Guidance For Industry And Food And Drug Administration Staff - U.s. Department Of Health And Human Services - 2012 Page 9

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Contains Nonbinding Recommendations
For submissions to CBER, two copies of the request should be sent to:
CBER 513(g) Coordinator
Food and Drug Administration
Center for Biologics Evaluation and Research
10903 New Hampshire Avenue
WO71-G112
Silver Spring, MD 20993-0002
User Fees
The Act, as amended by the FDA Amendments Act of 2007 (FDAAA) (Public Law 110-85),
requires FDA to collect user fees for 513(g) Requests for Information. See section
738(a)(2)(A)(ix) of the FD&C Act (21 U.S.C. 379j(a)(2)(A)(ix)). FDA may not accept your
513(g) for review until you have paid all fees owed, including all required establishment
registration fees. See section 738(f)(1) of the FD&C Act (21 U.S.C. 379j(f)(1)). When FDA
has received all fees owed, our review of your 513(g) Request for Information will begin as
of that date.
As explained above, if the submission does not request information respecting the class in
which a device has been classified and/or the requirements applicable to a device under the
Act, it is not a Request for Information governed by section 513(g) of the Act. Such requests
do not require a response from FDA. FDA intends to refund any user fee submitted with a
request that is not governed by section 513(g) of the FD&C Act.
For additional information on user fees for 513(g) requests for information see the guidance
document “User Fees and Refunds for 513(g) Requests for Information.”
V. Contents of a 513(g) Request for Information
The 513(g) Request for Information should contain the following:
· a cover letter,
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· a description of the device,
· a description of what the device is to be used for, and
· any proposed labeling or promotional material for the device and, as applicable, any
labeling or promotional material of a similar, legally marketed device, if available.
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A 513(g) Request for Information should seek classification information and/or regulatory requirements for a
single product and may include multiple uses of the product. Requests for classification information and
regulatory requirements for multiple products should be divided up so that a separate Request for Information
and user fee are submitted for each product.
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