DEVICE INSPECTIONS.

SEC. 3611. DEVICE INSPECTIONS.(a) In General.—Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by striking “restricted devices” each place it appears and inserting “devices”. (b) Records or Other Information.—(1) Establishments.—Section 704(a)(4)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)(A)) is amended—(A) by striking “an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug” and inserting “an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or a site or facility that is subject to inspection under paragraph (5)(C),”; and (B) by striking “records requested.” and inserting the following: “records or other information requested and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection.”. (2) Guidance.—(A) In general.—The Secretary shall issue or update guidance describing—(i) circumstances in which the Secretary intends to issue requests for records or other information in advance of, or in lieu of, an inspection under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act, as amended by paragraph (1); (ii) processes for responding to such requests electronically or in physical form; and (iii) factors the Secretary intends to consider in evaluating whether such records and other information are provided within a reasonable timeframe, within reasonable limits, and in a reasonable manner, accounting for resource and other limitations that may exist, including for small businesses. (B) Timing.—The Secretary shall—(i) not later than 1 year after the date of enactment of this Act, issue draft guidance under subparagraph (A); and (ii) not later than 1 year after the close of the comment period for such draft guidance, issue final guidance under subparagraph (A).