How to prepare a 510(k) Submission for the FDA June 4, 2015

Transcription

Slide 1 of 35
How to prepare a 510(k)
Submission for the FDA
June 4, 2015
Rob Packard, President
www.MedicalDeviceAcademy.com
rob@13485cert.com
Slide 2 of 35
Agenda
•
•
•
•
•
•
•
Introduction
Step-by-Step Predicate Selection
Strategic Considerations
When You Can’t Identify a Predicate Device
Substantial Equivalence & New Flow Chart
510(k) Project Management
Q&A
rob@13485cert.com
Slide 3 of 35
510(k) Target Timeline
rob@13485cert.com
Slide 4 of 35
RTA Checklist
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedoc
uments/ucm315014.pdf
4
rob@13485cert.com
Slide 5 of 35
Acceptance Review &
RTA Common Issues
Top 15 Mistakes
Criteria #
28 – shelf life
9 – prior submissions
36 – performance data
4a – 510(k) summary
17a - labeling
26 – expiration date
30 - biocompatibility
16–comparison to predicate
29 - biocompatibility
if 8 – Form 3654
18 – prescription use
12- engineering drawings
31- biocompatibility
R 13c- components/accessory
14. 15a - comparison to
predicate
Rate
54%
47%
33%
32%
32%
32%
30%
29%
29%
28%
22%
21%
21%
20%
• Results in 1 of 3 paths w/in 15 days of receipt:
•
– 510(k) is accepted for substantive review or
– 510(k) isn’t accepted for review = RTA or
– 510(k) is under substantive review FDA didn’t
complete acceptance review w/in 15 days
(Does not happen often, if at all)
Rate of submissions not accepted (based on RTA)
– FY 2013 – 58%; FY 2014 – 56%
20%
7
5
rob@13485cert.com
Slide 6 of 35
Product Classification
http://medicaldeviceacademy.com/fda-device-classification/
1. Identify a device similar to yours
2. Use the registration and listing database
http://bit.ly/CDRH-Registration-Listing-Database
3. Identify the 3-letter product code
4. Click on the code to go to the product
classification page
5. Click on the TPLC link http://bit.ly/FDATPLC
rob@13485cert.com
Slide 7 of 35
Find Classification Other Ways
http://bit.ly/ProductClassification
rob@13485cert.com
Slide 8 of 35
Case Study Example #1
• Topical skin adhesive
• Special controls guidance
• Multiple predicates to choose within the MPN
product code
http://medicaldeviceacademy.com/510k-submission-fda-case-study/
rob@13485cert.com
Slide 9 of 35
Case Study Example #2
• Pedicle Screw Spinal System, Adolescent
Idiopathic Scoliosis
• Specific Labeling Requirements
• 90 predicates to choose within the OSH product
code, but most people only find 3
http://medicaldeviceacademy.com/indications-for-use-case-study/
rob@13485cert.com
Slide 10 of 35
Strategic Considerations
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•
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Is It Legally Marketed
History of Adverse Events
Intended Use Breadth
Technological Characteristics & Associated Risks
Version 1.0, 2.0, 3.0…
rob@13485cert.com
Slide 11 of 35
Version 1.0, 2.0, 3.0…
•
•
•
•
Establish History of Company with FDA
Many Small Leaps of Logic vs. One Big Leap
Clinical Studies in Parallel with 1st Submission
Earlier Cash Flow
rob@13485cert.com
Slide 12 of 35
When You Can’t Identify a Predicate
1.
2.
3.
4.
5.
Clinical Study & PMA
De Novo Submission
510(k) Submission
Pre-Sub Meeting
513(g) Submission
rob@13485cert.com
Slide 13 of 35
Most Critical Sections
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•
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4 – Indications for Use (1st)
5 - 510(k) Summary (4th)
10 – Executive Summary (my last)
11 - Device Description (2nd)
12 – Substantial Equivalence (3rd)
• RTA Checklist is a great quality

rob@13485cert.com
Slide 14 of 35
How FDA Evaluates SE?
http://bit.ly/Substantial-Equiv-Guidance
rob@13485cert.com
Slide 15 of 35
Predicate Selection
1. Is the predicate device legally marketed?
2. Do the devices have the same intended use?
3. Do the devices have the same technological
characteristics?
4. Do the different technological characteristics raise
different questions of safety and effectiveness?
5. Are the methods of evaluating new/different
characteristics acceptable?
6. Does the data demonstrate substantial
equivalence?
rob@13485cert.com
Slide 16 of 35
Legally Marketed?
Registration and listing database
http://bit.ly/CDRH-Registration-Listing-Database
A 510(k) is not enough!
rob@13485cert.com
Slide 17 of 35
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
rob@13485cert.com
Slide 18 of 35
Split Predicates
• 1st Predicate has same intended use
• 2nd Predicate has same technological
characteristics
This is not allowed.
rob@13485cert.com
Slide 19 of 35
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
• Options 3:
– More than one indication under the same intended
use
rob@13485cert.com
Slide 20 of 35
Examples
• Example 1 – Hemodialysis catheter
– Predicate A has same extension design
– Predicate B has same tip design
– Both A & B predicates have the same intended use
• Example 2 – Fracture fixation plate
– Predicate A is indicated for middle bone fractures
– Predicate B is indicated for bone tip fractures
– Both A & B predicates are intended for long bone
fractures
– New performance testing may be required
rob@13485cert.com
Slide 21 of 35
Examples (continued)
• Example 3 – 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, excision, ablation, vaporization of
soft tissue.”
– 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.
rob@13485cert.com
Slide 22 of 35
• Example 4 – Multi-parameter monitor
– New monitor includes different technologies
– Predicate for each parameter
– Monitoring of each parameter cannot interfere with
the others
rob@13485cert.com
Slide 23 of 35
• Example 5 – Temperature measuring urinary
catheter
– Urinary catheter is primary predicate
– Thermometer is secondary predicate added as a
convenience
– Two predicates fall under different classifications
– The additional feature cannot alter the risk profile of
the urinary catheter
rob@13485cert.com
Slide 24 of 35
Equivalence Data
• Intended Use
• Technological Characteristics
– Materials, Design, Energy Source, Other Features
• Performance Data
–
–
–
–
–
–
Biocompatibility
Electrical Safety & Electromagnetic compatibility (EMC)
Software verification and validation
Mechanical and acoustic testing
Animal Study
Clinical Study
rob@13485cert.com
Slide 25 of 35
Section 2 - Table of Contents
• 20 Sections
http://bit.ly/510k-Format
• Create a Template (http://bit.ly/510k-ToC)
• eCopy Guidance (http://bit.ly/FDA-eCopy)
• RTA Checklist (http://bit.ly/Acceptance-Checklist)
rob@13485cert.com
Slide 26 of 35
Use ToC as Planning Tool
• red = the information does not appear to be
available
• yellow = document requires revision and/or
reformatting of content
• blue = ready for the client’s review and approval
• green = ready for submission
• Add a column to assign team responsibilities
• Prioritize task completion
rob@13485cert.com
Slide 27 of 35
Example of ToC Tool
http://medicaldeviceacademy.com/510k-submission-fda-case-study/
Section #
1
2
3
Description of 510(k) Section
Medical Device User Fee Cover Sheet (Form FDA 3601)
Table of Contents
510(k) Cover Letter & CDRH Premarket Review
Submission Cover Sheet
4
Indications for Use Statement
5
6
7
8
510(k) Summary or 510(k) Statement
Truthful and Accuracy Statement
Class III Summary and Certification
Financial Certification or Disclosure Statement
9
10
Declarations of Conformity and Summary Reports
Executive Summary
11
Device Description
12
Substantial Equivalence Discussion
13
14
15
16
17
Proposed Labeling
Sterilization and Shelf Life
Biocompatibility
Software
Electromagnetic Compatibility and Electrical Safety
18
19
20
21
Performance Testing – Bench
Performance Testing – Animal
Performance Testing – Clinical
Other
Comments
Missing
Missing
May want to add a confidentiality statement and
need to include coverletter
Does not match the predicate - is this more
narrow or just different
You have both and only need one; there is a new
guidance for 510k summary
ok - must be signed
need to explain why it's not applicable
Need all the form 3654s completed for each
applicable standard and a summary document-ideally in tabular format
Need to review in detail, but looks good
You might want these to be documents
referenced rather than embedded figures
Needs lots of work to comply with current
guidance - July 24, 2014
Needs to include PDF of labels and IFU; IFU
needs to include indications for use and it must
match Section 4 exactly
Missing
Missing
Missing - should include simulated use--maybe
with an anotomical "dummy"
N/A
Assigned To
Client
Rob Packard
Target Completion Date
Client
Rob Packard
Client
Client
Rob Packard
Rob Packard
Rob Packard
Client
TBD
Rob Packard
Client
TBD
TBD
Rob Packard
Rob Packard
TBD
Rob Packard
Rob Packard
N/A
rob@13485cert.com
Slide 28 of 35
Team Member Selection
•
•
•
•
•
•
Boilerplate – 1, 3, 6 & non-applicable
9 - Declarations of Conformity (FDA Form 3654)
Biocompatibility & Sterility – 14 & 15
Software & EMC – 16 & 17
Labeling - 13
Performance Testing
– Bench Testing - 18
– Animal Testing - 19
– Clinical Studies – 20 + Sections 7 & 8
rob@13485cert.com
Slide 29 of 35
Planning Performance Testing
• Look for a special controls guidance
document 1st.
• Look for any device-specific standards
(e.g., ASTM F483)
• Review each of the possible 510(k)
Summaries carefully
• Order 510(k) submissions through FOI
rob@13485cert.com
Slide 30 of 35
Bench Testing
• ASTM testing methods
• Simulated use experiments
• Validation tools (known input data for
software/hardware devices)
• Finite Element Analysis (FEA)
• Cadaveric studies
rob@13485cert.com
Slide 31 of 35
Animal Studies
• The agency allows rationales for reduction of
sample number in order to spare the lives of
animals.
• Try to find another submission or 510(k)
summary that specifies the number of animals
• Test more than once per animal or your device
and the predicate in each animal (i.e., animal is
it’s own control)
• Small animal vs. large animal and duration…
rob@13485cert.com
Slide 32 of 35
Human Studies
• 10-15% of 510(k) submissions require clinical study
data
• Steps:
–
–
–
–
–
Study Synopsis
Investigator Package
Protocol Approval
Conduct Study
Summary Report
• Non-significant risk studies do not require IDE
• IRB approval is always required
• Paper data collection vs. electronic data collection
rob@13485cert.com
Slide 33 of 35
FDA Pre-Sub Meetings
• Guidance released February 18, 2014
• Consultants and RA Experts have used
these for years, but weren’t called
“pre-sub” meetings
• Do your homework 1st
• In-person vs. Tcon
• Timing = Prior to Performance Testing
• Identify Proposed Predicate Device(s)
http://bit.ly/FDA-Pre-Sub
rob@13485cert.com
Slide 34 of 35
Additional Resources
• 17 Blogs about 510(k) Submissions
– http://medicaldeviceacademy.com/category/510k/
• 5 On-Demand Webinars
– http://medicaldeviceacademy.com/510k-submissionpredicate-device/
– http://medicaldeviceacademy.com/live-webinar-on-510ksubmissions-fda-pre-sub-meetings/
– http://medicaldeviceacademy.com/live-webinar-on-510ksubmissions-substantial-equivalence/
– http://medicaldeviceacademy.com/510k-submission-section4-indications-for-use-webinar/
– http://medicaldeviceacademy.com/510k-projectmanagement-webinar/
rob@13485cert.com
Slide 35 of 35
Q&A
rob13485
rob@13485cert.com
+1.802.281.4381
Rob Packard
rob@13485cert.com

How to prepare a 510(k) Submission for the FDA June 4, 2015

Transcription

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