Sec. 702. IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE ESTABLISHMENTS
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## SEC. 702 IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE ESTABLISHMENTS ###
(a)In general Section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) is amended by adding at the end the following: > > ### “(h) > > > ####
(1)> > In the case of inspections other than for-cause inspections, the Secretary shall review processes and standards applicable to inspections of domestic and foreign device establishments in effect as of the date of the enactment of this subsection, and update such processes and standards through the adoption of uniform processes and standards applicable to such inspections. Such uniform processes and standards shall provide for— > > > ##### “(A) > > exceptions to such processes and standards, as appropriate; > > > ##### “(B) > > announcing the inspection of the establishment within a reasonable time before such inspection occurs, including by providing to the owner, operator, or agent in charge of the establishment a notification regarding the type and nature of the inspection; > > > ##### “(C) > > a reasonable estimate of the timeframe for the inspection, an opportunity for advance communications between the officers or employees carrying out the inspection under subsection (a)(1) and the owner, operator, or agent in charge of the establishment concerning appropriate working hours during the inspection, and, to the extent feasible, advance notice of some records that will be requested; and > > > ##### “(D) > > regular communications during the inspection with the owner, operator, or agent in charge of the establishment regarding inspection status, which may be recorded by either party with advance notice and mutual consent. > > > #### “(2) > > > #####
(A)> > The Secretary shall, with respect to a request described in subparagraph (B), provide nonbinding feedback with respect to such request not later than 45 days after the Secretary receives such request. > > > ##### “(B) > > A request described in this subparagraph is a request for feedback— > > > ###### “(i) > > that is made by the owner, operator, or agent in charge of such establishment in a timely manner; and > > > ###### “(ii) > > with respect to actions proposed to be taken by a device establishment in a response to a report received by such establishment pursuant to subsection
(b)that involve a public health priority, that implicate systemic or major actions, or relate to emerging safety issues (as determined by the Secretary). > > > #### “(3) > > Nothing in this subsection affects the authority of the Secretary to conduct inspections otherwise permitted under this Act in order to ensure compliance with this Act.” > . ###
(b)Guidance **[**[21 U.S.C. 374 note](/us/usc/t21/s374)**]** ####
(1)Draft guidance Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance that— #####
(A)specifies how the Food and Drug Administration will implement the processes and standards described in paragraph
(1)of subsection
(h)of section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added by subsection (a), and the requirements described in paragraph
(2)of such subsection (h); #####
(B)provides for standardized methods for communications described in such paragraphs; #####
(C)establishes, with respect to inspections of both domestic and foreign device establishments (as referred to in section 510(h)(2) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a)), a standard timeframe for such inspections— ######
(i)that occurs over consecutive days; and ######
(ii)to which each investigator conducting such an inspection shall adhere unless the investigator identifies to the establishment involved a reason that more time is needed to conduct such investigation; and #####
(D)identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments. ####
(2)Final guidance Not later than 1 year after providing notice and opportunity for public comment on the draft guidance issued under paragraph (1), the Secretary of Health and Human Services shall issue final guidance to implement subsection
(h)of section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added by subsection (a)**. ###
(c)Adulterated Devices Subsection
(j)of section 501 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended by inserting “or device” after “drug”.
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