Guidance For Industry And Food And Drug Administration Staff - U.s. Department Of Health And Human Services - 2012 Page 11
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13Contains Nonbinding Recommendations
Labeling
You should provide any proposed labeling, including proposed promotional material for the
device or any labeling or promotional material of a similar, legally marketed device. If no
proposed labeling is available for the described device or for a similar legally marketed
device, this should be noted in the cover letter.
Additions to a 513(g) Request for Information
Once FDA has received your 513(g) Request for Information and user fee, you may not
modify that 513(g) request by subsequently adding a new question, use, or technology. We
would consider the addition of a new question, use, or technology to a pending Request for
Information to be a new 513(g) request subject to an additional user fee, to which we intend
to respond separately.
VI. Reviewing a 513(g) Request for Information in
CDRH
Upon receipt of the 513(g) Request for Information and the necessary user fee, the Document
Control Center (DCC) will assign a submission number to the 513(g) Request for
Information and forward the request to a review branch in ODE or OIVD for consideration.
The DCC will send an "acknowledgement of receipt" letter to the submitter of the 513(g)
Request for Information. The 513(g) Request for Information will generally be accepted for
review by a branch in ODE or OIVD. Staff from ODE or OIVD and other Offices within
CDRH with appropriate scientific and regulatory expertise will review the information
provided, meet as necessary, and draft a response for signature by the Director, ODE or
Director, OIVD. The response should be responsive to the regulatory question(s) asked in
the 513(g) Request for Information.
VII. Reviewing a 513(g) Request for Information in CBER
Upon receipt of the 513(g) Request for Information and the necessary user fee, the Document
Control Center (DCC) will forward the submission to the CBER 513(g) Coordinator who
will assign a submission number to the 513(g) Request for Information. The CBER 513(g)
Coordinator will then review the 513(g) Request for Information for completeness, confirm
the request is for information respecting the class in which a device has been classified
and/or the requirements applicable to a device under the FD&C Act, and send an
"acknowledgement of receipt" letter to the submitter of the 513(g) Request for Information.
The 513(g) Request for Information will generally be assigned to one of the product review
offices for consideration. Staff from the assigned product review office and other personnel
within CBER with appropriate scientific and regulatory expertise will review the information
provided, meet as necessary, and draft a response for signature by the director of the assigned
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