagnose,treat, prevent, cure, or mitigate, including a descriptionof the patient population (or
location) for which the device is intended.
• Must have consistentindications throughout your 510(k), including the IFU labeling, etc.
• Must state whether the device is intended for Rx use and/or OTC use.
• RecommendedFormatfor Indications for Use Statement (Form FDA 3881)
• Include Indications from Applicable Regulation(copy and paste intended use directly from regulation)
• Include Indications from Primary Predicate
• Include Indications for SubjectDevice
• Considerreimbursementstrategy, intellectual property,
Section 4.0 – Indications for Use Statement
FDAForm 3881,21 CFR 807.87
You have to prove substantial equivalence of the indications for use between your device and the predicate device.
https://www.greenlight.guru/blog/intended-use-and-indications-of-use
510(k) Content

Section 4.0 – Indications for Use Statement
FDAForm 3881,21 CFR 807.87
ProductCode:MPN
Class: II [not 510(k)exempt]
SpecialControls Guidance
Applicable Regulations:21 CFR 878.4010
IntendedUse from Regulations
“a device intended for topical closure of surgical incision
including laparoscopicincisions,and simple traumatic
lacerations that have easily approximated skin edges.Tissue
adhesives for the topical approximation of skin may be used in
conjunction with, but not in place of, deep dermalstitches.”
Indication from PrimaryPredicate
“(Company)TopicalSkin Adhesive is intended fortopical
applications only to hold closed easily approximated skin
edges of wounds from surgical incisions, including punctures
from minimally invasive surgery, simple,thoroughly cleansed,
trauma induced lacerations. (Company)Topical skin Adhesive
may be used in conjunction with, but not in place of, dermal
sutures.”
510(k) Content

Section 5.0 – 510(k) Summary or Statement
21 CFR 807.93
510(k)Summary:brief summary of the device and supporting information
• High –level discussionof the content within the 510(k)
• Must include elements in 21 CFR 807.92
• Must include sufficientdetail to provide understanding of the basis for a determination of SE
• FDAwill verify the accuracy and completenessof the 510(k) Summary information during review
510(k)Statement:certificationthat the 510(k)holder will provide a copy of the 510(k), with exclusions,to
any personwithin 30 days of written request.
“Pursuant to 21 CFR 807.93,I certify that, in my capacity as (the positionheld in company by person
required to submit the premarket notification, preferablythe officialcorrespondentin the firm), of (company
name), I will make available all information included in this premarket notification on safety and
effectivenesswithin 30 days of requestby any person if the device describedin the premarket
notification submissionis determined to be substantially equivalent. The information I agree to make
available will be a duplicate of the premarket notification submission,including any adverse safety and
effectivenessinformation, but excluding allpatientidentifiers,and trade secretand confidential
commercialinformation,as defined in 21 CFR 20.61.”
Guidance –The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], Appendix B. The
510(k) Summary Document Requirements
510(k) Content

Section 6.0 – Truthful and Accuracy Statement
As Required by 21 CFR 807.87(k)
I certify that, in my capacity as (the position heldin company)of (company name), I believe to the best of
my knowledge,that all data and information submitted in the premarket notification are truthful and
accurate and that no material fact has been omitted.
_____________________________
(Signature)
______________________________
(Typed Name)
______________________________
(Date)
_______________________________
*(Premarket Notification [510(k)] Number)
*For a new submission,leave the 510(k) number blank.
Must be signed by a responsible personof the firm required to submit the premarket notification [e.g., not
a consultantfor the 510(k)submitter].
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotificati on510k/ucm142707.htm
510(k) Content

Section 7.0 – Class III Summary and Certification
As Required by 21 CFR 807.94
“I certify that, in my capacity as (the positionheldin company)of (companyname)that I have conducted a
reasonable search of all information known or otherwise available about the types and causes of safety
and/or effectivenessproblems that have beenreported forthe (devicename).I further certifythat I am
aware of the types of problemsto which the (devicename)is susceptible and that, to the bestof my
knowledge,the following summary of the types and causes of safety and/or effectivenessproblems about
the (devicename)is completeand accurate.”
Attach the summary ofproblem data,bibliography orothercitationsupon which the summaryis based.
___________________________
(Signature of Certifier)
___________________________
(Typed Name)
____________________________
(Date)
____________________________
*(Premarket Notification [510(k)] Number)
This is to be submitted when claiming equivalenceto a Class III device notrequiring PMA (e.g., 21
CFR 888.3070:Pedicle ScrewSpinal System;Class III Preamendment Device (510k not PMA)
• *For a new submission,leave the 510(k) number blank
• Must be signed by a responsible personof the firm required
to submit the premarketnotification [e.g., not a consultant
for the 510(k)submitter]
510(k) Content

Section 7.0 – Class III Summary and Certification
As Required by 21 CFR 807.94
This is to be submitted when claiming equivalenceto a Class III device notrequiring PMA (e.g., 21
CFR 888.3070:Pedicle ScrewSpinal System;Class III Preamendment Device (510k not PMA)
“As substantial equivalence is not claimed to a Class III device,21 CFR 807.94 is not applicable to this
premarket notification [510(k)] submission.”
IF NOT APPLICABLE…
510(k) Content

Section 8.0 – Financial Certification and Disclosure Statement
21 CFR 54; FDA Form 3454
If you didn’t perform any clinical studies as part of testing the device,you can simply include a single
sentence: “No clinicalstudieswere performed to testthis device.”
There are three differentforms that you might need to use if Clinical Data was used to test the device:
• The Financial Certification(FDA Form 3454)is used if you did not pay the clinical investigators
enough money that it might impact the results. What does that mean? It means that outside of paying
for the costs of the study, there was no equity interest or payment of another kind (such as a grant)
given to the clinical investigators.
• The Disclosure Statement(FDA Form 3455)is used if you did pay the clinical investigators. Part of
that form includes submitting the details of how you mitigated any bias.
• Certificationof Compliance with Requirements of ClinicalTrials.gov Data Bank (FDA Form 3674):
Under 42 U.S.C. § 282(j)(5)(B)
510(k) Content

Section 9.0 – Declarations of Conformity and Standard Summary Reports
• If the 510(k) is an Abbreviated submission, or another type but submitter wishes to claim conformance, this section
should include information regarding any declarations of conformity to a standard or a summary report recommended in
any relevant device-specific guidance.
• FDA suggests the use of FDArecognized consensus standards. For many standards, conformance may be declared in
the submission instead of submitting test reports to demonstrate compliance.
• Provides information regarding any declarations of conformity to a standard or summary report recommended in any
relevant device-specific guidance
• If you choose to rely on a recognized standard or a guidance for any part of the device design or testing, you may include
either a:
1. Declaration of Conformity to the standard or summary report recommended in any relevant device-specific
guidance; or
2. A statement that testing will be conducted and meet specified acceptance criteria before the device is marketed
(use sparingly, or not at all)
-Used to simplify and streamline the 510(k) review process
-Sponsors can only declare conformance to FDA recognized consensus standards
-Must document extent of conformance in 510(k) application (Form FDA 3654 -Standards Data Report for 510(k)s)
510(k) Content

Section 9.0 Continued – Guidance Documents
Represents FDA's currentthinking on a topic
•May be device specific or general
•Does not create or conferany rights for or on any personand does not operate to bind FDAor the public
•Alternative approaches may be used if the approach satisfies the requirements of the applicable statutes
and regulations
•FDAGuidance DocumentDatabase:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
Is there alwaysa specialcontroldoc to refer to for a 510k (traditional/abbreviated)?
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm0
71413.pdf - Guidance for Industry and FDA Staff Dental Handpieces - Premarket Notification [510(k)]
Submissions
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm356
190.pdf - Content of Premarket SubmissionsforManagement of Cybersecurity in Medical Devices
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm482
022.pdf - Postmarket Management of Cybersecurityin Medical Devices-
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm074973.htm -
Guidance -FrequentlyAsked Questions on Recognitionof Consensus Standards:
510(k) Content

Section 10.0 – Executive Summary
Executive Summaryis not released on the internetafter substantial equivalence determination has been made.Include a more d etailed summaryof testing results
This sectionof the submissionshould include an executive summary of the 510(k), which should include:
• A concise descriptionof the device,including the indications for use and technology;
• A device comparisontable; and
• A concise summary forany performancetesting in the submission
510(k) Content

Section 11.0 – Device Description
As required by 21 CFR 807.92(a)(4)
Device Descriptionis not just the brief descriptionyou’ve beenusing over and over again.
Rememberall those designcontrols you have beendocumenting? We’re going to be pulling up the
designhistory file and designcontrols contents and printing out copies from here on out. From your
designoutputs, grab the detailed drawings (completewith dimensions and tolerances)for each device,
accessory,and component.
Does any part of your device come into patient contact? You’ll want to list those components and include
the material specifications.If there are any applicable device-specific guidance documents,make sure
you any of the requirements in the device description.
The device descriptionsectiongets the FDAreviewer intimately familiar with your device.
510(k) Content

Section 11.0 – Device Description
11.2: Device Description
11.2.1: Principle ofOperation
11.2.2: Mechanism ofAction
11.2.3: Key DeviceFeatures
11.2.4: EnergySourceand Other Device
Features
11.3: Device Identification
Under this subsection,the following key device
components are described.In addition, all model
numbers (if known) are provided with detailed
explanation of the differences among the models
11.4: Device Characteristics
11.4.1: Drugs,If Applicable
11.4.2: Software,If Applicable
11.4.3: Biologics,If Applicable
11.4.4: Coatings,If Applicable
11.4.5: Single Use,If Applicable
11.4.6: Metals,If Applicable
11.4.7: Additives,If Applicable
11.4.8: (Non)sterile,If Applicable
11.4.9: SterilizationMethod,If Applicable
11.5: Environmentof Use
11.5.1: HealthcareFacility/Hospital
11.5.2: Home,Ambulatory,or Other
11.6: Materialsof Use
11.6.1: GeneralTypeof MaterialUsed
• Recombinantly-produced polymer
• Polymer(e.g. plastic or rubber
• Polysulfone
• Metal
• Stainless steel,etc.
11.6.2: Durationand Type ofContact
If FDA recognized consensus standard(s)are
used, provide the info at least (ASTM F####-
last 2 numbers of the year)
510(k) Content

Section 12.0 – Substantial Equivalence Discussion
Section513(i) of FD&C Act;21 U.S.C. 360c(i);21 CFR 807.92(a)(3)
A submitter of a 510(k) submission must demonstrate to FDAin its 510(k) that the new device is Substantially Equivalent to
a “predicate device”. A predicate device is a device that (i) was legally marketed prior to May 28 1976 (preamendments
device), for which a premarket approval application (PMA) is not required; or (ii) has been classified or reclassified into
Class I or II; or (iii) has been found Substantially Equivalent through the 510(k) process.
Pursuant to the statutory requirements under Section513(i)(1)(A) of the FederalFood,Drug, and
Cosmetic Act, this new device (NAME)is substantiallyequivalent in principle and performance to
the predicate (K######) device legally marketed in the US for the (INDICATIONS FOR USE)
Substantial Equivalence is defined in section 513(i) of the FD&CAct
Utilize 510(k) Decision-Making Flowchart
510(k) review standard is comparative (i.e. new device compared to predicate device)
Multiple predicate devices are ok under certain circumstances
Split predicates are inconsistent with 510(k) regulatory standard
Reference devices may be used to support scientific methodology or standard reference values (are not predicates)
• The basis for the 510(k) submission is to show that your new device is safe and effective, by demonstrating your device
is a lot like another device (predicate) that’s already been reviewed and cleared by FDA
• Predicate device(s): trade name, model number, 510(k) holder/number
• It’s time to essentially go step-by-step through the devices and show how the indications for use, technology, and
performance are the same or equivalent
• Seeing as the Executive Summary included a table comparison (from Section 10.0), I’d recommend starting there
• Create an easy to read table that specifically calls out indications for use, technology, and performance
• Please don’t include ridiculously long paragraphs of details in the table. Keep it short and to the point. Make it easy for
your FDA reviewer to find the information they need
• Consider creating a color-coded labeling matrix to enhance similarities between indications
• Make sure to include Substantial Equivalence Flowchart located @: www.fda.gov/cdrh/ode/dd510kse.pdf
• Don’t forget to include Substantial Equivalence Rationale Discussion
510(k) Content

510(k) Content
SE Decision Tree Questions
1. Is the predicate device legally marketed?
2. Do the devices have THE same intended use?
3. Do the devices have the same technological
characteristics?
4. Do the different technological characteristics raise
different questions of safety and effectiveness?
(5A) Are the methods of evaluating new/different
characteristics acceptable (Risk Mitigation Plan)
(5B) Does the data demonstrate substantial
equivalence?

9.1: SubstantialEquivalenceDiscussion
Predicate device name
Predicate device 510(k) number
9.1.1: Device Comparison Table
Table 1. ComparisonBetweenNew Device and the
Predicate Device(s)
• Intended Use
-Indications For Use
• TechnologicalCharacteristics
-Materials
-Design
-Energy Source
-Other Features
• Performance Data
-Biocompatibility
-Electrical Safety and Electromagnetic
Compatibility (EMC)
-Software verification and validation
-Mechanical and acoustic testing
-Animal Study
-Clinical Study
510(k) Content
9.1.2: Summary of Performance Testing
-Biocompatibility
-Electrical Safety and Electromagnetic
Compatibility (EMC)
-Software verification and validation
-Mechanical and acoustic testing
-Animal Study
-Clinical Study
9.1.3: SubstantialEquivalence RationaleDiscussion

Crafting Persuasive Substantial Equivalence Arguments
We need to acknowledge the differences if they are to our advantage and show that, although they exist, they will not
impact the safety, efficacy, or performance of the device. If the differences are not to our advantage, however, we should not
bring them up prophylactically but be prepared to respond to them if and when we are asked. This gets into a more
sophisticated regulatory strategy, but to use another metaphor this is a poker game, and just because you know the rules
does not make you a good poker player!
Similarities between the devices are described as follows:
• The new device has the same intended use/indications for use as the predicate device
• The new device being compared to its predicated device(s) has information of acceptable clinical and/or scientific
methods and data.
• The new device has the same technological characteristics as the predicate device (design, materials, energy source,
and other features of the devices
• The new device doesn’t raise different questions of safety and effectiveness than the predicate device
• All the data presented demonstrate substantial equivalence and support the indications
9.1.3: Substantial Equivalence Conclusion
1) Both national and international consensus standards recognized by FDA have been used to demonstrate device
performance in addition to compliance with the relevant sections of 21 CFR 820. The new device has no particular aspects
or concerns not addressed by recognized consensus standards or by conformance to 21 CFR 820.
AND/OR
2) Substantial equivalence between the new device and its legally marketed predicate device(s) has been demonstrated.
Thus, this new device is as safe and effective as the predicate device(s)
FDA Modernization Act of 1997: FDA shall only request necessary information and shall consider the least burdensome means of demonstrating
substantial equivalence.
510(k) Content

Section 13.0 – Proposed Labeling
21 CFR 807.87(e)
Proposed Labeling is going to be pulled straight from your design outputs.
Grab a copy of your device label, but don’t stop there. Labeling is more than just the label.
It includes your device label, your instructions for use (IFU), package insert, and any patient labeling.
While this should be your final version, it’s a good idea to expect some changes to come during the review and approval
process.
Also note that the FDAconsiders information on your website about your product as labeling too. (While we are on the
subject of websites, remember that you are not allowed to market your device prior to receiving 510(k) clearance.)
In the next few section, we’re going to start getting into the testing required for your 510(k) submission. As we start to go
into more details on what’s required, keep a couple of things in mind.
First and foremost, if a section isn’t applicable to your device, don’t just skip it. You need to include the section and a brief
explanation stating why it’s not applicable.
Second, when presenting test results, include both the protocol and the report. The FDAwants to see the results of the
testing. Without reports, there’s no proof that your device is safe and effective.
Comply with Device Labeling Requirements (21 CFR 801)
•Copies of all proposed labels, labeling, package inserts, service manuals, instructions for use, advertising and/or
promotional materials
•The directions for use should include a specific intended use statement and any warnings, contraindications, or limitations
•Labeling submitted should be final draft
•Copies of labeling for the predicate device is recommended
•Don’t Forget UDI Requirements
510(k) Content

Section 14.0 – Sterilization and Shelf Life
• Relevant forsterilized devices
• Relevant standards will vary depending on sterilization method
• Primary guidance document,Updated 510(k) Sterility Review Guidance K90-1,
• Guidance for Re-Processed Devices
• Typically both shelf-life testing results and protocolexpected. Acceleratedaging accepted.
510(k) Content

Section 15.0 – Biocompatibility
Formal guidance, Use of International Standard ISO-10993,'BiologicalEvaluation of Medical Devices Part
1: Evaluation and Testing',
• Helpful to summarize testing – test, method,results, conclusion(pass/fail) but many review groups still
want the actual reports
• Biocompatibility testing can be time consuming and expensive;careful research and thought can
sometimesreduce both
510(k) Content

Section 16.0 – Software
FDArecommendsaddressing software using these three guidance documents:
• Software validation:
• Software contained in Medical devices
• Off the shelf software
510(k) Content

Section 17.0 – Electromagnetic Compatibility and Electrical Safety
The contents of Section 17.0 – Electromagnetic Compatibility and Electrical Safety will depend on your device.
If you’ve got electrically powered components, regardless of whether those components are in patient contact or not, you’re
going to need to evaluate its electromagnetic compatibility (EMC). In laymen’s terms, you’re looking at whether your device
interferes with other devices (either deliberately or accidentally) or can be interfered by other devices. It’s like proving your
device is an island.
The good news is that there’s a recognized standard for the EMC testing, IEC 60601-1-2 Medical Electrical Equipment --
Part 1: General Requirements for Safety; Electromagnetic Compatibility-- Requirements and Tests (Second Edition, 2001).
There are also a ton of companies out there who are able to take care of the testing for you.
The other part of Section 17.0 depends on whether the electrically powered components are in patient contact.
If they are, you need to prove the device is safe for the patient. Once again, IEC has come to the rescue. IEC 60601-1
Medical electrical equipment - Part 1: General requirements for safety and don’t forget about Amendment 1 (1991) and
Amendment 2 (1995).
Wondering whether or not you should even bother with those parts IEC 60601 for the EMC and Electrical Safety testing?
Have you checked out the RTA checklist? It very clearly states that you’ve done testing to those standards and then gives
you an out by adding the words “or other FDA recognized standard”.
But did you check out the list of recognized standards? Unless your device is an active implantable device or a wheelchair,
you don’t really have any other choices.
• Electronic components should be evaluated for electromagnetic compatibility (EMC) IEC 60601-1- 2 or equivalent
method to demonstrate the EMC characteristics and IEC 60601 1 (electrical safety) or an equivalent method
• Check for device specific guidances & specific revisions (may be different US/EU)
510(k) Content

Section 18.0 – Performance Testing - Bench
Part of proving substantial equivalence is comparing the performance characteristics of your device to the
predicate device.These sections are where you include all of the proof for the SE comparisonyou did in
Section12.0.
Check for device specific guidance documents before planning any performance testing
Lookfor any device-specific standards (e.g.ASTM F483)
Review predicate device 510(k) Summaries carefully
Order 510(k)submissions through FOI
If the submissioncontains bench test results to supportsubstantial equivalence include:
• Descriptionof the bench testing protocolsand results supporting device performancecharacteristics
- list the specific benchtests conducted and objectives
- describe eachtest protocoland procedures(including specifictestconditions, deviations, etc.)
- study endpoint, i.e. the specific parametermeasured
- pre-definedacceptance orpass/fail criteria
- summarize the results
- describe your analysis and conclusions
Submissionshould present data derived from testing in a clear and concise form,such as a table.
Conclusions describeany comparisontesting with the predicate device in terms of substantial
equivalence.
Necessaryperformance tests depend on the complexityof the device and its intended use and indications
510(k) Content

Section 19.0 – Performance Testing - Animal
If the submissionincludes animal test results to supportsubstantial equivalence describethe tests and
provide results that supportthe device performance characteristics.
The animal performance sectionof the submissionshould include:
list the specificanimal tests conducted
describeeach test protocol
summarize the results
describeyour analysis
discuss your conclusions
The descriptionof test protocols should identify the:
objective of the test
test articles used in the test
test methods and procedures (including any specifictestconditions)
study endpoint,i.e., the specific parametermeasured
pre-definedacceptanceor pass/fail criteria.
In the summary briefly presentthe data derived from testing in a clear and concise form,such as a table.
In the conclusions describe any comparisontesting with the predicate device in terms of substantial
equivalence. Some FDAreview groups are increasingly sophisticated.Forexample, animal experts may
want to see all pathology pictures to draw their own conclusions
•
•
•
•
510(k) Content

Section 19.0 – Performance Testing - Animal
• IACUC agency allows rationales for reduction of sample number in order to spare the lives of animals
• Try to find another submissionor 510(k) summary that specifies the number of animals
• Simulated Use Studies, Cadaveric Studies
• Testmore than once per animal or your device and the predicate in each animal (i.e., animal is it’s
own control)
• Small animal vs large animal and duration
510(k) Content

Section 20.0 – Performance Testing - Clinical
Not all 510(k)s require clinical data. 10-15% of 510(k) submissionrequire clinical study data
LEVERAGE POSTMARKET SURVEILLANCE 522 STUDIESIN LEW OF CLINICAL DATA
Clinical data may be requested inthe following situations:
-New or Modified Indications for Use – Same Intended Use
-Significant TechnologicalDifferences
-Non-clinical Testing are Limited or Inappropriate Because of the Indications for Use or Technology
If you determine clinical testing is necessary,make sure you are following the applicable regulations.
The first step will be to determineif your study is significantor non-significantrisk.
• If your study is determined to be significant risk, you’ll need to conductthe study under the IDE
regulations(21 CFR Part 812). If not, there are abbreviated requirements in 21 CFR Part 812.2(b).
• Regarless of the risk level, if you are sponsoring a clinical trial, you must complywith the regulations
governing institutionalreviewboards(IRB) (21 CFR Part 56) and informed consent(21 CFR Part
50)
510(k) Content

Section 20.0 – Clinical
If the submission includes clinical studies to demonstrate substantial equivalence the submission should include the
following information in this section.
objective of the test
test methods and procedures (including any specific test conditions)
study endpoints (usually both safety and effectiveness)
statistical methodology used
case report forms and the informed consent document used in the study.
The submission should also include a discussion of the study results, analyses performed (including statistical, as
appropriate), and conclusions.
Include conclusions discussing any comparison testing with the predicate device in terms of substantial equivalence
FDA will always consider alternatives to clinical studies when the proposed alternatives are supported byan
adequate scientific rationale.
Recommendations for clinical testing typically depend on many factors including device type, intended use, design,
safety profile, and clinical experience.
510(k) Content

Section 21.0 – Risk Mitigation
1. Risk Management Framework & Planning
Defining any risk management process in compliance with the regulations like FDA or ISO needs to be established by a risk
management framework. This framework includes the process which will be used to develop the device, as well as the roles
and responsibilities of people associated with the device development project. Along with this, a proper documentation of
the risk management plan is also required to be established as a part of the risk management framework for medical
devices.
2. Risk Analysis
The risk analysis stage will help the device manufacturers direct their risk management efforts towards defining the intended
use of the product. This will help in focusing on the necessary steps, overviewing the relevant hazards (potential sources of
harm). During this stage, the foreseeable hazards needs to be identified as early as possible for assessing the risk. It is
interesting here to note that while assessing risks, the process of identifying potential harms should not only consist of
finding the causes but also the potential risk related to them.
3. Risk Evaluation
Identifying severity and occurrence (probability) of risks will help in quantifying and evaluating the risk. Suppose, there i s a
hazardous situation (very likely to occur), but with low harmful effects and there is another situation where the possibility of
harm is very high, then proper visualization of the risk on a matrix is a good idea for deciding which hazard needs to be
tackled first.
4. Risk Control
Once the risk has been identified, the next step is to control the risk, where the actual implementation of risk mitigation takes
place. The aim of risk control is to mitigate or lower the intensity of risk to an acceptable level. There are several ways to
mitigate or control a risk: One way it can be done is by changing the design of the product to a level where the risk is
mitigated, but that’s not always possible. The next option is to integrate protective measures in accordance with a particular
risk and decrease the occurrence of harm. The last thing is labeling or adding instructions in the device manual regarding
the risks involved in a particular device.
510(k) Content

MostImportant510(k)Sections
Section4 – Indications for Use (1st
)
Section5 – 510(k) Summary (4th
)
Section10 – Executive Summary (my last)
Section11 – Device Description(2nd
)
Section12 – Substantial Equivalence (3rd
)
Why I PrepareSection 4.0 Indications for Use First
• This sectionis short and mandatory
• Can be completedeven if the designis in progress
• The header identifies the title of the submissionwhich is used in all other sections
• The content identifies the proposed primarypredicate
• The content identifies the indications for use stated in the applicable regulation
Where Indicationsfor Use (Section 4)Appear
• 510(k) Cover Letter
• Section4 – Indications for Use
• Section5 – 510(k) Summary
• Section9 – Declaration of Conformity& Summary Reports
• Section10 – Executive Summary
• Section11 – Device Description
• Section12 – Substantial Equivalence
• Section13 – Labeling (must appear in the IFU)
510(k) Content

Introduction to 510(k) Project Planning
Use Table of Contents as ProjectPlanning Tool!
Red=info that does not appear to be available
Yellow=documentrequires revision and/or reformatting of
content
Blue=ready for the client’s review and approval
Green=readyfor submission
*prioritize task completion
510(k) Planning
1. Medical Device User Fee Cover Sheet (Form FDA 3601)
2. CDRH Premarket Review Submission Cover Sheet
3. 510(k) Cover Letter
4. Indications for Use Statement
5. 510(k) Summary or 510(k) Statement
6. Truthful and Accuracy Statement
7. Class III Summary and Certification
8. Financial Certification or Disclosure Statement
9. Declarations of Conformity and Summary Reports
10. Executive Summary
11. Device Description
12. Substantial Equivalence Discussion
13. Proposed Labeling
14. Sterilization and Shelf Life
15. Biocompatibility
16. Software
17. Electromagnetic Compatibility and Electrical Safety
18. Performance Testing – Bench
19. Performance Testing – Animal
20. Performance Testing – Clinical
21. Other

Presentation Outline
Writing a Compelling and Persuasive 510(k)
Key Considerations
Informationis completeand organized
Include a table of contents
Use tabs and paginate properly
Utilize tables and graphs appropriately and effectively
Use visual aids whenever possible
Clearly identify basic 510(k) requirements (e.g. 510(k) Summary, Indications for Use Form,etc.)
Be consistentthroughout the submission
Follow current applicable guidance documents and device specificchecklists
• When justifying to the FDA why you chose your predicate device,consideralso describing why you
chose to not use devices X,Y, Z as your predicate device forsubstantial equivalence determination.
• While drafting your substantial equivalence discussion,rememberto not only compare similarities
betweenyour device and your predicate,but you should also outline the differencesbetweenyour
device and your predicate and why those differencesare negligible.
• No promissorystatements are accepted
510 is a marketing / legal document that may
protect you against liability…It is also a
persuasive document. Style, content, format,
details matter.

55
Leaning Objective
510(k) Common Questions From Reviewers
1. Please provide me with copies ofdocuments in word.
2. Testprotocols and reports
-Verificationand/or validation test protocols and reports
3. Summary of tests and/or justifications
4. Summary of software tests including risk analysis and mediation of anomylies
-Various tests including human factors/usability tests
5. Interpretation of test results
6. Statistical tools, analysis, and/or justification
7. Risk analysis reports and/or clarification
8. Manufacturing process
9. Device descriptions
10. LABELING CLAIMS

510(k)SubmissionProcessand Timeline
-RTA Policy
-eCopy Submission
-presub, 513g
• Guidance released February 18, 2014
• Consultants and RA Experts have beenusing
these foryears but weren’t called “pre-sub”
meetings
• Do you homework 1st
• In-personvs Tcon
• Timing = PRIOR to Performance Testing
• IdentifyProposed Predicate Device(s)
Day 1: FDAreceives 510(k) submission
By Day 7
By Day 15
By Day 60
By Day 90
By Day 100
FDA sends Acknowledgement Letter OR Hold Letter
FDA completes Acceptance Review and informs submitter if 510(k) is
accepted for Substantive Review or placed on RTA Hold
FDA completes Substantive Review and communicates via
Substantive Interaction to inform submitter if 510(k) w illproceed w ith
Interactive Review or that the 510(k) w illbe placed on hold and
Additional Information is required
FDA sends final MDUFA Decision on 510(k)
If MDUFA Decision is not reached by Day 100, FDA provides Missed
MDUFA Decision Communication that identifies outstanding review
issues

eCopy
eCopy Program for Medical Device Submissions
What is an eCopy?
• An exactduplicateof the papersubmission
• Created and submitted on a compactdisc (CD), digital video disc (DVD), or a flash drive
• An eCopyis accompaniedby a copyof the signed cover letter and the complete papercopy
• Section745A(b)of the FD&C Act, as added by section1136 of FDASIA
• The cover letter must also include one of the following eCopystatements”
• …the eCopyis an exact duplicate of the paper copy;OR
• …the eCopyis an exact duplicate of the paper copyexcept[specifyall differences]
• FDAGuidance “eCopyProgram for Medical Device Submissions Issuedon December31,2012
esubmitter
Questions regarding eCopy requirements or responses to eCopy holds should be sent to: CDRH-eCopyinfo@fda.hhs.gov

eCopy
eCopy Program for Medical Device Submissions
Questions regarding eCopy requirements or responses to eCopy holds should be sent to: CDRH-eCopyinfo@fda.hhs.gov

Content of a 510(k) Submission
Quality in 510(k) "Quik" Review Program Pilot
On September, 6, 2018, the FDA launched the Quality in 510(k) ("Quik") Review Program to
provide an alternate method to submit a premarket notification (510(k)) to the FDA using
the eSubmitter software to format the submission. The FDA has identified a list of product
codes that are eligible for this pilot. These device types are moderate risk and are
considered to be well-understood by the FDA. This means the FDA believes these products
can be reviewed in an efficient manner while still maintaining safety and effectiveness. The
goal is for the FDA to make a final decision within 60 days of receipt of a 510(k) for an
eligible device.
The purpose of the Quik Review Program pilot is to evaluate the Quik Review Program and
whether use of the FDA's free eSubmitter software will produce well-organized submissions
that can be reviewed more efficiently to help promote timely access to safe, effective, and
high-quality medical devices.

Common 510(k) Mistakes Resulting in RTA Hold or Requests for Additional Information
• Results in 1 of 3 paths within 15 days of receipt:
- 510(k) is accepted for substantivereview or
- 510(k) isn’taccepted for review = RTA or
- 510(k) is under substantivereview FDA
didn’t complete acceptance review within
15 days (doesn’thappen often, if at all)
• Rate of submissions notaccepted (based on RTA)
- 2,965 510(k)s received in 2013
- 1,197 Accepted; 1,715 RefuseTo Accept
- RY 2013: 58%; FY2014: 56%
• Failureto state whether a condomdevice was patient contacting
• Failureto explain how following the Specials ControlGuidance Documentfor labeling met the labeling
requirements under 21 CFR 807.87
• 510(k) Summary formatting comments
• Failureto comply with a DraftGuidancedocument
• Failureto indicate whether a vinylglove contained softwareor met the electrical safety requirements
• Substantivequestions regarding shelf-lifeand other content that should be the subjectof review not RTA
• Typos, misprints, duplicatepages, etc.
FDA Law Blog. February 26, 2014

Further Your 510(k) Learning – Additional Resources
• 17 Blogs about 510(k) Submissions
- http://medicaldeviceacademy.com/category/510k
• 5 On-Demand 510(k) Webinars
- http://medicaldeviceacademy.com/510k_submission_predicate_device/
References
Contentof a 510(k):
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotificatio n510k/ucm142651.htm
•510(k) Format Tips:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm142648.htm
Guidance –Recognition and Use ofConsensus Standards: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm077274.htm
Guidance -Frequently Asked Questions on Recognition ofConsensus Standards:
Recognized Consensus Standards Database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm#
Standards Data Form (Form FDA 3654): http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM081667.pdf
How to Prepare a Traditional 510(k):
http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm134572.htm
•How to Prepare An Abbreviated 510(k):
•How to Prepare A Special 510(k):
http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotificatio n510k/ucm134573.htm
•510(k) Screening Checklist:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotificatio n510k/ucm071360.htm
•510(k) Forms:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070202.htm
Is a new 510(k) required for a modification to the device?:
Guidance -Deciding When to Submita 510(k) for a Change to an Existing Device (K97-1):

Learning Objectives
1. To understand how to selecta predicate device for your 510(k) submission
2. To understand how to collectand organize the data and actually prepare the 510(k)
3. To understand FDAForm 3654:Standards Data Report
4. To understand 510(k) tips and bestpractices,potential pitfalls and commonmistakes
Questions?

AdvaMed 510(k) Submissions Workshop: How to Assemble A Bullet Proof 510(k) Submission for the FDA

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AdvaMed 510(k) Submissions Workshop: How to Assemble A Bullet Proof 510(k) Submission for the FDA