Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
A brief introduction on medical device , how iit is regulated in india,its marketing authorization,classification, notified devices,import of device and registration process, fnctions of medical device department.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
A brief introduction on medical device , how iit is regulated in india,its marketing authorization,classification, notified devices,import of device and registration process, fnctions of medical device department.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
January 29, 2014 Presentation to Compliance2Go webinar, focusing on:
• Legal Framework for 510(k)’s
• Strategy Considerations – Claims & Functions
• Device Modifications
• Regulatory Mechanisms to Implement Changes
• The Review
• What To Do if FDA Says You’re NSE
• Key Lessons Learned
• Reform and Other Recent Trends at FDA
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
Japan Medical Device Regulatory Approval ProcessKate Jablonski
Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, outlines some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
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.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
January 29, 2014 Presentation to Compliance2Go webinar, focusing on:
• Legal Framework for 510(k)’s
• Strategy Considerations – Claims & Functions
• Device Modifications
• Regulatory Mechanisms to Implement Changes
• The Review
• What To Do if FDA Says You’re NSE
• Key Lessons Learned
• Reform and Other Recent Trends at FDA
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
Japan Medical Device Regulatory Approval ProcessKate Jablonski
Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, outlines some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
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.
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.
Medical device regulation is complex, in part because of the wide variety of items that are categorized as medical devices.
They may be simple tools used during medical examinations,
such as tongue depressors and thermometers, or high-tech life-saving devices that are implanted in the patient, like pacemakers and coronary stents.
The federal agency responsible for regulating medical devices is the Food and Drug
Administration (FDA)—an agency within the Department of Health and Human Services (HHS).
A manufacturer must obtain FDA’s prior approval or clearance before marketing many medical
devices in the United States.
FDA’s Center for Devices and Radiological Health (CDRH) is primarily responsible for medical device premarket review.
Another center, the Center for Biologics Evaluation and Research (CBER), regulates devices associated with blood collection and processing procedures, cellular products and tissues.
Under the terms of the Medical Device Amendments of 1976
FDA classified all medical devices that were on the market at the time of enactment— the Pre amendment devices—into one of three classes.
Congress provided definitions for the three
classes—Class I, Class II, and Class III—based on the risk (low-, moderate-, and high-risk
respectively) to patients posed by the devices.
A PMA is “the most stringent type of device marketing application required by FDA” for new and/or high-risk devices.
PMA approval is based on the application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s)
PMAs generally require some clinical data prior to FDA making an approval decision.
All clinical evaluations of investigational devices (unless exempt) must have an investigational device exemption (IDE) before the clinical study is initiated.
An IDE allows an unapproved device (most commonly an invasive or life-sustaining device) to be used in a clinical study to collect the data required to support a PMA submission.
The IDE permits a device to be shipped lawfully for investigation of the device without requiring that the manufacturer comply with other requirements of the FFDCA, such as registration and listing.
A PMA must contain (among other things) the following information:
summaries of nonclinical and clinical data supporting the application and conclusions drawn from the studies;
a device description including significant physical and performance characteristics;
indications for use, description of the patient population and disease or condition that the device will diagnose, treat, prevent, cure, or mitigate;
a description of the foreign and U.S. marketing history, including if the device has been withdrawn from marketing for any reason related to the safety or effectiveness of the device;
proposed labeling; and
a description of the manufacturing process.
If a manufacturer wants to make a change to an approved PMA device.
AzCI presents: Medical Device Regulations through the FDAAnitaBell
Arizona Center for Innovation (AzCI) presents: Working with Your Demographic Market (in orphan drug development)
This presentation is part of a series developed for a workshop on "How to Navigate the Biotech Regulatory Process"
The Arizona Center for Innovation is an incubator and innovation center and provides resources in support of startups getting to the next level and become successful enterprises.
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
Federal Regulatory Issues Us Food And Drug Administration Medical Device Amen...Jacobe2008
Authors:
Harvard-MIT Division of Health Sciences and Technology HST.535: Principles and Practice of Tissue Engineering Instructors: Myron Spector
Massachusetts Institute of Technology
Harvard Medical School Brigham and Women's Hospital VA Boston Healthcare
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
Devices Sponsor Information Day: 0 - Developments in medical device regulationTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
The challenges of regulating direct to consumer digital medical devicesTGA Australia
Presentation on digital medical devices, the role of the regulator, challenges in applying the framework to digital devices, international approaches and what is the TGA doing
Device registration and listing of medical devices on the US marketttopstart B.V.
We provide an overview of the regulations and legislations with regard to commercialisation of medical devices in the US. The product category of medical devices ranges from class I devices up to class III devices. In the US, market approval is granted by the FDA (Food and Drug Administration) upon assessment of quality, safety and effectiveness.
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.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
Navigating the Health Insurance Market_ Understanding Trends and Options.pdfEnterprise Wired
From navigating policy options to staying informed about industry trends, this comprehensive guide explores everything you need to know about the health insurance market.
Struggling with intense fears that disrupt your life? At Renew Life Hypnosis, we offer specialized hypnosis to overcome fear. Phobias are exaggerated fears, often stemming from past traumas or learned behaviors. Hypnotherapy addresses these deep-seated fears by accessing the subconscious mind, helping you change your reactions to phobic triggers. Our expert therapists guide you into a state of deep relaxation, allowing you to transform your responses and reduce anxiety. Experience increased confidence and freedom from phobias with our personalized approach. Ready to live a fear-free life? Visit us at Renew Life Hypnosis..
3. About US-FDA
• Part of the U.S. Department of Health and Human
Services
• Protect public health by ensuring medical
devices’
– safety
– efficacy
Amongst others……
• Helps speed innovations that make medical
products more effective, safer, and more
affordable…..
4. What does FDA regulate?
• Foods: dietary supplements, bottled water, food additives, infant formulas
• Drugs: prescription drugs (brand-name and generic), non-prescription (OTC drugs)
• Biologicals: vaccines, blood and blood products, cellular and gene therapy
products, tissue and tissue products, allergenics
• Medical Devices:
– simple items like tongue depressors and bedpans,
– complex technologies such as heart pacemakers
– dental devices
– surgical implants and prosthetics
• Electronic Products that give off radiation, including:
– microwave ovens
– x-ray equipment
– laser products
– ultrasonic therapy equipment
– mercury vapor lamps
– Sunlamps
• Cosmetics, Veterinary Products, Tobacco Products
6. Safety & Effectiveness
• “So to market a medical device in the United
States, we have to follow the Federal Food, Drug,
and Cosmetic Act, or the FD&C Act.”
• Center for Devices and Radiological Health, or
CDRH, evaluates the evidence for the safety and
effectiveness of medical devices.
• Safety means that the device poses no significant
risk to users, or that the risks are mitigated,
meaning they can be adequately controlled.
• Effectiveness means the device can treat the
disease as labeled.”
7. Laws Enforced by FDA
• Food and Drugs Act of 1906
• The Federal Food, Drug, and Cosmetic Act of 1938 was passed after
a legally marketed toxic elixir killed 107 people
– The law authorized FDA to demand evidence of safety for new drugs,
issue standards for food, and conduct factory inspections.
• The Kefauver-Harris Amendments of 1962, which were inspired by
thalidomide tragedy in Europe (FDA's vigilance prevented drug's
marketing in US)
– Strengthened rules for drug safety and required manufacturers to
prove their drugs' effectiveness.
• The Medical Device Amendments of 1976 followed a U.S. Senate
finding that faulty medical devices had caused 10,000 injuries,
including 731 deaths.
– The law applied safety and effectiveness safeguards to new devices.
9. Marketing Medical Device in US
• Medical devices marketed US are subject to
– the regulatory controls in the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and
– the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts
1-58, 800-1299.
– Medical devices that emit radiation are also subject to regulations for
radiation-emitting electronic products cited in 21CFR Parts 1000-1050.
• Premarket requirements
1. Classify Your Device
2. Choose the Correct Premarket Submission
3. Prepare Appropriate Information for Premarket Submission
4. Send Premarket Submission and Interact with FDA Staff during
Review
5. Complete the Establishment Registration and Device Listing
10. 1. Classify Device
• Class I – Lowest Risk
An example of a Class I device is a hand held stretcher.
Class I devices are subject to general controls.
• Class II – Moderate Risk
Examples of Class II devices are Ethylene oxide gas
steriliser and non-invasive blood pressure monitors.
Class II devices are subject to general controls and
special controls.
• Class III – Highest Risk
An example of Class III device is a heart valve. Class III
devices are subject to general controls and premarket
approval.
15. Regulatory Controls
• General Controls-
– Apply to all medical devices.
– Provisions that relate to
• adulteration;
• misbranding;
• device registration and listing;
• premarket notification;
• banned devices;
• notification, including repair, replacement, or refund;
• records and reports;
• restricted devices; and
• good manufacturing practices.
16. Special Controls
• Usually device-specific and include
– Performance standards
– Post-market surveillance
– Patient registries
– Special labeling requirements
– Premarket data requirements
– Guidelines
17. Performance standards-CT
• Information to be provided for users
– Conditions of operation
– Dose information at various locations
– Imaging performance information
• A statement of the noise
• graphical presentation of the modulation transfer function
• statement of the nominal tomographic section thickness
• graphical presentation of the sensitivity profile
• phantom or device and test protocol or procedure
– Quality assurance
– Control and indication of conditions of operation
– Tomographic plane indication and alignment
– Beam-on and shutter status indicators
– Scan increment accuracy
– CT number mean and standard deviation
18. Marketing Medical Device in US
• Medical devices marketed US are subject to
– the regulatory controls in the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and
– the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts
1-58, 800-1299.
– Medical devices that emit radiation are also subject to regulations for
radiation-emitting electronic products cited in 21CFR Parts 1000-1050.
• Premarket requirements
1. Classify Your Device
2. Choose the Correct Premarket Submission
3. Prepare Appropriate Information for Premarket Submission
4. Send Premarket Submission and Interact with FDA Staff during
Review
5. Complete the Establishment Registration and Device Listing
19. Controls in US FDA Medical Devices
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
HDE (Humanitarian Device Exemption)-Class III devices for patients with rare diseases
Humanitarian Use Device (HUD)-FDA’s Office of Orphan Products Development(OOPD)
20. 510 (k)
Predicates
Devices legally marketed
in the U.S. before May
28, 1976 not significantly
modified, regulation
requiring a PMA
application not published
by FDA.
"grandfathered" and do
not require a 510(k).
Inventory and classification
Class III device notified to FDA prior to marketing
Good Manufacturing Practice (GMP) regulations
21. When You Can’t identify a predicate!!
• Clinical Study and PMA (Class III) (Premarket Approval)
– Quarter million dollar and 2 year process
– Novel, technology and high risk device
– sponsor must provide valid scientific evidence demonstrating reasonable assurance of
safety and effectiveness for the device’s intended use.
• De Novo Submission
– new device, without a valid predicate (Class I or II)
• Develop special controls guidance document
• How to be evaluated for performance, safety and efficacy?
– 510(k) exempt
• 510(k)(Premarket Notification)
• Pre-submission Meeting
– Product early stage of development, identify classification and predicate selection,
performance planning, etc.
• 513(g) submission
– Ask FDA to identify a predicate
22. Marketing Medical Device in US
• Medical devices marketed US are subject to
– the regulatory controls in the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and
– the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts
1-58, 800-1299.
– Medical devices that emit radiation are also subject to regulations for
radiation-emitting electronic products cited in 21CFR Parts 1000-1050.
• Premarket requirements
1. Classify Your Device
2. Choose the Correct Premarket Submission
3. Prepare Appropriate Information for Premarket Submission
4. Send Premarket Submission and Interact with FDA Staff during
Review
5. Complete the Establishment Registration and Device Listing
27. Marketing Medical Device in US
• Medical devices marketed US are subject to
– the regulatory controls in the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and
– the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts
1-58, 800-1299.
– Medical devices that emit radiation are also subject to regulations for
radiation-emitting electronic products cited in 21CFR Parts 1000-1050.
• Premarket requirements
1. Classify Your Device
2. Choose the Correct Premarket Submission
3. Prepare Appropriate Information for Premarket Submission
4. Send Premarket Submission and Interact with FDA Staff during
Review
5. Complete the Establishment Registration and Device Listing
30. 3. 510(k) Submission Process
• Premarket Notification (510(k)submissions for
medical devices are reviewed by
– Center for Devices and Radiological Health (CDRH),
• Office of Device Evaluation (ODE) and
• Office of In Vitro Diagnostics and Radiological Health (OIR).
– The Divisions in these offices are organized according
to medical device specialties.
– biomedical engineers, physicians, microbiologists,
chemists, and other scientific professionals.
31. Timeline of
Communication during
510(k) Review
Acceptance review
•assess whether a
submission is
administratively complete
•RTA Hold-180days
•Substantive Review
Review of 510(k)
submission &
communication through
a Substantive Interaction
• Interactive Review
Resolve outstanding
deficiencies 90d
•AI Request-on hold 180d
Medical Device User Fee Agreement 2012
MDUFA Decision for a 510(k) is 90 FDA Days
35. How to Search for a Predicate Device
• “ Product Code Classification Database”
• “Classify Your Medical Device”
• Information which can be useful to find a predicate device includes:
– names of similar devices - traded name under which the device is
marketed;
– manufacturer(s) of the similar device(s);
– marketing status, i.e., pre-amendments or post-amendments device;
– 510(k) numbers for post-amendments devices;
– classification information, i.e., product codes, classifying regulations,
etc., for your device.
• 510(k) database
• FDA assigns a unique 3-letter product code or "procode" for each
generic category of device- best search
36. Product Classification
• Identify a similar device
• Use the registration and listing database
• Identify the 3-letter product code
• Click on the code product classification page
• Click on TPLC link
42. Technological characteristics
• Materials
• Design
• Energy Source
• Other features
• Same ≠ Equivalent
– Does not raise DIFFERENT issues of safety or
effectiveness
– Must be as safe and effective as predicate
43. Split Predicates
• 1st Predicate has same intended use
• 2nd Predicate has same technological
characteristics
This is not allowed
44. Multiple Predicates allowed..
• Option 1:
– Two predicates with different technological
characteristics 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
45. Example
• 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, escision, ablation, vapourisation
of soft tissue
– New performance testing 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
specific indications and technological characteristics
46. Example
• Multi-parameter monitor
– New monitor includes different technologies-use
of infra-red..
– Predicate for each parameter-same intended use
– Monitoring of each parameter cannot interfere
with others
– New performance testing may be required
47. Equivalence Data
• Intended use
• Technological characteristics
– Material, design, energy source, other features
• Performance data-sections where details found,
list the documents
– Biocompatibility
– Electrical safety & Electromagnetic compatibility
– Software verification and validation
– Mechanical and acoustic testing
– Animal Study
– Clinical Study
48. Sections in a 510(k)
• Medical Device User Fee Cover
Sheet (Form FDA 3601)
• CDRH Premarket Review
Submission Cover Sheet
• 510(k) Cover Letter
• Indications for Use Statement
• 510(k) Summary or 510(k)
Statement
• Truthful and Accuracy Statement
• Class III Summary and
Certification
• Financial Certification or
Disclosure Statement
• Declarations of Conformity and
Summary Reports
• Executive Summary
• Device Description
• Substantial Equivalence
Discussion
• Proposed Labeling
• Sterilization and Shelf Life
• Biocompatibility
• Software
• Electromagnetic Compatibility
and Electrical Safety
• Performance Testing – Bench
• Performance Testing – Animal
• Performance Testing – Clinical
• Other
49. CDRH Premarket Review Submission
Cover Sheet
• Type of submission
• Applicant/ correspondent
• Product information
– Common or usual name or classification name
– Trade or Proprietary or Model Name for This Device
– Model Number
– FDA document numbers of all prior related submissions (regardless of
outcome)
– Data Included in Submission
• Laboratory Testing, Animal Trials, Human Trials
• Product Classification
• Manufacturing / Packaging / Sterilization Sites Relating To A Submission
• Utilization Of Standards
• Standards No., Standards Organization, Standards Title, Version Date
50. 510(k) Cover Letter
Administrative Information
– type of 510(k) submission
– device type in plain terms, i.e., by its common name;
– 510(k) submitter; contact person, by name, title, and phone number;
– preference for continued confidentiality (21 CFR 807.95);
– recommended classification regulation;
– class (i.e., whether it is unclassified or a class I, II, or III device).
– product code; and
– prior formal FDA document numbers
Basis for the Submission
– new device/ design/ indication for use/ modification of a legally
marketed device
51. 510(k) Cover Letter
• Design and Use of the Device (yes/no)
– Is the device intended for prescription use (21 CFR 801 Subpart D)?
– Is the device intended for over-the-counter use (21 CFR 807 Subpart C)?
– Does the device contain components derived from a tissue or other biologic
source?
– Is the device provided sterile?
– Is the device intended for single use?
– Is the device a reprocessed single use device?
– If yes, does this device type require reprocessed validation data?
– Does the device contain a drug?
– Does the device contain a biologic?
– Does the device use software?
– Does the submission include clinical information?
– Is the device implanted?
52. Indications for Use Statement
• Compare device’s indications for use (IFU)
statements to IFU of predicate device, including
any specific intended uses.
• The usual IFU for Full Field Digital
Mammography System (FFDM ) system is:
– The (device name) is indicated for generating
mammographic images that can be used for screening
and diagnosis of breast cancer.
– The (device name) is intended to be used in the same
clinical applications as traditional film/screen systems.
– incorporate diagnostic examples
53. 510(k) Summary
• 510(k) owner's & device’s details
• legally marketed device equivalence claimed
• description of device found in labeling or promotional material for device
– Incl. explanation of how device functions,
– scientific concepts forming basis for device,
– significant physical and performance characteristics
• device design, material used, and physical properties
• Intended use
– general description of diseases or conditions
– patient population for which device is intended.
– If indication statements different from predicate, explanation
• why differences are not critical to intended therapeutic, diagnostic prosthetic, or surgical
use
• Why differences do not affect safety and effectiveness of the device when used as
labeled
54. 510(k) Summary
• Summary of technological characteristics of device compared to predicate
• If determination SE based on non-clinical performance data
– discussion of nonclinical tests submitted, referenced, or relied
– how their results support a determination of substantial equivalence
• If determination SE based on clinical performance data
– discussion of clinical tests submitted, referenced, or relied
– how their results support a determination of SE
– description of subjects
– safety or effectiveness data
– specific reference to adverse effects and complications,
Clinical data is not needed for most devices cleared by the 510(k) process
• Conclusions drawn from nonclinical and clinical tests that demonstrate
device is as safe, as effective, and performs as well as or better than the
predicate device
55. Standards in SE Determinations
• FDA recognises more than 400 standards
– Manufacturers may use FDA-recognized standards
to meet 510(k) requirements by submitting :
• a declaration of conformity- data in files at time of
510(k) submission
• a statement-such data before a device is marketed
– Manufacturers may also use non-recognized
standards
• there is less assurance that these standards will be
acceptable.
58. Executive Summary
• Concise description of device
– Incl. indications for use and technology
• Device comparison table-
– differences and similarities bet. device & predicate
– discussion of how this comparison supports SE
• Summary for performance testing
– type of testing performed, methods, conclusion
59. Device Description
• Performance specifications
• Device design requirements
• Identify all models, accessories, components
• Diagrams, dimensions, tolerances, schematics
• List of patient contacting components & their
respective materials
60. Substantial Equivalence Discussion
• Detailed comparison between the device and
predicate sufficient to demonstrate SE in
terms of:
– indications for use;
– technology; and
– performance specifications, including any testing.
61.
62.
63. Sec. 807.100 FDA action on a
premarket notification.
(b) FDA will determine that a device is substantially equivalent to a predicate device
using the following criteria:
(1) The device has the same intended use as the predicate device; and
(2) The device:
(i) Has the same technological characteristics as the predicate device; or
(ii)(A) Has different technological characteristics, such as a significant change in the
materials, design, energy source, or other features of the device from those of the
predicate device;
(B) The data submitted establishes that the device is substantially equivalent to the
predicate device and contains information, including clinical data if deemed
necessary by the Commissioner, that demonstrates that the device is as safe and
as effective as a legally marketed device; and
(C) Does not raise different questions of safety and effectiveness than the predicate
device.
(3) The predicate device has not been removed from the market at the initiative of
the Commissioner of Food and Drugs or has not been determined to be
misbranded or adulterated by a judicial order.
[57 FR 58403, Dec. 10, 1992, as amended at 63 FR 5253, Feb. 2, 1998]
64. Decision-Making
• Identify the new device and the predicate device.
• Decision 1 Is predicate device legally marketed? YES
• Review all labeling and assure that it is consistent
with IFU statements
• Decision 2 Do devices have same intended use? YES
• Review design, materials, energy source and other
features of the devices.
• Decision 3 Do the devices have the same
technological characteristics? Yes SE
NO=NSE
65. Decision-Making
• NO Determine what questions of safety and
effectiveness the different technological characteristics
raise
• Decision 4 Do different technological characteristics
raise different questions of safety and effectiveness?
NO
• Review proposed scientific methods for evaluating
new/ different characteristics’ effects on safety and
effectiveness.
• Decision 5a Are the methods acceptable? YES
• Evaluate performance data
• Decision 5b Do the data demonstrate SE? YES SE
66. Proposed Labeling
• Copies of all proposed
– Labels-'display of written, printed, or graphic matter upon immediate
container of any article...'
– labeling, all labels and other written, printed, or graphic matter
• upon any article or any of its containers or wrappers, or
• accompanying such article' at any time while a device is held for sale after shipment or
delivery for shipment in interstate commerce
– package inserts,
– service manuals,
– instructions for use,
– advertising and/or promotional materials.
– directions for use
• a specific intended use statement
• warnings, contraindications, or limitations.
• Labeling should be final draft.
• Copies of labeling for predicate device(s) is recommended.
67. Sterilization and Shelf Life
• Sterilization method
• Sterilization site
• Dose in case of radiation sterilization
• Chemical: maximum levels of sterilant
residuals that remain on the device
• Method used to validate the sterilization cycle
• Sterility assurance level
• Pyrogenicity testing
68. Biocompatibility
• If device contains components that come into
direct or indirect contact with patients
• Evaluate biocompatibility of all patient tissue
contacting surfaces of device following ISO-
10993, Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing
methodsor provide equivalent testing
information.
69.
70.
71. Software
• Level of concern: Failure / Flaw leading to injury
– Major Concern - death or serious injury
– Moderate Concern - minor injury
– Minor Concern - unlikely to cause any injury
• Software Description- features and operating environment
• Device Hazard Analysis
• Software Requirements Specification
• Architecture Design Chart
– functional units and software modules
– state diagrams as well as flow charts
• Software Design Specification
72. Software
• Traceability Analysis
– among requirements, specifications, identified hazards and
mitigations, and Verification and Validation testing
• Software Development Environment Description
– Summary of software life cycle development plan.
– List of control documents generated during development
process.
– Configuration management and maintenance plan documents.
• Verification and Validation Documentation
– V&V activities, integration, test protocols , pass/fail criteria, test
report, summary, and tests results
• Revision Level History
• Unresolved Anomalies(Bugs or Defects)
73. Electromagnetic Compatibility and
Electrical Safety
• If device design includes an electronic component ,
– evaluate its electromagnetic compatibility (EMC).
– EMC encompasses both
• emissions (interference with electronic products) and
• immunity (interference with device performance by emissions from other
electronic products).
• Test device according to
– IEC 60601-1- 2 Medical Electrical Equipment -- Part 1: General
Requirements for Safety;
– Electromagnetic Compatibility -- Requirements and Tests (Second
Edition, 2001)
• If device design results in patient contact with any electrically
powered component,
– Follow IEC 60601 1 (1988): Medical electrical equipment - Part 1:
General requirements for safety, including Amendment 1 (1991) and
Amendment 2 (1995) or an equivalent method.
74. Performance Testing – Bench/Animal
• List the specific bench tests conducted
• Describe each test protocol
– objective of the test
– test articles used in the test
– test methods and procedures (including any specific test
conditions)
– study endpoint, i.e., the specific parameter measured
– pre-defined acceptance or pass/fail criteria.
• Summarize the results
• Describe your analysis- clear and concise, table
• Discuss your conclusions
– comparison testing with predicate in terms of SE
75. Performance Testing – Bench/Animal
Bench testing
• ASTM testing methods
• Simulated use experiments
• Validated tools (known
input data for
software/hardware devices)
• Finite Element Analysis
• Cadaveric Studies
Animal Studies
• Rationales for reduction of
sample no. in order to spare
lives of animals
• Another 510(k) submission
that specifies no.
• Test more than once per
animal
• Small vs. large and duration
76. Performance Testing – Clinical
• 10-15% of submissions
• Objective of the test
• Test methods and procedures (including any specific test conditions)
• Study endpoints (usually both safety and effectiveness)
• Statistical methodology used.
• Study results, analyses performed (including statistical, as appropriate)
• Conclusions-comparison testing with predicate device in terms of SE.
• Study is considered significant risk, conducted under the IDE regulation,
21 CFR Part 812 if it is conducted in the United States
• If, however, study is considered non-significant risk, the study is subject to
the abbreviated requirements of 21 CFR Part 812.2(b) only.
• In all cases, sponsors of clinical trials must comply with regulations
governing institutional review boards (21 CFR Part 56) and informed
consent (21 CFR Part 50).
77. Steps in the PMA Application Process
• Filing review
• Statistical review for filing
• Review of manufacturing information for compliance
with the Quality System regulation (21 CFR 820).
• PMA filing decision
• Day-100 Meeting
• Quality System Inspection(s) by the FDA field
personnel.
• Bioresearch Monitoring (BIMO) Audit (audit of clinical
study data)
78. Steps in the PMA Application Process
• Substantive review coordination and completion in areas such as:
– Preparation of FDA Summary of Safety and Effectiveness Data (SSED)
– Nonclinical Studies
[Microbiological, Toxicological, Immunological, Biocompatibility, Shelf
Life, Analytical (for IVDs), Animal, Engineering (Stress, Wear, Fatigue,
etc.)]
– Clinical Studies
– Panel Meeting Decision and Mailing (if panel meeting is appropriate)
– Panel Date (if appropriate)
– Transcripts Received, Reviewed and Placed in Administrative Record
– QS/GMP Clearance
– Final Response from OC for GMP/BIMO
– Final ODE Decision Memo
– Approval Package
– Approval Order, SSED, Final Draft Labeling
80. • Manufacturers and importers must submit reports on
information that reasonably suggests that their marketed
devices may have
– caused or contributed to a death or serious injury or
– has malfunctioned
– the malfunction of the device or a similar device that they
market would be likely to cause or contribute to a death or
serious injury if the malfunction were to recur.
• Manufacturers must send reports of such deaths, serious
injuries and malfunctions to the FDA.
• Importers must send reports of deaths and serious injuries
to the FDA and the manufacturer, and reports of
malfunctions to the manufacturer.
81. MAUDE - Manufacturer and User
Facility Device Experience
• Each year, the FDA receives several hundred thousand
medical device reports (MDRs) of suspected device-
associated deaths, serious injuries and malfunctions.
• The FDA uses MDRs to monitor device performance,
detect potential device-related safety issues, and
contribute to benefit-risk assessments of these
products.
• The MAUDE database houses MDRs submitted to the
FDA by mandatory reporters (manufacturers, importers
and device user facilities) and voluntary reporters such
as health care professionals, patients and consumers.
83. MAUDE Adverse Event Report
VYAIRE MEDICAL, INC 3100 High Frequency Oscillatory Ventilator (HFOV) Ventilator, High
Frequency
Model Number 3100A
Device Problems Failure to cycle; Device operates differently than expected
Event Date 07/23/2017
Event Type Malfunction
Event Description
The customer reported that the amplitude setting dropped and the device stopped cycling. The
customer was unaware of any patient involvement and had no further information. The
customer reported requesting a Vyaire onsite service evaluation.
Manufacturer Narrative
Any additional information received from the customer will be included in a follow-up report. A
Vyaire field service representative (FSR) evaluated the device onsite. The FSR checked the
unit and found a faulty mean airway pressure (map) meter, which would display fluctuating
map readings. The FSR performed a two thousand hour (2k) preventative maintenance
procedure and other manufacture testing, which did not identify any other assembly failures.
Having passed all manufacture testing the device was return to the customer working to
specifications. At this time, the reported event was not duplicated however a map meter
failure was identified, which is not believed to be the cause of the reported event on this
complaint. No hardware return is expected or anticipated on this complaint therefore no
further investigation will be required.
84.
85. MAUDE Adverse Event Report
• Bunnell, inc. Bunnell life pulse high frequency ventilator Bunnell life pulse HFV
• Model Number 203
• Device Problems Device stops intermittently; Device operates differently than expected
• Event Date 06/15/2017
• Event Type Malfunction
• Manufacturer Narrative
• The reported symptom of high pip with a ventilator fault could not be verified and was not
reproduced as reported. The self test always passed with no alarms of any type generated and the
system operated in a very stable manner with minimum fluctuations of all monitored values and no
alarm conditions of any type generated. The ventilator was found to be in near perfect calibration
condition and all monitoring, processing and control circuitry was verified to be operating correctly
and responding accurately. The hfv was thoroughly inspected, tested and serviced with no
problems found that could cause or be responsible for the reported symptoms. Systems operation
was very stable at a variety of controls pip and rate settings with no alarms in the hfv ready
condition. Hfv 2799 was fully serviced and passed all applicable testing requirements. Explanation
of reporting timeframe: bunnell was notified of this customer issue on 06/19/2017. Based on the
information received at that time it was determined that this was not a reportable event. Bunnell
received the suspect device on 06/26/2017 and completed an investigation of the issue. As this
investigation concluded that there were no issues with the device the event was not reported at
the time of the investigation. However, on 07/10/2017 bunnell received user facility report (b)(4).
The complaint file has been reviewed, and this report is being submitted within 30 days of bunnell
becoming aware of the user facility's determination of event reportability.
86. • Event Description
As stated in user facility report (b)(4): "ventilator
alarmed high pip (peak inspiratory pressure), self
cycled in an attempt to reset. Alarmed high pip
again and then shut down reading ventilator
fault. Patient was hand ventilated and suffered no
harm". As reported to bunnell: "we had a jet go
down while on patient, no patient injury. The jet
alarmed high pip twice and then ventilator fault.
The therapist turned off the jet and back on.
Would not test and indicated vent fault. ".
87.
88. Limitation of MAUDE
• Passive surveillance system
– potential submission of incomplete, inaccurate, untimely, unverified,
or biased data.
– Incidence or prevalence of an event cannot be determined due to
• potential under-reporting of events
• lack of information about frequency of device use.
• Alone cannot be used to
– establish rates of events,
– evaluate a change in event rates over time or
– compare event rates between devices
– about the existence, severity, or frequency of problems associated
with devices
89. Limitation of MAUDE
• Cause-and-effect relationship difficult
– if circumstances surrounding event not verified or
– if the device in question not directly evaluated
• MAUDE search limited to reports of past 10 years.
• MAUDE data does not represent all known safety
information
• Variations in trade, product, and company names affect
search results.
• MAUDE is updated monthly and search page reflects
date of most recent update.
• Inclusion of some reports may be delayed.