FDA's 510(k) Modernization: What's Changing

FDA's 510(k) Modernization:
What if anything has changed? is changing? will change?
Presented by:
Michael Drues, Ph.D.
President, Vascular Sciences
Carlsbad, California
and
Adjunct Professor of Regulatory Science, Medicine
and Biomedical Engineering
George Washington University Graduate Dept. of Regulatory Science
Cornell University Graduate Dept. of Biomedical Engineering
December 8, 2020
For questions or more information, call
(508) 887 – 9486 or e-mail mdrues@vascularsci.com
© Copyright 2020 by Vascular Sciences and Michael Drues, Ph.D. All rights reserved.

For additional information, contact Dr. Drues directly at (508) 887-9486, e-mail mdrues@vascularsci.com
or via LinkedIn at www.linkedin.com/in/michaeldrues.
© Copyright 2020 by Vascular Sciences. All rights reserved.
Speaker Biography
Michael Drues, Ph.D., is President of Vascular
Sciences, an education, training, & consulting
company offering a broad range of services to
medical device, pharmaceutical & biotechnology
companies including stimulating & innovative
educational programing, creative regulatory
strategy & completive regulatory intelligence,
regulatory submission design, FDA presentation
preparation & defense, brain-storming sessions,
prototype design, product development,
benchtop & animal testing, , clinical trial design,
reimbursement, clinical acceptance, business development & technology assessment.
Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa
State University in Ames, Iowa. He has worked for and consulted with leading medical device,
pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100
companies. He also works on a regular basis for the U.S. Food and Drug Administration
(FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and
Medicaid Services (CMS) and other regulatory and governmental agencies around the world.
Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-
edge medical technologies and regulatory affairs. He conducts seminars and short-courses
for medical device, pharmaceutical and biotechnology companies, the U.S. Food and Drug
Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers
for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies
around the world.
Finally, as an Adjunct Professor of Regulatory Science, Medicine, Biomedical Engineering &
Biotechnology, Dr. Drues teaches graduate courses in Regulatory Affairs & Clinical Trials,
Clinical Trial Design, Medical Device Regulatory Affairs & Product Development, Combination
Products, Pathophysiology, Medical Technology & Biotechnology at several universities &
medical schools on-ground & on-line.
For a comprehensive list of columns, webinar, podcasts, etc., visit,
Global Medical Device Podcast (GreenLight.Guru) here, Mike on MedTech (Medical Product
Outsourcing) here, Medical Design and Outsourcing here, Guerilla Regulatory Strategy
(MED Device Online) here and Healthcare Packaging here or LinkedIn here.
Dr. Drues can be reached at:
Vascular Sciences
2105 Twain Avenue
Carlsbad, CA 92008
Phone: (508) 887-9486
Fax: (508) 861-0205
E-mail: mdrues@vascularsci.com

1
For additional information, www.linkedin.com/in/michaeldrues,
call (508) 887-9486 or e-mail mdrues@vascularsci.com
Taken from: Designing Medical Products Seminar Serie
Copyright 2020, Michael Drues, Ph.D
GreenLight.Guru Webinar (December 08, 2020) www.greenlight.guru
© Copyright 2020 by Michael Drues, Ph.D.
and Vascular Sciences. All rights reserved.
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Vascular Sciences
510k Modernization:
presented by:
Michael Drues, Ph.D.
President, Vascular Sciences, Carlsbad, California
and
Adjunct Professor of Regulatory Science, Medicine and Biomedical Engineering
George Washington University Graduate Dept. of Regulatory Science
Cornell University Graduate Dept. of Biomedical Engineering
For questions or more information, contact me at
(508) 887 – 9486 or mdrues@vascularsci.com
Join me on LinkedIn at www.linkedin.com
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Vascular Sciences
510k Modernization:
Do you want more?
For columns, articles and podcasts… visit www.VascularSci.com
Global Med Dev Podcast (GreenLight.Guru) here
Mike on MedTech (Medical Product Outsourcing) here
Medical Design and Outsourcing here
Guerilla Regulatory Strategy (MED Device Online) here
Healthcare Packaging here
LinkedIn here
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Vascular Sciences
510k Modernization:
What is 510k modernization and why now?
FDA Press Release: FDA continues to take steps to fulfill its commitment to strengthen and modernize the 510(k) medical device program
(Sept, 2019) here.
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Vascular Sciences
510k Modernization:
An exception to the rule?
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Vascular Sciences
510k Modernization:
What's the root
cause of 510k
modernization?
RAPS: 510(k) Modernization: FDA Floats Need to Pursue New Authority here.
Could it be politics?
CDRH goal (Jan, 2018): have 50% of “novel devices” come to the
US first or in parallel with other major markets.
Questions:
What does “novel” mean? i.e., does PMA or HDE necessarily mean novel?
Can a 510k device be “novel” if its SE to something else?
Does “Breakthrough 510k” = Oxymoron ?
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Vascular Sciences
510k Modernization:
What’s your regulatory advice?
Very simple:
Design your device (labeling + technology) to be as
similar as possible (i.e., identical?) to your predicate!
Does this “encourage” copying? – Absolutely! 
Is that the academic equivalent of plagiarism? – Yep, but its reality! 
What’s the alternative?
De novo!
Reminder: Don’t use regulation or FDA as an excuse to hold you back!
If your goal is to mitigate regulatory burden (i.e., minimize time to market, cost, risk, etc.)…
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Vascular Sciences
510k Modernization:
Guest Editorial:
The de novo
pathway -
Strategies and
Tactics to Use
and Avoid
http://www.globalregulatorypress.com/
The De Novo Pathway (J Med Dev Reg, May, 2015)
Abstract available here.
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Vascular Sciences
510k Modernization:
Want
more?
Webinar + Handout (Dec 7, 2017) available here
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Vascular Sciences
510k Modernization:
Does the 510k
encourage innovation or
me-too’s?
Before answering, consider this: What’s the difference between
Evolutionary vs. Revolutionary Product Development?
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Vascular Sciences
510k Modernization:
Want more?
https://www.greenlight.guru/blog/fda-plans-to-modernize-510k (December, 2018)
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Vascular Sciences
510k Modernization:
Let's dig deeper…
https://www.greenlight.guru/blog/fda-plans-to-modernize-510k
(December, 2018)
Highlights:
✓ Root cause #1: news of devices gone bad and the challenge of predicate creep [Bleeding Edge]
✓ Root cause #2: FDA wants manufacturers to develop newer and better technologies than
what’s currently available. – should “better” be a part of a 510(k)? an oxymoron?
✓ 10-Year Predicate Rule: can’t use predicate > 10 years old – will this solve problems or
create more problems?
✓ 510k 101: successful 510k needs a predicate – no limitation on age nor on how similar
✓ Interpretation: If new device increases or creates new risks than a predicate, can’t be a
510(k) - but this is not usually enforced and de novos are sometimes pursued. Up to
medical device professional to decide which predicate would be the best to use - no
matter if it’s 1, 10, or 40 years old.
✓ 20% of 510(k)s reference predicate > 10 years old – a solution for 20% not 80%?
✓ There’s been past movements for alternative and abbreviated 510(k) pathways. So, nothing
really new or revolutionary with FDA’s statement. – safety and performance based 510k
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Vascular Sciences
510k Modernization:
Public Perception
Article: New Documentary Film Is Scathing Indictment Of FDA's Regulation Of Medical Devices (Forbes, July 29, 2018) here or attached
Video: The Bleeding Edge Trailer on Netflix or YouTube
Video: We are guinea pigs: Filmmakers on the risks of medical devices (CBS News, July 27, 2018) on CBS or YouTube
Bleeding Edge Trailer (Netflix) (2 min)
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Vascular Sciences
510k Modernization:
Implant Files
Implant Files Video: here Home Page here.
The regulatory ancestral network of surgical meshes here.
Implant Files (3 min)
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Vascular Sciences
510k Modernization:
What types of 510k’s exist
and don’t exist… yet.
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Vascular Sciences
510k Modernization:
Types of 510k’s
✓ Traditional
✓ Special
✓ Abbreviated
Note:
The “New 510k Paradigm” is 20 years old!
Do we need anything else?
✓ Safety and Performance 510k
Created in 2018 but what is it?
The Safety and Performance Based 510(k): A New Pathway for Regulatory
Submission (Med Device On-line, March, 2019) here.
✓ Catch-Up 510k
Still doesn’t exist… formally. What is it?
✓ Anything else?
The New 510(k) Paradigm - Alternate Approaches to
Demonstrating Substantial Equivalence in Premarket
Notifications (CDRH "Final" Guidance, March, 1998) here.
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Vascular Sciences
510k Modernization:
“New” Safety and Performance 510k
Safety and Performance Based Pathway (Feb, 2019) here.
Is the “new” sp510k2018 substantially equivalent to a510k1998?
Pun intended! ☺
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Vascular Sciences
510k Modernization:
Catch-Up 510k
✓ What is a catch-up 510k?
Hint: Medical device development is often an iterative process (unlike drugs)!
✓ Why do we need it?
Hint: What is change creep?
✓ When should we use it?
Hint: before or after getting a 483? maybe even a warning letter?
✓ Given there is no catch-up 510k, how would you use it?
Hint: Don’t use regulation as an excuse to hold you back!
Reference: “The “Catch-Up” 510(k) — A Submission Often Overlooked” (RAPS, Jan, 2016) here.
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Vascular Sciences
510k Modernization:
Do we need more
regulation OR
Do we need to better
understand & apply the
regulation we already have
What are the requirements of a successful 510k?
Two most important components + Governing Equation
Reminder:
Regulation is all about the interpretation of words…
and your ability to defend your interpretation!
and why assume FDA’s interpretation is the only one or the best one???
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Vascular Sciences
510k Modernization:
What are the two most
important components of
a successful 510k
Substantial Equivalence Argument
and Risk Mitigation Strategy
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Vascular Sciences
510k Modernization:
Is there a Governing Equation of the 510k?
Two fundamental equations of the 510k are:
1) 510k = SE + Risk
and
2) SE = Labeling + Technology
To simplify, combining 1) and 2) gives the Governing Equation of the 510k:
510k = (LabelingSE + TechnologySE) + Risk
Note: Risk = RiskBucket1 + RiskBucket2 + RiskBucket3
Simply put, any successful 510k has to solve the equation above i.e.,
valid and defensible solution → 510k
no, invalid or indefensible solution → de novo, PMA…
In other words…
Don’t focus on what the regulation says – focus instead on
understanding the regulatory logic, i.e., thinking process,
which is infinitely more important than regulation!
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Vascular Sciences
510k Modernization:
Greenlight
www.greenlight.guru/webinar/510k-substantial-equivalence
More on Substantial Equivalence…
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Vascular Sciences
510k Modernization:
More on
Risk
March, 2017
www.greenlight.guru/
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Vascular Sciences
510k Modernization:
What happens when you
get substantial
equivalence wrong
Usually nothing good… i.e.,
more time, more money, more rigorous pathway to market
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Vascular Sciences
510k Modernization:
Does NSE necessarily mean NSE?
What if my device is deemed NSE from FDA (here):
A [regulated] device may not be marketed in the U.S. until the submitter receives a letter
declaring the device substantially equivalent. If FDA determines that a device is not
substantially equivalent [NSE], the applicant may:
• resubmit another 510(k) with new data,
…not my recommendation, at least not yet!
• request a Class I or II designation through the De Novo Classification process
…this could have been avoided long ago!
• file a reclassification petition, or
• submit a premarket approval application (PMA).
…you have made a huge mistake and could have been avoided long ago!
Bottom line:
Not guilty does not necessarily mean innocent…
NSE does not necessarily mean NSE!
But remember…
An NSE should never happen… but it does – A LOT!
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Vascular Sciences
510k Modernization:
What is the Achilles Heal
of the 510k
Short answer: Predicate Creep
What is predicate creep?
What's the solution?
Why is the 10-year predicate rule so attractive to so many?
Maybe because it requires no thinking! But is that what we want?
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Vascular Sciences
510k Modernization:
What is engineering creep?
• in materials science, creep (or deformation) is the tendency of a solid material to slowly
deform permanently under the influence of stress (i.e., pulling)
• occurs as a result of long term exposure to high levels of stress and at higher temperatures
and/or prolonged periods of time.
• incremental device changes that seem innocuous individually in one 510(k) submission,
may accumulate over time to create a device that is significantly different from the original
device leading to ‘predicate creep’
Do you see any similarities?
Similar to ‘non-inferiority creep’
• when a series of non-inferiority studies is conducted over time
• for example, device B is non-inferior to A, device C is non-inferior to B, and device D is
non-inferior to C), but the difference in effectiveness between device A and D may
approach clinical significance
Similar to ‘endpoint creep’
• adding additional clinical endpoints to study design (usually added as an amendment, i.e.,
after the fact… very expensive!)
So is there a test for predicate creep? or non-inferiority creep?
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Vascular Sciences
510k Modernization:
Predicate Creep
At what point do small/incremental changes become significant?
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Vascular Sciences
510k Modernization:
Remember the movie…
How does it apply here?
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Vascular Sciences
510k Modernization:
Want to know the “truth” about the 510k?
The 510k (Last Week Tonight with John Oliver, HBO, Jun 3, 2019) (20 min) here or
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Vascular Sciences
510k Modernization:
Do we need to change
(modernize?) the 510k
Short answer:
Absolutely!
Better question: How do we change (modernize?) the 510k?
More regulation vs. More thinking and More Responsibility
Something to think about!
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Vascular Sciences
510k Modernization:
Is it possible to think regulatory?
“Regulatory affairs is a way of
thinking much more than it is a body
of rules and regulations – or at least
it should be!”
Michael Drues (1964–)
Regulatory Strategist and Amateur Philosopher ☺
www.meddeviceonline.com/author/michael-drues
“Science is a way of thinking much
more than it is a body of knowledge.”
Carl Sagan (1934–1996)
American astronomer, author and science journalist
So how about this?
Maybe Carl Sagan would be proud!
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Vascular Sciences
510k Modernization:
Don’t just follow the
rules… think!
Rules are mostly made to be broken
and are too often for the lazy to hide behind.
General Douglas MacArthur (1880 –1964) was an American general in the US Army during the
1930s and played a prominent role in the Pacific theater during World War II. He was one of only
five men ever to rise to the rank of General of the Army in the U.S.
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Vascular Sciences
510k Modernization:
There are many regulatory consultants out there…
but there are surprisingly few good ones!
So how do you become a good one?
Learn when to follow and
more importantly…
when to lead!
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