“513(g)s”Requests for Information

Lawrence “Jake” Romanell, RM (AAM)

Office of Device Evaluation

Center for Devices and Radiological Health

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.”

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.

513(g) Yearly Submissions

Calendar Year Submissions1990 41995 122000 692002 1172003 1802004 2902005 3112006 314

WHO’S GETTING THE REQUESTS

2003 2004 2005 2006REDB 32 43 48 45GHDB 21 35 40 39DEDB 8 19 21 33GSDB 16 25 35 27RADB 8 24 29 19

OIVD 21 29 28 50

CBER 6

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.

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.

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

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.

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

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

Combination ProductAs 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.

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.

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/Guidance-How to Write an RFD.pdf.

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

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.

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.