1. “513(g)s” Requests for Information Lawrence “Jake” Romanell, RM (AAM) Office of Device Evaluation Center for Devices and Radiological Health

2. Section 513(g) of the Act “Within 60 days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under this Act, the Secretary shall provide such person a written statement of the classification (if any) of such device and the requirements of this Act applicable to the device.”

5. 513(g) “Typical” Inquiries To date, most inquiries are submitted to: –Determine whether a product is subject to FDA regulations. –Determine whether a device is exempt for the 510(k) requirements of the Act. –Determine whether a 510(k) is needed for a modification to one's device. –Determine the least burdensome regulatory pathway for a device, which introduces a new technology or a new intended use.

6. 513(g) Yearly Submissions Calendar YearSubmissions 1990 4 1995 12 2000 69 2002117 2003 180 2004 290 2005311 2006314

7. WHO’S GETTING THE REQUESTS 2003200420052006 REDB 32 43 48 45 GHDB 21 35 40 39 DEDB 8 19 21 33 GSDB 16 25 35 27 RADB 8 24 29 19 OIVD 21 29 28 50 CBER 6

9. FDA responses to requests for information about the regulatory requirements applicable to a particular device DO NOT constitute FDA clearance or approval for distribution of that particular device in the United States.

10. OPINIONS* offered as responses to 513(g) Requests on Software Classified device requiring a 510(k) submission - 54 Classified device exempt from 510(k) requirements - 20 Unclassified device requiring a 510(k) submission - 17 Not a classified device under enforcement discretion - 9 Not a device - 7 General purpose article - 2 Drug regulated by CDER - 2 Biologic regulated by CBER - 2 Classified device requiring a PMA submission - 1 Not a finished device - 1 *-May not be the sole opinion given in response to a request.

11. The FUTURE.... PROPOSED MDUFMA II Fees*: –510(k) Std. Fee$3,404.00 –513(g)Std. Fee$2,498.00 –510(k)Small Business Fee$1,702.00 –513(g) Small Business Fee$1,249.00 *-“The Gray Sheet,” April 23, 2007, Vol. 33, No. 017

12. Contents of a 513(g) Request: User Fee Sheet. A Cover Letter. A complete Device Description. A concise Indication(s) for Use Statement. Either proposed labeling or labeling of a marketed similar product/device.

13. Mailing Address: 513(G) Coordinator Office of Device Evaluation Center for Devices and Radiological Health c/o Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, MD 20850 ORIGINAL AND ONE COPY PLEASE

14. 513(g) Contact Person Lawrence J. (Jake) Romanell Program Operations Staff Office of Device Evaluation Center for Devices and Radiological Health 240-276-4040 lawrence.romanell@fda.hhs.gov

15. Combination Product As defined in 21 CFR §3.2(e), the term combination product includes: (1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; (2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; (3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or (4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

16. Request for Designation (RFD) When the jurisdiction of a combination or non- combination product is unclear or in dispute, a formal request for designation should be submitted to the Office of Combination Products. The formal jurisdiction process for both combination and non-combination/single entity products is accomplished through the Request for Designation (RFD) process, described in 21 CFR Part 3 http://www.fda.gov/oc/ombudsman/part3&5.htm. http://www.fda.gov/oc/ombudsman/part3&5.htm

17. Request for Designation FDA has issued a guidance document "How to Write a Request for Designation" to provide guidance to sponsors on the kind of information FDA needs in an RFD in order to make its jurisdictional determination. The guidance is available at http://www.fda.gov/oc/combination/Guidan ce-How to Write an RFD.pdf. http://www.fda.gov/oc/combination/Guidan ce-How to Write an RFD.pdf

18. Center Jurisdiction Officers CBER: Sheryl Lard-Whiteford, Ph.D., 301-827-0379 CDRH: Stephen Rhodes, CAPT, USPHS, 240-276-4036 CDER: Virginia Behr, 301-443-5581

19. Request for Designation The Office of Combination Products (OCP) will make its jurisdictional determination within 60 days of filing the RFD, as required by 21 CFR 3.8 No User Fees associated with RFD submissions. OCP is averaging just under 100 submissions per year.

20. Office of Combination Products (OCP) OCP Website is http://www.fda.gov/oc/combination/ E-mail OCP at combination@fda.gov. Telephone OCP at (301) 427-1934. Fax OCP at (301) 427-1935. OCP mailing address is 15800 Crabbs Branch Way, Suite 200 (HFG-3), Rockville, MD 20855.