Guidance For Industry And Food And Drug Administration Staff - U.s. Department Of Health And Human Services - 2012 Page 8
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13Contains Nonbinding Recommendations
submissions under different sections of the FD&C Act. The most common method of
seeking a classification decision is to submit a premarket notification in accordance with
section 510(k) of the FD&C Act (see 21 CFR part 807, subpart E - Premarket Notification
Procedures).
FDA’s response to a 513(g) Request for Information will not address the specific types of
nonclinical, animal, or clinical testing appropriate to support clearance or approval of a
marketing application (when required). You may send a pre-submission to the Document
Control Center for review by the appropriate review branch to receive more specific
information about your specific testing recommendations (for CDRH, see
IDE Approval
Process; for CBER, use contact information supplied on the 513(g) Request for Information
response letter).
A 513(g) response does not constitute final Agency action, but provides responsive
information based on the information provided by the requestor.
C.
Formal Jurisdictional Determinations within FDA
If it is unclear to you which Center has jurisdiction over your product, including any
combination product for which the lead Center has not yet been determined, it may be
appropriate to contact the Office of Combination Products (OCP) to discuss your product's
jurisdiction and whether to submit a formal Request for Designation (RFD) under section
563 of the FD&C Act (21 U.S.C. 360bbb-2) rather than submitting a 513(g) Request for
Information. The RFD process is used to obtain a formal agency determination concerning
the classification of a product as a drug, device, biological product, or combination product
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subject to section 503(g) of the FD&C Act (21 U.S.C. 353(g)),
and/or respecting which
agency component(s) will regulate the product.
IV. Submitting a 513(g) Request for Information
A 513(g) Request for Information must be submitted in writing and should be identified as a
513(g) Request for Information.
For submissions to CDRH, two copies of the request should be sent to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
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Combination product is defined at 21 CFR 3.2(e).
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