http://MedicalDeviceEvents.com At the 10x Medical Device Conference in 2014, presenters Carrie Kuehn, Jorge Ochoa, and Robert Packard explained why, according to data from FDA, more than 58% of 510(k) submissions were refused under FDA’s Refuse to Accept (RTA) policy during its first year of implementation.
This presentation examined some of the reasons why industry got such a bad “grade.” We discussed the RTA requirements and some of the challenges from industry’s perspective on meeting the requirements of the RTA checklist and ended with recommendations on how industry can improve its odds of getting past the RTA hurdle on the first try.
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
FDA Regulations and Medical Device Pathways to Market | Kevin Daly | Lunch & ...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
FDA Regulations and Medical Device Pathways to Market | Kevin Daly | Lunch & ...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
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
Overview of FDA Drug Manufacturing RequirementsMichael Swit
Presentation on FDA Regulation of Drug Manufacturing to the Introduction to Drug Law Course sponsored by the Food & Drug Law Institute (FDLI) on July 25, 2018 in San Francisco.
Understanding FDA Requirements Medical Devicesmarchell
The medical device market is experiencing explosive growth. Currently valued at $90 billion, market growth will continue to accelerate as demographics and market drivers increase their pressure for new and innovative product offerings.
Moreover, a substantial investment of time and resources is required to properly evaluate a new product idea and estimate its potential for success. So when a company executive declines a seemingly good product idea, what is probably being declined is the expense of properly evaluating the idea, and after having paid these expenses, the prospect of embarking on an expensive commercialization effort that has a 90 percent chance of failing.
Financial Disclosure – Duties and Strategies for Clinical StudiesMichael Swit
Financial disclosure requirements for clinical studies are explored with a particular emphasis on how the requirement for tracking "Significant Payments of Other Sorts" -- or SPOOS -- present challenges in clinical study compliance.
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
Modification after Initial Review and Transparency and Real-World Performance...EMMAIntl
The next installment in our blog series on Artificial Intelligence/ Machine Learning (AI/ ML) based Software as a Medical Device (SaMD) will cover points three and four of FDA’s proposed Total Product Lifecycle (TPLC) approach: modification after initial review and transparency and real-world performance monitoring...
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
Overview of FDA Drug Manufacturing RequirementsMichael Swit
Presentation on FDA Regulation of Drug Manufacturing to the Introduction to Drug Law Course sponsored by the Food & Drug Law Institute (FDLI) on July 25, 2018 in San Francisco.
Understanding FDA Requirements Medical Devicesmarchell
The medical device market is experiencing explosive growth. Currently valued at $90 billion, market growth will continue to accelerate as demographics and market drivers increase their pressure for new and innovative product offerings.
Moreover, a substantial investment of time and resources is required to properly evaluate a new product idea and estimate its potential for success. So when a company executive declines a seemingly good product idea, what is probably being declined is the expense of properly evaluating the idea, and after having paid these expenses, the prospect of embarking on an expensive commercialization effort that has a 90 percent chance of failing.
Financial Disclosure – Duties and Strategies for Clinical StudiesMichael Swit
Financial disclosure requirements for clinical studies are explored with a particular emphasis on how the requirement for tracking "Significant Payments of Other Sorts" -- or SPOOS -- present challenges in clinical study compliance.
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
Modification after Initial Review and Transparency and Real-World Performance...EMMAIntl
The next installment in our blog series on Artificial Intelligence/ Machine Learning (AI/ ML) based Software as a Medical Device (SaMD) will cover points three and four of FDA’s proposed Total Product Lifecycle (TPLC) approach: modification after initial review and transparency and real-world performance monitoring...
Premarket Notification The 510(k) ProcessMichael Swit
June 5, 2012 presentation to the Food & Drug Law Institute Introduction to Medical Device Law Conference, Palo Alto, CA, focusing on:
I.The Legal Framework For 510(k) Determinations
II.510(k) Preparation – From Planning to Content
A. Predicates: researching predicates, combination predicates, and pre-amendment predicates
B. Strategy: choosing the right claim and introducing new features
C. Assessing data requirements/pre-IDE meetings
III. Device Modifications - Choosing The Right Regulatory Mechanism
IV.The FDA Review
V.What To Do When Your Substantial Equivalence Argument Is Rejected
V. Special Topics: User Fees, Combination Products
VI. Lessons Learned: Seeing The 510(k) From The Reviewer’s Perspective
VII. Recent Trends, 510(k) Reform
VIII. Case Study
FDA Update: Inspections, Observations and Metrics - OMTEC 2017April Bright
This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
Confused by FDA Guidance on Standardized Study Data for Electronic Submissions?Brook White, PMP
In December 2014, FDA released the finalized Guidance for Industry “Providing Regulatory Submissions in Electronic Format—Standardized Study Data.” This presentation reviews key points in the guidance and discusses the implications for Sponsors currently conducting studies as well as those who will be starting new studies soon.
Data integrity - Regulatory Perspective and Challenges: santoshnarla
Data Integrity: Regulatory Perspective and Challenges.
This presentation will present the importance of data integrity in the pharma industry with regards to the quality compliance and its impact on industry. This presentation also emphasizes on importance of regulatory affairs department in ensuring the data integrity and regulatory challenges.
Leveraging UDI Database Requirements to Drive Data GovernancePTC
Delivered at the event “UDIs and Traceability for Medical Devices 2014” in Munich, May 21 – 22, 2014, Europe's only UDI-dedicated event for the medical device industry – with keynotes from the FDA and European Commission– this slideshare presents a Solution Provider’s perspective on the impact of Master Data on the UDI submission to the FDA UDI data base. In detail, the presentation highlights the following subjects:
- A checklist for compliance – What to consider when selecting a solution for UDI data submission
- Data management as a lever for streamlined submissions – Current situation, challenges, and best practices for establishing data governance within an organization
- How PTC solutions support UDI and data governance – PTC’s UDI solution and the broader approach for central product data management
Current labs can greatly benefit from a digital transformation.
FAIR data principles are crucial in this process.
Laying a solid data governance foundation is an invaluable long-term move.
Overcoming Regulatory, Clinical and Quality Challenges in Developing Combinat...Michael Swit
Webinar presented on May 19, 2011, sponsored by The Weinberg Group, focusing on:
* A Brief History of Combination Product Regulation
* Primary Mode of Action (PMOA) –The Key Lynchpin to FDA’s Regulatory Regime for Combination Products
* The Request for Designation (RFD) Process
* GMPs
* Post-Market Safety Reporting
* How Many Applications to File?
* User Fees
12 Steps for Medical Device UDI Submissions to the FDA GUDIDJoe Hage
UDI regulations kick in for Implantables and Class II devices in 2015.
Reed Tech subject matter expert Gary Saner is my go-to on this subject. He covered:
• Requirements of a GUDID submission system
• Process steps in selecting/launching a GUDID system and making submissions
• Data Fields – including those that are problematic
• Data Cleaning, Harmonization, and Validation tips
• Update on FDA’s changing GUDID guidance, e.g., convenience kits and implants
• Notes in setting up a FDA GUDID account
RELEVANT FOR:
• UDI Team Leaders/Members
• Regulatory Directors/Managers/Staff
• Manufacturing, Operations, and Supply Chain Logistics Personnel
• UDI IT Support Personnel
• Compliance Officers
• Distributors with UDI Submission Responsibilities
Video at http://medgroup.biz/UDI-in-2015
How Medical Device Sites are Evolving 2015Joe Hage
http://medgroup.biz/device-sites for the accompanying video.
Joe Hage, leader of the Medical Devices Group, reviews how 33 life science company websites evolved over the past two years.
The presentation contains before-and-after screen captures of 33 life science company websites along with recommended references and free online tools to use in your website development and user interface testing.
WHO WILL VALUE THE PRESENTATION:
• Marketers at every level in the organization
• Business Development Executives
• VPs and Directors of Sales
• Regional Sales Managers
• Inside Sales Managers
• Medical Device Distributors
TGA changes for Medical Devices in AustraliaJoe Hage
http://MedicalDevicesGroup.net Sydney-based regulatory affairs expert Arthur Brandwood discusses the recent changes made by the Australian Therapeutic Goods Administration (TGA).
He also covers:
• Australia’s aggressive deregulatory agenda
• The Australian tax incentive (43.5% for R&D expenditure)
• The simple process for regulation of clinical trials in Australia
• TGA’s web based submission process for device approvals
CEO of Infinitum Humanitarian Systems Eric Rasmussen, MD, MDM, FACP helped the Medical Devices Group understand the depth of the challenges to global health.
You really have to watch his talk (some of the images will take your breath away) for the full impact of the presentation and please share it on social media and with your colleagues.
Visit http://medgroup.biz/future-global-health for the video recap and transcript and consider the 10x Medical Device Conference to meet speakers like Eric.
For 10x information, see http://medgroup.biz/About-10x
Selling Medical Devices in this Difficult Healthcare EnvironmentJoe Hage
http://medgroup.biz/meddevsales Medical Devices Group member Mike Sperduti shares the medical device selling strategies he effectively uses for GE Healthcare, Becton Dickinson, and his other medical device clients.
Mike, himself a medical device manufacturer, covers winning strategies for product launches, implementing contracts, and turning around under-performing territories.
Very well received on the live presentation. You're welcome to listen to the replay at http://medgroup.biz/meddevsales.
Global unique device identification database (gudid) and udiJoe Hage
Medical device companies are affected by the Unique Device Identification ruling from FDA. UDI experts Reed Tech help members of the Medical Devices Group understand the complexities.
You can find the audio replay and transcript at http://medgroup.biz/unique-device-identification
Roadmap to sustainable innovation for medical device manufacturersJoe Hage
How nearly 100 Medical Device Manufacturers assessed their current innovation management capabilities and how they can improve productivity, time-to-market, and commercial success.
Unique Device Identification UDI Requirements and Timelines Joe Hage
http://MedicalDevicesGroup.net Reed Technology, in collaboration with the Medical Devices Group, present information regarding the FDA's Unique Device Identifier (UDI) and discuss strategies to implement your UDI submissions solution.
An overview of the U.S. healthcare industry hiring outlook for device, medtech, and diagnostic companies grappling with increased regulation, the 2.3% device tax, ACA provisions, and a candidate-driven market.
Contemporary Medical Device Marketing for the Digital AgeJoe Hage
Medical Device Marketing can be far more robust than many in the medical device industry presently practice. For the video replay and transcript which accompany these slides, see http://MedicalDevicesGroup.net/webinar/medical-device-marketing/
FDA Audit Process Training using turtle diagrams presented by Rob Packard, founder of http://MedicalDeviceAcademy.com and Brigid Glass, CEO of Brigid Glass & Associates.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
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Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
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1. 1
Why Did the FDA Refuse Nearly 60% of
All 510(k) Submissions in 2013?
2. 2
Introductions
Rob Packard
– Founder/President, Medical Device Academy, Inc.
Carrie M. Kuehn, M.P.H., RAC
– Sr. Managing Scientist, Biomedical Engineering Practice,
Exponent
Jorge Ochoa, Ph.D., P.E.
– Principal, Biomedical Engineering Practice, Exponent
3. 3
FDA’s Refuse to Accept Policy
FDA criteria for assessing whether a 510(k) meets
minimum requirements for substantive review
Final Guidance issued December 31, 2012
Purpose:
– Focus FDA resources on review of complete 510(k)s
– Enhance consistency of acceptance decisions
– Assess completeness, not quality, of submission
FDA will respond within 15 days of receipt
4. 4
Administrative vs. Substantive Review
Administrative
Is it a device?
Are MDUFA fees paid?
Is the 510(k) the right
submission?
Presence or absence of
required 510(k) components
Results in RTA or
Substantive Review
Substantive
Quality of 510(k) components
Adequacy of submission
SE determination
Additional information
requests
Interactive review
Results in Binding
Determination of SE
“No evaluation of adequacy of content or rationale”
- Marjorie Shulman, Director 510(k) Staff, FDA
6. 6
FDA’s 2013 Annual 510(k) Performance
2,965 510(k)’s received in 2013
1,197 Accepted
1,715 Refuse to Accept
Rate of Submissions Not Accepted
58%
Quarterly Meeting on MDUFA III (FY 2013-2017) Performance. January 29, 2014
7. 7
Reported Reasons for Refusal
Failure to state whether a condom was patient contacting
Failure to explain how following the Specials Control Guidance
Document for labeling met the labeling requirements under 21 CFR
§807.87
510(k) Summary formatting comments
Failure to comply with a Draft Guidance document
Failure to indicate whether a vinyl glove contained software or met
the electrical safety requirements
Substantive questions regarding shelf-life and other content that
should be the subject of review not RTA
Typos, misprints, duplicate pages, etc.
FDA Law Blog. February 26, 2014
8. 8
More Detail Needed than Ever Before…
“We didn’t need to include that last time.”
“But that’s not applicable.”
“Do we need to provide that? It should be obvious.”
10. 10
Industry Report Card:
What the FDA Saw* 2001 - 2010
Increase in average number of review cycles from 2001
to 2010
Increase in industry time to react to questions and
deficiencies
83% of AI letters had at least one quality related
deficiency
– Inconsistencies in the submission
– Missing admin requirements
Old RTA checklist very rarely used
– Not descriptive enough
– No effect on the review clock
*Marjorie Shulman, Director 510(k) Staff, FDA. FDLI 2013
11. 11
What RTA Means to Industry
Careful what you ask for…
– Reduce number of review cycles and total time to final
decision = you get ONE shot at it
New checklist criteria
– Compilation of regulations, statutes, guidance, review
practices = addition, not intersection
– Objective tool to understand key components of complete
submission = its important to us, so its important to you
– Only evaluating presence, not adequacy, in principle
Efficient use of reviewer resources = more work on
your part
12. 12
How Are NPD Projects Affected?
If rejected: FDA clock stops and resets to day 0 when
RTA response received
RTA review is not an interactive process
Unlimited number of RTA cycles
Concept of Substantive Interaction (SI)
Missed MDUFA Decision (MMD) communication
Schedules and resources will be influenced.
Effect can be cumulative
13. 13
Training Your Resources
Make the 510(k) an integral part of your NPD work
breakdown structure
– All you need for your RTA checklist and 510(k) should be in
your DHF and project manager’s notebook
Ensure that all NPD team members and functions are
conversant in regulatory terminology and concepts
Train personnel interacting directly with FDA on
effective communication skills
– Substantive Interaction (SI) decision
– Interactive Review (IR) process
14. 14
Risk for RTA Letter
High RTA Risk
11 – Device Description
12 – Substantial Equivalence
Moderate RTA Risk
5 – 510(k) Summary or 510(k) Statement
9 – DCs & Summary Reports
10 – Executive Summary
13 – Proposed Labeling
14 – Sterilization and Shelf Life
15 – Biocompatibility
16 – Software
17 – Electromagnetic Compatibility & Electrical Safety
18, 19, & 20 – Performance Testing (Bench, Animal, Clinical)
Low RTA Risk
1 – Medical Device User Fee cover Sheet
2 – CDRH Premarket Review submission Cover Sheet
3 – 510(k) Cover Letter
4 – Indications for Use Statement
6 – Truthful and Accuracy Statement
7 – Class III Summary & Certification
8 – Financial Certification or Disclosure Statement
15. 15
Volume 9 – Declaration of Conformity (Part A)
FDA Form 3654 (http://bit.ly/Form-FDA-3654)
– Completed for all listed standards
– If two revisions are shown, only the most recent
Recommend a Summary Document
– List all Form 3654s
– List corresponding reports for each 3654
Device-specific guidance and/or special controls
– Create a table showing how each requirement is met
16. 16
Volume 12 – Substantial Equivalence (Part C)
Comparison with Predicate Device(s)
Tabular Format
Contents Include Similarities AND Differences
– Indications for use & Patient population
– Technology
– Mode of Action & Functionality
– Materials
– Size
Safety & Efficacy
http://bit.ly/Substantial-Equiv-Guidance
17. 17
Identifying A Predicate Device
513(g) Submission (http://bit.ly/513g-guidance)
Pre-Submission Meeting (http://bit.ly/FDA-Pre-Sub)
Critical Points of Comparison
– Intended Use & Patient Population
– Technology
– Mode of Action & Functionality
18. 18
Volume 11 – Device Description (Part B)
Device-specific guidance and/or special controls
Consistent with labeling
Principle of operation and mechanism of action
Conditions of use
Each device within submission
Drawings and schematics
Components and accessories—including 510(k)s
19. 19
Other Parts of RTA Checklist
Part D – Labeling (Device Specific?)
Part E – Sterilization (Novel or Non-traditional Methods?)
Part F – Shelf-Life
Part G – Biocompatibility
Part H – Software (Level of Concern & Risk Analysis)
Part I – EMC & Electrical Safety (IEC 60601-1 3rd Ed. Amd 1)
Part J – Performance Data (Special Controls?)
Part K – Performance Characteristics (IVDs only)