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A failure of the device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. A malfunction should be considered reportable if any one of the following is true:
1. The chance of a death or serious injury
2.The malfunction affect the device in a catastrophic manner that may lead to a death or serious injury
3. The device fail to perform its essential function
4. The malfunction would be likely to cause or contribute to death or serious injury, regardless of how the device is used.
The De Novo 510(k) Process - Is There Hope at FDA for Lower Risk Innovative D...Michael Swit
Review of the de novo 510(k) Petition process that allows for the reclassification of innovative devices that are automatically placed into Class III by FDA.
A failure of the device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. A malfunction should be considered reportable if any one of the following is true:
1. The chance of a death or serious injury
2.The malfunction affect the device in a catastrophic manner that may lead to a death or serious injury
3. The device fail to perform its essential function
4. The malfunction would be likely to cause or contribute to death or serious injury, regardless of how the device is used.
Mobile Medical Apps and FDA Regulatory ApproachAkshay Anand
A presentation on Food Safety and Standards Authority of India. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during March 2015
Did you know that between January and June of 2015, 69% of 510(k) applications were rejected their first time?
Even though there have been significant changes to the content required in a 510(k) submission since the agency released their guidance in 2005, this should not be the case.
So what can you do to better manage your team’s 510(k) expectations?
How can you piece together your submission in a way that’s least likely to be rejected?
Join us for this free, 60 minute webinar, presented by our guest Allison Komiyama, PhD, RAC, principal consultant at AcKnowledge Regulatory Strategies and a former FDA reviewer.
Allison will be sharing with you some of her insider tips and best practices so you have a better chance at receiving your clearance letter faster than your competitors!
(You can view the full free webinar here: http://www.greenlight.guru/webinar/fda-510-k-submission)
Specifically, you will learn:
-Insider tips, tricks and best practices to getting your device to market faster
-What exactly are the expectations for your 510(k)?
-What does the 510(k) timeline look like and how long is it going to take?
-How to avoid having your 510(k) rejected
-What happens to your 510(k) once it’s submitted to FDA?
-What does the 510(k) pathway really look like?
-How to prepare your 510(k) submission
In this presentation we want to outline the principles of medical device regulations and the 510(k) Premarket notification process for an efficient product approval with the FDA.
General Principals Of Software Validationstaciemarotta
This guidance outlines general validation principles that the Food and Drug Administration (FDA)
considers to be applicable to the validation of medical device software or the validation of software
used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0,
supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June
9, 1997.
As part of device description, required by 21 CFR 807.92(a)(4), medical device manufacturers will have to present how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, materials used, physical, chemical and biological properties.
HIGHLIGHTED: Guidance for Industry: Internet/Social Media Platforms: Correcti...NextWorks
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Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
When these guidances come out, I typically go through them and highlight the most relevant portions for those who need to skim through or refresh their memory.
HIGHLIGHTED: Guidance for Industry: Fulfilling Regulatory Requirements for Po...NextWorks
This is the highlighted version of FDA's Guidance for Industry
Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics from January 2014.
When these guidances come out, I typically go through them and highlight the most relevant portions for those who need to skim through or refresh their memory.
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
This PDF will discuss the key information that is required for a medical device 510k submission. The information presented in this PDF pertains to just one of the many best practices in a medical device 510K preparation and submission.
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Getting through the FDA review as quickly as possible requires a clear understanding of the development standards, documentation and testing that is now expected for Medical devices. During this session we discussed how FDA hot buttons affect your medical device submission will be discussed, including:
-Requirements for software development as outlined in IEC 62304
-Content considerations for premarket submissions
-Human factors engineering as a platform for enhanced user safety
-Provisions for data security and protection against unauthorized wireless access
We reviewed the design control requirements and product development approach that can shorten your medical device's path to market with a focus on safety, human factors engineering and security.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
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ING My Industry: Dutch Manufacturing 2010, nov 2006ABN AMRO
ONE VOICE, de Nederlandse industrie bestaat uit vele verschillende branches en subbranches. Elke branche opereert in een specifieke markt en is afhankelijk van specifieke trends en ontwikkelingen. Er zin echter meer overeenkomsten dan verschillen! Dit rapport is het resultaat van een unieke samenwerking tussen alle industriële branches op zo samen aan een beter imago te werken bij het brede publiek en de wens om een krachtig signaal af te geven richting de overheid.
Het rapport is geschreven op basis van een grote landelijke enquete en bevat 10 specifieke analyses en SWATs van de belangrijkste industriële sectoren in Nederland.
Mobile Medical Apps and FDA Regulatory ApproachAkshay Anand
A presentation on Food Safety and Standards Authority of India. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during March 2015
Did you know that between January and June of 2015, 69% of 510(k) applications were rejected their first time?
Even though there have been significant changes to the content required in a 510(k) submission since the agency released their guidance in 2005, this should not be the case.
So what can you do to better manage your team’s 510(k) expectations?
How can you piece together your submission in a way that’s least likely to be rejected?
Join us for this free, 60 minute webinar, presented by our guest Allison Komiyama, PhD, RAC, principal consultant at AcKnowledge Regulatory Strategies and a former FDA reviewer.
Allison will be sharing with you some of her insider tips and best practices so you have a better chance at receiving your clearance letter faster than your competitors!
(You can view the full free webinar here: http://www.greenlight.guru/webinar/fda-510-k-submission)
Specifically, you will learn:
-Insider tips, tricks and best practices to getting your device to market faster
-What exactly are the expectations for your 510(k)?
-What does the 510(k) timeline look like and how long is it going to take?
-How to avoid having your 510(k) rejected
-What happens to your 510(k) once it’s submitted to FDA?
-What does the 510(k) pathway really look like?
-How to prepare your 510(k) submission
In this presentation we want to outline the principles of medical device regulations and the 510(k) Premarket notification process for an efficient product approval with the FDA.
General Principals Of Software Validationstaciemarotta
This guidance outlines general validation principles that the Food and Drug Administration (FDA)
considers to be applicable to the validation of medical device software or the validation of software
used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0,
supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June
9, 1997.
As part of device description, required by 21 CFR 807.92(a)(4), medical device manufacturers will have to present how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, materials used, physical, chemical and biological properties.
HIGHLIGHTED: Guidance for Industry: Internet/Social Media Platforms: Correcti...NextWorks
This is the highlighted version of FDA's Guidance for Industry
Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
When these guidances come out, I typically go through them and highlight the most relevant portions for those who need to skim through or refresh their memory.
HIGHLIGHTED: Guidance for Industry: Fulfilling Regulatory Requirements for Po...NextWorks
This is the highlighted version of FDA's Guidance for Industry
Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics from January 2014.
When these guidances come out, I typically go through them and highlight the most relevant portions for those who need to skim through or refresh their memory.
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
This PDF will discuss the key information that is required for a medical device 510k submission. The information presented in this PDF pertains to just one of the many best practices in a medical device 510K preparation and submission.
Slides presented at "Getting Your Medical Device FDA Approved" event, presented by Mentor Graphics Embedded Software, discussing how to address the enhanced scrutiny from government agencies that can introduce significant delays with the commercial release of software-related medical devices.
Getting through the FDA review as quickly as possible requires a clear understanding of the development standards, documentation and testing that is now expected for Medical devices. During this session we discussed how FDA hot buttons affect your medical device submission will be discussed, including:
-Requirements for software development as outlined in IEC 62304
-Content considerations for premarket submissions
-Human factors engineering as a platform for enhanced user safety
-Provisions for data security and protection against unauthorized wireless access
We reviewed the design control requirements and product development approach that can shorten your medical device's path to market with a focus on safety, human factors engineering and security.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
ING My Industry: Dutch Manufacturing 2010, nov 2006ABN AMRO
ONE VOICE, de Nederlandse industrie bestaat uit vele verschillende branches en subbranches. Elke branche opereert in een specifieke markt en is afhankelijk van specifieke trends en ontwikkelingen. Er zin echter meer overeenkomsten dan verschillen! Dit rapport is het resultaat van een unieke samenwerking tussen alle industriële branches op zo samen aan een beter imago te werken bij het brede publiek en de wens om een krachtig signaal af te geven richting de overheid.
Het rapport is geschreven op basis van een grote landelijke enquete en bevat 10 specifieke analyses en SWATs van de belangrijkste industriële sectoren in Nederland.
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This presentation provides an overview of the dynamic U.S. Millennial consumer segment with an emphasis on the growing Latino market. Find out why marketers can't afford to not to address this segment.
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Center for Devices and Radiological Heath
Office of Communication, Education and Radiation Programs
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Watson Megatech, Inc.
% Chad Watson
Dec 1, 2011
President and CEO
5800 Industrial Blvd
Suite 11
Omaha, NE 68135
Re: P091462
BioBanking
Filed: Jan 9, 2010
Amended: August 5, September 8 and 13, 2010; February 22, 2011; September 22, 2011; October 6, 2011 and November 1, 2011.
Procode: RLD
Dear Mr. Watson:
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration
(FDA) has completed its review of your premarket approval application (PMA) for the BioBanking Device.
BioBanking is intended to be for sub-dermal use as a radio frequency (RF) emitter in the prevention of identity theft and financial fraud. The device will interact with external scanners through radio frequency to identify the individual as well as financial account information. The device will also interact with external encoders for the purposes of addition or removal of financial account information. The device is solar powered and does not need internal batteries that would provide potential medical issues in the PMA review process.
The BioBanking insertion process can be administered by non-medical personnel trained in the implementation of the product. Financial institution personnel responsible for this administration will be trained and certified in application of the BioBanking device.
The sub-dermal BioBanking device is one element of the total transaction system. There is also a reader for the RF signals. Since the reader is a passive device it does not fall under provisions of the CDRH purview.
We are pleased to inform you that the PMA is approved. You may begin commercial distribution
of the device in accordance with the conditions of approval described below. You may continue
commercial distribution of the device upon receipt of this letter.
Page 2 – Mr. Watson
The sale and distribution of this device are governed by The Radiation Control provisions (originally enacted as the Radiation Control for Health and Safety Act of 1968) located in Sections 531 through 542 of the Act. They apply to any "electronic product" which is defined as: any manufactured or assembled product (or component, part, or accessory of such product) which, when in operation,
i. contains or acts as part of an electronic circuit and
ii. emits (or in the absence of effective shielding or other controls would emit) electronic product radiation.
"Electronic product radiation" is defined as:
i. any ionizing or non-ionizing electromagnetic or particulate radiation, or
ii. any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product.
The device is restricted under section 515(d)(l)(B)(ii) o.
Device registration and listing of medical devices on the US marketttopstart B.V.
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The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulatory procedures for specific classes of medical devices. By summarising the procedures for each class of medical device, we, ttopstart, aim to offer a guide through this dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...CRF Health
The Food and Drug Administration (FDA) recognizes the extensive variety of actual and
potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential
benefits and risks to public health represented by these apps. The FDA is issuing this guidance
document to inform manufacturers, distributors, and other entities about how the FDA intends to
apply its regulatory authorities to select software applications intended for use on mobile
platforms (mobile applications or “mobile apps”). Given the rapid expansion and broad
applicability of mobile apps, the FDA is issuing this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority.
Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. September 25, 2013
http://www.alfonsogadea.es/apps-salud-poniendo-orden/
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
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1. medical device as per usa:
a) classification
b) 510(k)
c) 510(k) submission process
d) pre market approval(PMA)
2. medical device as per india
a) definition
b) organization of medical device reviewer
c) registration process
d) document required for the registration of medical device as per cdsco
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• Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019
• Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019
• Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019
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1. Guidance for Industry and FDA Staff
Class II Special Controls Guidance
Document: Implantable
Radiofrequency Transponder
System for Patient Identification
and Health Information
Document issued on: December 10, 2004
For questions regarding the use or interpretation of this guidance contact: Gail Gantt at 240-276-3700
or by email gail.gantt@fda.hhs.gov
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
General Hospital Devices Branch
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
2. Preface
Public Comment
Written comments and suggestions may be submitted at any time for Agency consideration to
the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room
1061, (HFA-305), Rockville, MD, 20852. Alternatively, electronic comments may be submitted
to http://www.fda.gov/dockets/ecomments. Please identify your comments with the docket
number listed in the notice of availability that publishes in the Federal Register announcing the
availability of this guidance document. Comments may not be acted upon by the Agency until
the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet at:
http://www.fda.gov/cdrh/ode/guidance/1541.pdf, or CDRH Facts-On-Demand. In order to
receive this document via your fax machine, call the CDRH Facts-On-Demand system at 800-
899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the
second voice prompt, press 1 to order a document. Enter the document number (1541) followed
by the pound sign (#). Follow the remaining voice prompts to complete your request.
3. Table of Contents
1. BACKGROUND..................................................................................................................................................1
2. SCOPE..................................................................................................................................................................2
3. RISKS TO HEALTH ..........................................................................................................................................3
4. RECOMMENDED MITIGATION MEASURES ............................................................................................4
A. BIOCOMPATIBILITY ........................................................................................................................................4
B. INFORMATION SECURITY PROCEDURES (DESIGN AND VALIDATION)..............................................................4
C. SOFTWARE VALIDATION ................................................................................................................................5
D. MIGRATION TESTING OF IMPLANTED TRANSPONDER .....................................................................................5
E. PERFORMANCE TESTING OF IMPLANTED TRANSPONDER ................................................................................5
F. PERFORMANCE TESTING OF INSERTER............................................................................................................5
G. PERFORMANCE TESTING AND HAZARD ANALYSIS OF ELECTRONIC SCANNER ...............................................5
H. ELECTROMAGNETIC COMPATIBILITY..............................................................................................................5
I. ELECTRICAL SAFETY PERFORMANCE TESTING...............................................................................................5
J. STERILITY ......................................................................................................................................................6
K. MAGNETIC RESONANCE IMAGING COMPATIBILITY ........................................................................................6
L. LABELING.......................................................................................................................................................6
5. LIMITATIONS OF EXEMPTION FROM PREMARKET NOTIFICATION ............................................7
4. Contains Nonbinding Recommendations
1
Guidance for Industry and FDA Staff
Class II Special Controls Guidance Document:
Implantable Radiofrequency Transponder
System for Patient Identification and Health
Information
This guidance represents the Food and Drug Administration's (FDA's) current thinking on
this topic. It does not create or confer any rights for or on any person and does not operate to
bind FDA or the public. You can use an alternative approach if the approach satisfies the
requirements of the applicable statutes and regulations. If you want to discuss an alternative
approach, contact the FDA staff responsible for implementing this guidance. If you cannot
identify the appropriate FDA staff, call the appropriate number listed on the title page of this
guidance.
1. Background
This guidance document was developed as a special control guidance to support the
classification of the implantable radiofrequency transponder system for patient identification and
health information into class II (special controls). The device is intended to enable access to
secure patient identification and corresponding health information in humans. This guidance is
issued in conjunction with a Federal Register notice announcing the classification of implantable
radiofrequency transponder system for patient identification and health information.
This guidance document describes a means by which implantable radiofrequency transponder
systems for patient identification and health information may comply with the requirement of
class II special controls. Designation of this guidance document as a special control means that
manufacturers of implantable radiofrequency transponder systems for patient identification and
health information who follow the recommendations listed in this document, before introducing
their device into commercial distribution in the United States, will also be able to market their
device without being subject to the premarket notification requirements of section 510(k) of the
Act.
Section 510(m) of the Act provides that FDA may exempt a class II device from the premarket
notification requirements under section 510(k) of the act if FDA determines that premarket
notification is not necessary to provide reasonable assurance of the safety and effectiveness of
5. Contains Nonbinding Recommendations
2
the device. FDA has determined premarket notification is not necessary to provide reasonable
assurance of the safety and effectiveness of this generic type of device if the manufacturer
follows the recommendations in this special controls guidance or equivalent measures to address
the risks identified in this guidance. Thus, persons who intend to market a device of this type do
not need to submit a premarket notification to FDA and receive agency clearance prior to
marketing the device, but as a class II device, the device must comply with the other applicable
general and special controls (Section 513(a)(1)(B)).
Following the effective date of a final rule exempting the device, manufacturers of implantable
radiofrequency transponder systems for patient identification and health information will need to
address the issues covered in this special control guidance. However, the manufacturer need
only show that its device meets the recommendations of the guidance or in some other way
provides equivalent assurances of safety and effectiveness.1
If manufacturers cannot comply
with these recommendations or equivalent measures, they will not be exempt from the
requirements of premarket notification and will need to submit a premarket notification and
receive clearance for their device prior to marketing.
FDA's guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are
cited. The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.
The Least Burdensome Approach
The issues identified in this guidance document represent those that we believe need to be
addressed before your device can be marketed. In developing the guidance, we carefully
considered the relevant statutory criteria for Agency decision-making. We also considered the
burden that may be incurred in your attempt to follow the statutory and regulatory criteria in the
manner suggested by the guidance and in your attempt to address the issues we have identified.
We believe that we have considered the least burdensome approach to resolving the issues
presented in the guidance document. If, however, you believe that there is a less burdensome
way to address the issues, you should follow the procedures outlined in the “A Suggested
Approach to Resolving Least Burdensome Issues” document. It is available on our Center
web page at: http://www.fda.gov/cdrh/modact/leastburdensome.html.
2. Scope
The scope of this document is limited to the following device as described in 21 CFR 880.6300
Implantable Radiofrequency Transponder System for Patient Identification and Health
Information (product code: NRV):
1
We recommend that you document how you have addressed the recommendations in your
design history file. Manufacturers must maintain design controls, including a design history file,
in accordance with 21 CFR 820.30.
6. Contains Nonbinding Recommendations
3
An implantable radiofrequency transponder system for patient identification and health
information is a device intended to enable access to secure patient identification and
corresponding health information. This system may include a passive implanted
transponder, inserter, and scanner. The implanted transponder is used only to store a
unique electronic identification code which is read by the scanner. The identification
code is used to access patient identity and corresponding health information stored in a
database.
3. Risks to Health
In the table below, FDA has identified the risks to health generally associated with the use of the
Implantable Radiofrequency Transponder System for Patient Identification and Health
Information addressed in this document. FDA recommends the following measures to mitigate
the identified risks in this guidance, as shown in the table below.
Identified risk
Recommended mitigation measures
(See the corresponding subheading in section 4)
Adverse Tissue Reaction
A. Biocompatibility
J. Sterility
L. Labeling
Migration of implanted transponder D. Migration Testing of Implanted Transponder
Compromised Information Security
B. Information Security Procedures (Design and
Validation)
Failure of implanted transponder
E. Performance Testing of Implanted Transponder
L. Labeling
Failure of Inserter F. Performance Testing of Inserter
Failure of electronic scanner
G. Performance Testing and Hazard Analysis of
Electronic Scanner
C. Software Validation
L. Labeling
Electromagnetic Interference
H. Electromagnetic compatibility
L. Labeling
Electrical Hazards
I. Electrical Safety performance testing
L. Labeling
Magnetic Resonance Imaging
Incompatibility
K. Magnetic Resonance Imaging Compatibility
L. Labeling
Needle stick L. Labeling
7. Contains Nonbinding Recommendations
4
4. Recommended Mitigation Measures
FDA believes that conformance with this guidance document, when combined with the general
controls of the Act, will provided reasonable assurance of the safety and effectiveness of the
implantable radiofrequency transponder system for patient identification and health information.
We recommend that you (the manufacturer) evaluate your device as described below and, where
appropriate, document the results in your design history file as a part of the Quality Systems
Requirements (21 CFR 820.30).
A. Biocompatibility
We recommend that you ensure the biocompatibility of the patient-contacting parts of your
device by following the tests in the:
• International Standard Organization (ISO) standard ISO-10993, Biological
Evaluation of Medical Devices Part 1: Evaluation and Testing.
B. Information Security Procedures (Design and Validation)
When discussing the issue of medical devices that store, access, and/or transfer information
externally, you should address the concept of information security. Information security is
the process of preventing the modification, misuse or denial of use, or the unauthorized use
of that information. We recommend that your specifications for a compatible database
address the following four components of information security: Confidentiality, Integrity,
Availability, and Accountability (CIAA).
• Confidentiality means the characteristic of data and information being
disclosed only to authorized persons, entities and processes at authorized
times and in the authorized manner. (The assurance that no unauthorized
users have access to the information.)
• Integrity means the characteristic of data and information being accurate and
complete and the preservation of accuracy and completeness. (The
assurance that the information is correct (accurate and complete) - that is, it
has not been improperly modified.)
• Availability means the characteristic of data, information and information
systems being accessible and usable on a timely basis in the required manner.
(The assurance that the information will be available when needed.)
• Accountability is the application of identification and authentication to assure
that the prescribed access process is being done by an authorized user.
8. Contains Nonbinding Recommendations
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C. Software Validation
We recommend that you validate the software in your device by referring to the following
guidance:
• Guidance for FDA Reviewers and Industry Guidance for the Content of
Premarket Submissions for Software Contained in Medical Devices
http://www.fda.gov/cdrh/ode/57.html
• General Principles of Software Validation; Final Guidance for Industry and
FDA Staff
http://www.fda.gov/cdrh/comp/guidance/938.html
D. Migration Testing of Implanted Transponder
We recommend that you conduct testing of the implanted transponder to demonstrate that the
transponder will not migrate after implantation.
E. Performance Testing of Implanted Transponder
We recommend that you conduct testing of the transponder that will demonstrate that under
conditions of use the transponder sends an identification (ID) code and that the ID code is
correct. The testing should address loss or corruption of the data, latency and through-put,
and be coordinated with the electromagnetic compatibility (EMC) performance of the
implant, scanner and wireless data link.
F. Performance Testing of Inserter
We recommend that you demonstrate the functionality of the insertion device by conducting
testing that demonstrates that inserter can properly implant the transponder.
G. Performance Testing and Hazard Analysis of Electronic Scanner
We recommend that you address the functionality of the electronic scanner by conducting
performance testing and hazard analysis that demonstrate the scanner utility in reading the
transponder identification code.
H. Electromagnetic Compatibility
We recommend that you demonstrate the basic EMC of the device (i.e., transponder and
scanner together) by performing EMC testing in accordance with the following FDA-
recognized standard:
• IEC 60601-1-2 (Second Edition, 2001) Medical electrical equipment - Part1:
General requirements for safety; Electromagnetic compatibility -
Requirements and Tests, or its equivalent.
I. Electrical Safety Performance Testing
We recommend that you demonstrate the electrical safety of your device by following the
testing in:
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• IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements
for Safety
J. Sterility
We recommend that the transponder and inserter be sterile with a sterility assurance level of
10-6
. We also recommend that you address the sterility of your device by reviewing the
following:
• Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for
Industry and FDA. http://www.fda.gov/cdrh/ode/guidance/361.html.
K. Magnetic Resonance Imaging Compatibility
We recommend that you demonstrate the magnetic resonance imaging compatibility of your
device by following:
• ASTM F2052-02 Standard Test Method for Measurement of Magnetically
Induced Displacement Force on Medical Devices in the Magnetic Resonance
Environment
• ASTM F2182-02a Standard Test Method for Measurement of Radio
Frequency Induced Heating Near Passive Implants During Magnetic
Resonance Imaging
• ASTM F2213-04 Standard Test Method for Measurement of Magnetically
Induced Torque on Medical Devices in the Magnetic Resonance Environment
• ASTM F2119-01 Standard Test Method for Evaluation of MR Image
Artifacts from Passive Implants.
In addition, you should also address the EMC concerns for implant exposure to the
significant magnetic and radiofrequency emissions from MRI, including concerns for
implant malfunction or damage from MRI exposure and the use of the scanner during MRI
procedures.
L. Labeling
As a prescription device, under 21 CFR 801.109, the device is exempt from having adequate
directions for lay use.2
2
Final labeling must comply with the requirements of 21 CFR 801 before a medical device is
introduced into interstate commerce.
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We recommend that instructions delineate the technological features of the specific device
and how the device is to be used on patients. We recommend that the instructions encourage
local/institutional training programs designed to familiarize users with the features of the
device and how to use it in a safe and effective manner. If there are any precautions or
warnings, which relate to packaging or sterility, these should be repeated on the package
labels.
We also recommend that you provide after surgery care instructions to the patient. See also
Guidance on Medical Device Patient Labeling,
http://www.fda.gov/cdrh/ohip/guidance/1128.html.
5. Limitations of Exemption from Premarket Notification
FDA's decision to exempt a Class II device from the requirement of premarket notification is
based on the existing and reasonably foreseeable characteristics of devices within that generic
type that currently are, or have been, in commercial distribution. Section 21 CFR 880.9 specifies
the limitations to exemption. If any of these limitations apply, your device is not exempt and
you must submit a premarket notification.