Guidance For Industry And Food And Drug Administration Staff - U.s. Department Of Health And Human Services - 2012 Page 13
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13Contains Nonbinding Recommendations
If your 513(g) Request for Information is incomplete and we are unable to provide
information regarding classification and/or applicable requirements because you have not
submitted sufficient information to us, we intend to contact the submitter and request
additional information. If FDA does not receive a response within 30 days of our request, we
may consider a 513(g) to be withdrawn. In this instance, FDA may issue a notice of
withdrawal.
IX. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44
U.S.C.
3501-3520).
The time required to complete this information collection is estimated to average 12 hours
per response, including the time to review instructions, search existing data sources, gather
the data needed, and complete and review the information collection. Send comments
regarding this burden estimate or suggestions for reducing this burden to:
510(k) Staff, Program Operations Staff, Office of Device Evaluation, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg.
66, Silver Spring, MD 20993.
This guidance also refers to currently approved collections of information found in FDA
regulations. The collections of information in 21 CFR 807 subpart E have been approved
under OMB control number 0910-0120; the collections of information in 21 CFR part 814
have been approved under OMB control number 0910-0231; the collections of information in
21 CFR part 801 have been approved under OMB control number 0910-0485; and the
collections of information in 21 CFR 860.123 have been approved under OMB control
number 0910-0138.
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