1. 510k Submission Overview
Myraqa, Inc.
August 22, 2012

2. About Myraqa, Inc. Myraqa is the leading IVD consulting firm
Headquarters in Silicon Valley
Clients include IVD manufacturers, pharma, clinical labs, investors and other industry stakeholders

3. About Myraqa, Inc. Team-Driven Success
We employ leading experts in IVD Regulatory, Quality, Clinical, Biostatistics, Development and Marketing
Team approach best combines diverse expertise
Team members are employees, not contractors
All senior staff have at least 15 years of relevant experience, most have considerably more

4. What is a 510(k)? Premarket Notification
Section 510(k) of Federal Food, Drug, & Cosmetic Act
21 CFR 807 Subpart E
Marketing Clearance Application
Allows FDA to Determine Substantial Equivalence (SE)
Classification process for a device

5. What a 510(k) Is Not A Form Establishment Registration Device Listing
Premarket Approval (PMA)

6. What is a Predicate?
An identification of the legally marketed device to which the submitter claims equivalence. A legally marketed device to which a new device may be compared for a determination regarding substantial equivalence is:
a device that was legally marketed prior to May 28, 1976,
or a device which has been reclassified from class III to class II or I (the predicate),
or a device which has been found to be substantially equivalent through the 510(k) process;

7. Regulatory Classes for Devices
Three Regulatory Classes (level of control based on risk):
Class I – General Controls
Class II – General Controls, Special Controls and Premarket Notification
Class III – General Controls and Premarket Approval
Notes: Most Class II and some Class I are subject to 510k premarket notification

8. General Controls
Class I devices are subject to the least regulatory control and are subject to “General Controls”
General controls include:
Establishment Registration of companies which are required to register under 21 CFR , such as manufacturers, distributers, repackages and relabelers
Medical Device Listing with FDA of devices to be marketed
Manufacturing devices in accordance with current Good Manufacturing Practices (Quality System Regulation in 21 CFR 820)
Labeling devices in accordance with labeling regulations in 21 CFR 801 or 908
Submission of a premarket notification [510(k)] before marketing a device

9. Special Controls
May include special labeling requirements, mandatory performance standards and post-market surveillance

10. 510(k) Submission Required When?
Introducing a device to the U.S. market for the first time
Change in indications for use for a previously cleared device
Making significant modification to a previously cleared device

11. Who Must Submit a 510(k)? Device Manufacturers
Specifications Developers
Repackagers who change device or its labeling
Relabelers who change the labeling- e.g., instructions for use
Anyone who both manufactures & distributes
A company that distributes devices but does not perform any of the other functions above is not required to submit a 510(k)
Who is Not Required to Submit a 510(k)?
Private Label Distributor who ONLY adds company name & wording such as:
“Distributed by ___________” or “Manufactured for _________”
Repackager who does not alter labeling
Distributor or Importer who furthers marketing of the legally marketed device and does not alter labeling or change device

12. Intended Use Statement
FDA generally regulates devices according to the intended use – not the technology used to generate the information
Intended use statement
includes a general description of diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate including a description, where appropriate of the patient population for which the device intended (21 CFR Part 812.2)

13. Systems Approach
FDA takes a ‘systems approach’ to the regulation of devices and IVDs
Reagents, instruments, software – everything that is needed to produce a diagnostic result must be included
Can utilize a partnership approach with parallel submissions
Examples
Affymetrix/Roche
CDC/Applied Biosystems

14. Device Classifications
There are three classifications of devices
Class I: Low Risk
Often 510(k) Exempt
General Controls
Examples: General purpose reagents, Mass spectrometers
Class II: Moderate Risk
Require 510(k) clearance before commercialization
General Controls + Special Controls (e.g., clinical testing)
Class III: High Risk
Require Premarket Approval (PMA)
PMA inspection
Special Controls are typically documented in an FDA Guidance document.

15. Contents of a 510(k) Medical Device User Fee Cover Sheet
CDRH Premarket Review Submission Cover Sheet
Cover Letter
Intended Use / Indications for Use
510(k) Summary
Truthful and Accurate Statement
Financial Certification or Disclosure Statements
Executive Summary
Note the 510K summary is publicly available once your device is cleared so only provide what’s required in this section and avoid anything considered proprietary.
Prior to submitting 510(k) need to submit the User Fee. Fiscal year 2012 $4049 and $2024 for companies that qualify for small business exemption. New fees will be in effect Oct. 1st. Change $4960 and$ 2480.

16. Contents of a 510(k) (Cont)
Device Description
Include all reagents and instruments used
This is where we give FDA the details on how our product works
Proposed Labeling
Will include Package Insert or Operator’s Manual (Instructions for Use)
Kit and component labeling
Stability
Studies conducted and results (Real-Time)
Software
Requirements outlined in Software Guidance document

17. Contents of a 510(k) (Cont)
Performance Testing
Analytical/bench testing – Often multiple studies
Animal testing (if required)
Clinical testing –external clinical sites (typically 3 site minimum)
Approximately 10% of all 510(k)s
Important difference with the predicate device, e.g., new indication for use or new technology
Must be collected under Investigational Device Exemption Regulations (21 CFR Part 812)

18. FDA 510(k) Review
FDA recently published Refuse to Accept Policy for 510(k)s, which also includes administrative checklists for Traditional, Abbreviated and Special 510(k)s.
Administrative Review
Administrative review will be completed within 15 days of receipt of 510(k)
Assessment of completeness of 510(k) not the quality of information
The submitter will be notified in writing if the 510(k) was found administratively complete or incomplete.
If incomplete submitter has 30 days to respond to the RTA letter
either provide the missing information or
request an extension request for up to 180 days from the date of the RTA letter.
If complete FDA staff can begin the substantive
Purpose of revised guidance is to improve efficiency of reviews. In past FDA has accepted inadequate submissions for review and FDA staff invests significant time in constructing extensive letters requesting additional information to conduct a substantive review. Goal of new guidance is to clarify content needed to allow FDA to conduct a substantive review , hopefully improving the quality of 510k submissions and overall review time.
Extensions are granted.

19. FDA 510(k) Review Substantive Review
Review of content and quality of information submitted
FDA may request additional information/performance data to determine substantial equivalence to the predicate
Reviewer requests by telephone, or formal letter (from Doc Center)
Clock stops by letter only
Submit additional information to Document Mail Center
30 days to submit
May request an extension within 30 days of the request for additional information
The request for extension should state the reason and time needed
The 510(k) may be deleted from the 510(k) tracking system if there is no response to the request for additional information within 30 days of FDA’s request letter

20. Substantial Equivalence (SE)
Device is Substantially Equivalent to predicate if:
Has the same intended use, and
Has the same technological characteristics as the predicate device, Or
Has different technological characteristics and the information in the 510(k):
Does not raise new questions of safety and effectiveness, and
Demonstrates new device at least as safe and effective as the predicate

21. Not Substantially Equivalent (NSE)
There is no predicate device
Has a NEW intended use
Has different technological characteristics compared to the predicate device and raises a new questions regarding safety and effectiveness
The NSE determination did not include data review and will require PMA or De Novo

22. Not Substantially Equivalent (NSE) (Cont)
Does not demonstrate device is at least as safe and effective as the predicate
The NSE determination included data review and is eligible for a new 510(k) with new data
Approximately 3% are found NSE
Data is looked at last in the 510(k) regulatory review process
FDA usually asks for additional information at least once prior to determining the device is NSE for lack of data

23. Key Take-Aways
Review relevant FDA guidance documents and search the releasable 510(k) database
510(k) summaries and decision summaries for similar products
Use new RTA Checklist
Confirm regulatory pathway with FDA
Pre-IDE or Pre-Submission Meetings
Lorry will cover pre-Submission meetings in more detail

24. Thank You