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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation)

Author: [none given]

2017-08-02

SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by September 1, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All [[Page 35972]] comments should be identified with the OMB control number 0910-NEW and title ``De Novo Classification Process (Evaluation of Automatic Class III Designation).'' Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. De Novo Classification Process (Evaluation of Automatic Class III Designation) OMB Control Number 0910--NEW The draft guidance entitled ``De Novo Classification Process (Evaluation of Automatic Class III Designation)'' provides guidance on the process for the submission and review of a De Novo classification request (hereafter a ``De Novo request'') under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(2)), also known as the De Novo classification process. This process provides a pathway to class I or class II classification for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. The proposed collection of information is necessary to satisfy the previously mentioned statutory requirements for implementing this voluntary submission program. In the Federal Register of August 14, 2014 (79 FR 47651), FDA published a 60-day notice requesting public comment on the proposed collection of information. Seven organizations commented on the draft guidance document. None of the comments were related to the information collection. Upon further review of the information collection, it has come to our attention that the 60-day notice did not include an estimated hour burden for requests for withdrawal or estimated operating and maintenance costs for eCopy,\1\ printing, and shipping of De Novo submissions. To correct this oversight, we have included these estimates here.

FDA, HHS, [Docket No. FDA-2011-D-0689]

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