1. Linda M. Chatwin, Esq. RAC Business Manager, UL LLC
FDA’s 513(g) What is it?
Linda M. Chatwin, Esq. RAC
Business Manager, UL LLC

3. Areas of regulatory expertise:
Developing international regulatory strategy
US FDA 510(k) and other regulatory submissions
Remediation efforts from audit findings
Quality system construction and improvement
Training to QSR, Risk management, RoHS and safety standards
Risk management file construction and maintenance
Gap assessments to various certification standards
21 CFR Part 11 implementation
Performing FDA Mock Audit and other outside auditing
Managing FDA inspections
Developing, implementing and mitigating design control processes

4. Agenda
Guidance
User Fees
Specifics
Who we are
Q&A

5. Guidance

7. Request for information about the class of a device
What is a 513(g)
Request for information about the class of a device
Request for the requirements that apply
Caveat: Guidance does not establish legally enforceable responsibilities
Describe the Agency's current thinking
Recommendations, unless specific regulatory or statutory requirements are cited

8. User Fees
Guidance for Industry and Food and Drug Administration Staff - User Fees for 513(g) Requests for Information
Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA), also termed the Medical Device User Fee Amendments of 2007, P.L , extends FDA’s authority to collect medical device user fees by establishing a fee for “a request for classification information.” 

9. Q&A Regarding 513(g) User Fees
 Are all 513(g) requests subject to a user fee?
Yes
Will FDA refund my user fee payment if you determine that my submission is not a 513(g) Request for Information?
 Will FDA refund my user fee payment if my product does not appear to be a medical device? No
Will FDA refund my user fee payment if my device appears to be exempt from 510(k) premarket notification?

10. Continued
After I submit a 513(g) Request for Information, can I subsequently add a new question, use, or technology without submitting a new user fee? No
Will FDA refund my user fee payment if I withdraw my 513(g) request?
Current 2016 User fees for 513(g) requests
Regular: $3,529; Small Business: $1,765

11. Specifics

12. Forward Obtain the agency's views about classification
Applicable requirements
Within sixty days…, the Secretary shall provide a written statement of the classification (if any) and the requirements applicable to the device.”

13. What if it Isn’t?
Governs requests for information about the classification or requirements
Submissions that do not request such information are outside the scope
If, based solely on the information provided with the request, the product doesn’t appear to be a "device", FDA will inform the requester

14. What does the Request Provide?
The agency's assessment, based on the information submitted in the request, as to the generic type of device (e.g., classification regulation) that the requester's device appears to be within (if any);
The class of devices within that generic type (and if there is more than one class within that generic type, the particular class within which the requestor's device appears to fall)
Whether a PMA, 510(k), or neither is required in order to market devices of the particular class within that generic type

15. Continued
Other requirements applicable to devices of the particular class within that generic type
Whether a guidance document has been issued regarding the exercise of enforcement discretion over the particular class of devices within that generic type
Whether additional FDA requirements may apply, such as those applicable to radiation-emitting products.

16. Equivalency? Safety? Effectiveness?
FDA does not review data related to substantial equivalence
FDA does not review safety and effectiveness
FDA's responses are not device classification decisions
Do not constitute FDA clearance or approval for marketing.

17. Studies?
FDA’s response will not address the specific types of nonclinical, animal, or clinical studies
Consider a Pre-Sub to receive more specific information about your specific testing recommendation

18. What’s Included in the Request?
a cover letter
a description of the device
a description of what the device is to be used for
any proposed labeling or promotional material for the device
labeling or promotional material of a similar, legally marketed device

19. What if it isn’t a Device?
May be another type of product regulated by FDA
Contact information for another department
Appears not to be a product for which FDA has jurisdiction
Combination product where it is not clear which Center has primary jurisdiction.
Contact the Office of Combination Products.

20. FDA is unable to provide information:
Incomplete Request
FDA is unable to provide information:
If your 513(g) Request for Information is incomplete
Or insufficient information is submitted
FDA intends to contact the submitter and request additional information
May consider request withdraw if no response within 30 days
Issue notice of withdrawal

21. Issues FDA’s assessment is not binding and there are no appeal rights
Can argue against FDA’s response in future premarket submission
However, FDA may maintain position consistent with response
FDA will not provide information on substantial equivalence or predicates

22. UL NOW OFFERS – Full Support During Product Life Cycle

23. Summary 513(g) a tool to help with classification concerns
Must be thorough; ask specific questions
Will not bind FDA
Will not provide studies information
Will not provide SE information
May need to file Pre-Sub

24. Questions? Linda M. Chatwin, Esq. RAC Business Manager, UL LLC
Phone: