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1. FDA Approval for Medical Devices:
A Guide for Entrepreneurs
Jim Gustafson, Expert in Residence
UCI Applied Innovation
Friday 21 April 2017

2. Today’s
Outline
1. Our Purpose
2. Who Am I?
3. Basics of Device Regulation in the US
4. Developing a Regulatory Strategy
5. Final Thoughts
6. Questions

3. 1. Our Purpose

4. What Do
Potential Investors
Want to Know?
 What is your approval pathway?
 How long will it take?
 How much will it cost?
 How likely is success?

5. Without A Viable Strategy
for Regulatory Approval,
You Will
 Investors will dismiss you.
 FDA will be a roadblock to you.
 Employees will lose faith in you.
 Potential customers will find
someone else to meet their needs.

6. Today’s Objectives
Provide a basic scaffold to better
understand the regulatory realities
and options for your own situation.
Not to answer all your questions or define a
reg strategy for you. A reg strategy must be
custom-fit to your product, business plan,
customer, competitive landscape, etc.

8. Academics
BS Biology 1977
University of Minnesota
MS Biology 1978
University of California, Irvine
MA Management 1986
University of Redlands
Mini-MBA 2011
Carnegie-Mellon University, Pittsburgh

9. Professional
 35+ years in the medical device industry
• Class II and III
• Regulatory Strat, Clin Science, Executive
• 40-plus 510(k)s, PMAs, PMAS, IDEs, CE Marks
• 3 FDA Advisory Panel presentations
• 20-plus multi-center clinical trials in NA and EU
 Last Company: from pre-sales and no approvals to $80M
sales and 20 approvals. In 14 yrs. Sold in 2008 for $361 M.
 Last Title: SVP, Clinical Science and Regulatory Affairs
 Now: Semi-retired indy consultant to med device cos.
• EiR with UCI Applied Innovations
• OCTANe panelist and LauchPad consultant
• Undergrad Mentor, UCI Ayala School of BioSci

10. 3. Basics of Medical Device
Regulation in the US

11. The Law Requires
• US Medical Devices must be proven
“safe and effective” based on “valid
scientific evidence”.
• Compare to US Drugs: must be proven
“safe and effective” based on “well-
controlled clinical studies”.
• Compare to Devices in the EU: must be
proven “safe and functions as designed”.

12. Medical Devices are
Regulated Based on Risk
Class Requirements
I 1. General Controls
II
1. General Controls
2. Device-Specific Special Controls
3. Premarket Notification, aka 510(k)
III
1. General Controls
2. Device-Specific Special Controls
3. Premarket Approval, aka PMA

13. Medical Devices are Regulated
Based on Device Risk
Class Requirements
I 1. General Controls
II
1. General Controls
2. Device-Specific Special Controls
3. Premarket Notification, aka 510(k)
III
1. General Controls
2. Device-Specific Special Controls
3. Premarket Approval, aka PMA

14. General Controls
• Adulteration
• Misbranding
• Device registration and listing
• Records and reports
• Good Manufacturing Practices (GMPs,
aka Quality System Regulation, or QSR)

15. Medical Devices are Regulated
Based on Device Risk
Class Requirements
I 1. General Controls
II
1. General Controls
2. Device-Specific Special Controls
3. Premarket Notification, AKA 510(k)
III
1. General Controls
2. Device-Specific Special Controls
3. Premarket Approval, AKA PMA

16. Special Controls Include
 Independent Standards:
 ISO, ANSI, IEC, ASTM, etc.
 Horizontal Standards
 Vertical Standards
 FDA Guidance Documents
If any of these apply to your product,
use them, or be prepared to explain why not,
and what you used instead, and why.

17. 4. How to Develop a
Successful Regulatory
Approval Strategy

18. At some point you should
probably talk to your
friendly neighborhood
regulatory consultant.
But you can figure out many
of the key elements yourself!

19. How? Ask the
Right Questions!
1. Is my product a medical device?
2. What Class is my product in?
3. What is my pathway to approval?
4. Will clinical studies be needed?
5. What are the strategic implications
of the pathway?

20. Is My Product a
Medical Device?
An instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related article,
component, or accessory which is:
1. Intended to diagnosis disease or other conditions; or
2. Intended to cure, mitigate, treat, or prevent disease; or
3. Intended to affect the structure or any function of the body;
4. And which does not achieve any of its primary intended
purposes through chemical action,
5. And does not depend on being metabolized to achieve them.

21. The Border May
be Set by Claims
and Intended Use
Example: A wearable that counts footsteps or
calories, but claims no medical benefit from doing
so, is NOT a medical device.
The same product doing the same thing but with
the claim that doing so helps the user lose weight
or lower blood pressure IS a medical device.

22. What Class is
My Product?
• Go to FDA > Medical Devices >
Data Bases > Product Classification
(https://www.accessdata.fda.gov/scripts/cdrh/cf
docs/cfPCD/PCDSimpleSearch.cfm)
• Type in the name of your product.
• Review the listing.
• Iterate until you find the most accurate
description.

23. Product Classification Page

24. Example: Drug Eluting Stent

25. Example: Surgical Scissors

26. Example: IVUS Catheter

28. What Is My
Approval Pathway?
Class Level of Proof FDA Filing*
Testing
Needed*
I
Mfg Registration
and Device Listing
Bench
II
Substantial
Equivalence
510(k)
Bench
Animal
III Safe and Effective PMA
Bench
Animal
Human
*Some Exceptions

29. Is My Device a 510(k)?
Almost all Class II devices are! But how to know?
• Check out similar devices on the FDA Product
Listing page
• Find 510(k)s for similar devices at FDA >
Medical Devices > Database > 510(k)s
• Is there a device, itself under 510(k), to which
you can prove substantial equivalence (SE)?
• You can’t claim SE to a PMA device.

30. What Makes for SE? (1/2)
Compared to the Proposed Predicate Device:
• Same intended use and same technological
characteristics; or
• Same intended use and different technological
characteristics, but that do not raise new
questions of safety and effectiveness, with
supporting evidence that the new device is at
least as safe and effective as the predicate.

31. What Makes for SE? (2/2)
SE does not mean the 2 devices are
identical. SE is judged base on intended
use, design, energy used or delivered,
materials, chemical composition,
manufacturing process, performance,
safety, effectiveness, labeling,
biocompatibility, standards, etc.

32. SE is Kind of
a Black Art
• The closer to your proposed predicate on each
of these, the more likely you will succeed.
• But there is no hard rule, guidance!
• FDA will not tell you; you must make your case
in a 510(k) filing!
• In FDA’s response, you will know.
• One key: how far is your predicate from its?
SE

33. If Not 510(k), Then It’s PMA
Class Level of Proof FDA Filing*
Testing
Needed*
I
Mfg Registration
and Device Listing
Bench
II
Substantial
Equivalence
510(k)
Bench
Animal
III Safe and Effective PMA
Bench
Animal
Human
*Some Exceptions

34. PreMarket
Approval
• Must prove the device is safe and effective
• IDE clinical trials needed
• Are your nearest competitor devices
PMAs? Check at FDA > Medical Devices >
Databases > PMAs

35. Will I Need
Clinical Studies?
• All original PMAs need
clinical studies
• And 10% of all 510(k)s
also need clinical studies
• Conducted under IDE
• Add multiple $$Mi and
years to market!

36. What are the Strategic
Implications?
Class
Level of
Proof
FDA
Filing*
Size of the
Filing
Fees:
“Retail”
Small Bus
Time**:
to Reply
Total Time
N per
Year**
Changes
After
Approval?
I
Mfg Registration
and Device Listing
10-20 pp $3,382 2-4 weeks NA
Update device
listing
II
Substantial
Equivalence
510(k) 50-200 pp
$4,690
$2,345
3 months
7 months
3,060 File new 510(k)
III
Safe and
Effective
PMA
10,000–
50,000 pp
$234,495
$58,624
6 months
16 months
45
File PMA
Supplement
(2,116/y)
*Exceptions **For 2016

37. Final Thoughts

38. Don’t Make These Mistakes!
 “My device has patents, so it can’t be SE”.
 Design your device, get investors, and THEN
get a regulatory strategy.
 Use mfgs inexperienced with FDA.
 Plan for a large % of your sales to be off-label.
 Hide from FDA until you file your submission.
 “I paid the filing fee; FDA owes me approval!”
 Expect FDA to tell you what to do.
 Think that FDA market approval/clearance
assures 3rd party reimbursement.

39. Regulatory
Wisdom (?)
 The product you submit on is far more than the device you design.
 Remember the two key regulatory approval questions:
 Is it 510(k) or PMA?
 Are clinical trials needed?
 About FDA, remember:
 Attitude: process-driven and professional. Every device is
unsafe and ineffective until proven otherwise.
 Mission: safe and effective medical devices. Not cool, disruptive,
or cheap. They don’t care about your business success.
 Regulatory applications are written by believers and reviewed by
skeptics.

41. Questions!