FDA’s 513(g) Guidance: Understanding the User Fees and Requests

1. 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

6. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm209851.pdfhttp://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm209851.pdf

7. 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 • http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm209852.htm • 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. 110-85, extends FDA’s authority to collect medical device user feesby 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? • Yes •  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? • No

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? • No • 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. 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

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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 Email: linda.chatwin@ul.com Phone: 360-817-5556