Transcript “513(g)s” Requests for Information

“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
1990
1995
2000
2002
2003
2004
2005
2006
Submissions
4
12
69
117
180
290
311
314
WHO’S GETTING THE
REQUESTS
REDB
GHDB
DEDB
GSDB
RADB
2003
32
21
8
16
8
2004
43
35
19
25
24
2005
48
40
21
35
29
2006
45
39
33
27
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
– 513(g) Small Business Fee
$1,702.00
$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
[email protected]
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.
Request for Designation
(RFD)
• When the jurisdiction of a combination or noncombination 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/Guidan
ce-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 [email protected].
• 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.