Welcome to the webinar

Mastering your 510(k)

submission process

Kyle Rose & Kelly Stanton

Before we get started

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Today’s agenda

01 What is 510(k)?

02 The process

03 Top tips and mistakes to avoid

Today’s hosts

Kyle Rose Kelly Stanton

President Director of Quality
Rook Quality Systems Qualio
What is Qualio?

The #1 cloud-based quality management

system for life science companies

Easy to use Scales with you Fast set-up

Customer commitment Connected ecosystem

What is 510(k)?
Three risk classifications
Your 510(k) submission should…

Demonstrate your Class II device is ‘substantially equivalent’

to a predicate already on the market

House detailed technical, safety and performance

device/test information

Prove a robust quality and risk management system

What is a predicate device?

Same intended use as your device

Similar technology to that involved in the function and

operation of your device

Same level of safety and efficacy as your device

Who needs to submit a 510(k)?

Medical
device
manufacturers

Repackers or
relabellers
Specification (in the event of
developers a significant
process
change)

Representatives
of non-US
manufacturers
The process
1. Your device and its predicate
Ensure you’re Class II
What type of 510(k)?

Traditional Special Abbreviated

New device, Change to already-cleared device Showing substantial equivalence to

never cleared before OR device that doesn’t require extra V&V a recognized standard, special
undergoing significant change performance data control or guidance rather than a
predicate device
Find your predicate
Don’t overthink it – just Google!

Find an existing business and device and compare:

● Intended use
● Design
● Materials
● Safety
● Labeling
● Performance considerations: engineering,
sterility, compatibility, software validation, etc.

Head to the FDA’s 510(k) database

Official guidance for determining
substantial equivalence:

fda.gov/media/82395/download
Predicate shopping list
● 510(k) submission summary
● A sample (probably lots of samples…)
● Diagrams
● Operating instructions
● Labels
● Marketing literature
2. Quality system
Create a medical device QMS!
Medical device QMS ingredients

● Regulatory compliance strategy

● General safety and performance requirements
● Management responsibility
● Resource management
● Risk management
● Clinical evaluation
● Product realization
● Unique Device Identification
● Post-market surveillance system
● Communication with competent authorities
● Incident reporting & field safety corrective action
● CAPA management
● Monitoring & measurement
Document now to make your submission easy later
Research Early development Late development Lifecycle

Basic research

Prototype design
& discovery
Pre-clinical
development
Concept feasibility &
Design & development planning
evaluation
Device User needs/ Design
development design inputs verification

Design-build-test-refine Design transfer

Design Design
outputs validation
Regulatory
DEVICE FUNCTIONALITY & INTERACTION filing

USER INTERFACE: HUMAN FACTOR STUDIES Launch

DESIGN CONTROLS/RISK MANAGEMENT Post-market

3. Testing
What tests do you need?
● Use your predicate device
to determine your exact Wear,
testing pathway fatigue &
Biocompatibility/
electromagnetic
durability FCA/FMEA/
● Typical examples: compatibility FMECA

Mechanical/ Materials &

thermal/ make-up
electrical

Feature
performance
(normal + Cleaning/
abnormal
conditions)
sterilization
Testing tips

1 Use the product claims of your

predicate to set your test criteria

2 Use ISO 14971 as your benchmark

Look for historical recalls in your

3 product code category - use the faults
as inspiration

4 Give yourself a digital mechanism for

recording your design control activity
Budget wisely…
Testing activity will form the bulk of your 510(k) expenses

Get the right people and tools to maximize your in-house capability:
● Third-party biocompatibility testing: $13,000
● Third-party sterilization testing: $15,000
● Third-party bench testing: $30,000
● Third-party electrical/EMC testing: $50,000
● Third-party implantation testing: $100,000+

An SaMD requires software validation activity too

4. Submission
Twenty is plenty

Cover sheets Summary Statements

● FDA 3601 form ● Cover letter ● Truthful & accurate

● FDA 3514 form ● Statement of statement
indications for use ● Class III summary
● 510(k) summary ● Financial
OR statement certification/
disclosure statement
● Declaration of
conformity &
summary reports
Twenty is plenty

Substantial equivalence Safety

● Executive summary ● Proposed labeling

● Device description ● Sterilization & shelf life
● SE comparison ● Biocompatibility

Digital/electrical Performance

● Software ● Bench
● Electromagnetic compatibility/ ● Animal
electrical safety ● Clinical
Cover sheets

Medical Device User Fee Cover Sheet

FDA 3601 form

FDA 3514 form

CDRH Premarket Review Submission Cover Sheet

Save $14,903 with a form
Make less than $100m annually?

Complete FDA Form 3602 (or 3602A for non-US firms) to register as a small business.

Complete every year to maintain small business status!

510(k) standard 2023 fee 510(k) small business 2023 fee

$19,870 $4,967

+ Annual establishment registration fee: $6,493

Summary documents

Broad summary of your submission

Cover letter MUST match indications for use of your predicate. Made
public after 30 days – so don’t reveal too much if your
device is designed to fill a market niche!
Statement of
indications for use
Choose ONE:
● Summary: combination of information that your SE claim
510(k) summary is based on
OR statement ● Statement: Certification that you’ll provide
safety/effectiveness information to any requester within
30 days
Statement documents
I certify that, in my capacity as (the position held in company)
of (company name), I believe to the best of my knowledge,
that all data and information submitted in the premarket
Truthful & accurate notification are truthful and accurate and that no material fact
statement has been omitted. (Signature, date, time)

Class III summary As we’ve seen, most 510(k)s are for Class IIs - so this is a
simple declaration that you aren’t a Class III device. If you are,
Financial certification/ you’ll need extra safety/effectiveness data here in line with
disclosure statement your device’s higher risk profile

Only applies if clinical trials have taken place.

Declaration of
Paid your investigators? Disclosure statement
conformity & summary
Didn’t pay them? Financial certification
reports
Not mandatory for the traditional route. For showing
conformity with relevant standards in the abbreviated route
SE documents

More detailed version of the 510(k) summary, elaborating

Executive on your completed testing activity
summary
Design History File, design outputs, drawings, specs,
Device description dimensions, etc.

SE comparison Side-by-side mapping of your device and its predicate:

use, technology, performance
Safety documents

Device label, patient labeling, in-package inserts, operating

Proposed labeling instructions

Sterilization & Include test data for these areas here if applicable
shelf life

Biocompatibility Include test protocols and reports for any areas in patient
contact (direct or indirect)
Digital/electrical documents
If relevant, establish your Level of Concern (LOC) and add
your test data accordingly

(Refer to ‘Guidance for the Content of Premarket

Submissions for Software Contained in Medical Devices’ and
IEC 62304 for help)
Software
EMC: proving your device won’t interfere with, or be
Electromagnetic jeopardized by, other nearby devices
compatibility/
electrical safety (Use IEC 60601-1 for help)

Electrical safety: proving electrical components in patient

contact aren’t a threat to patient safety

(Use IEC 60601-2 for help)

Briefly explain why
Section 16 doesn’t
apply to you

Don’t neglect
Section 16 if your
device sits here!
Performance documents

Bench Only bench testing is mandatory.

Animal All completed tests should have protocol

descriptions, summaries, methodologies and clear
results
Clinical
Don’t forget the RTA checklist
● Before submission, review the FDA’s
refuse-to-accept (RTA) checklist to make sure
you’re fulfilling all of its 56 requirements

● Ignore the checklist at your peril!

● Any breach of the checklist will trigger a

refuse-to-accept letter from the FDA
Process updates in 2022: the e-510(k)!
- The submission process was more heavily digitized in 2021 (progress tracker) and 2022
(electronic upload trial)

- Following early success, in October 2022 the FDA announced its CDRH Customer
Collaboration Portal would allow either an electronic copy (eCopy) or electronic
Submission Template And Resource (eSTAR) 510(k) submission
Prepare to go digital
- The Electronic Submission Template was launched in September 2022

- From October 1, 2023, all 510(k) submissions must be submitted as an eSTAR

- Only limited exemptions apply for:

- Interactive review responses

- Amendments
- Appeals/requests for supervisory review
- Substantive summary requests
- Change in correspondent amendments
- Amendments after final decision (such as add-to-files)
5. The wait!
Despite the ‘ideal’ 100-day
timeframe, the average
approval time after
submission is:

175 days
This is skewed by some
excessively long device
approvals however, with the
median approval time
standing at:

85 days
Congratulations: you’re approved cleared!
- You’ll receive a letter (no certificate)

- You can now market your device, but must still comply with other requirements like:

- Registration and listing (21 CFR Part 807)

- Labeling (21 CFR Part 801)
- Reporting (21 CFR 803)
- GMP requirements (21 CFR Part 820)

- Pour yourself a drink. But remember, this is the beginning not the end!
Top tips and mistakes to avoid
30% of 510(k) submissions last year
weren’t even accepted for initial review.

A right-first-time 510(k) approach gets

you to market faster, eliminating wasted
time and effort while generating revenue
more quickly.
Top 510(k) mistakes

1 Incorrect template documents or document

versions 5 Incomplete test information (summaries without
protocols/reports)

2 Wrong predicate (!) 6 Wasting money by not applying for small business
status

3 Inconsistent information in areas where

information is repeated in the submission 7 Immature quality/risk management

4 Skipping non-applicable sections, instead of

documenting why they aren’t applicable 8 Generally disorganized submission docs (no ToC,
lax sectioning/numbering, etc.)
Top tips

1 Try and use a fairly recent device as a predicate. Devices older than a decade are frowned upon

Ensure everything is covered - nearly two-thirds of submissions are slowed by Additional

2 Information (AI) requests

3 The more design control, risk and quality documentation you can organically build as you develop
your device, the faster and easier your 510(k) assembly will be

4 Substantial equivalence is everything! 15% of submissions fail because of the wrong predicate

5 Familiarize yourself with the eSTAR now, so you’re prepared for the October 2023 transition date
Q&A
Thank you!