Sec. 3. FDA increased demand reporting with respect to devices
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/bill/116/s/3781/is/section-3·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 506J of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ) is amended— in subsections (c), (e), and (f), by inserting or
(j)after subsection
(a)each place such term appears; and by adding at the end the following: The manufacturer of a device described in subsection
(a)shall notify the Secretary, in accordance with paragraph (2), of any— increase in demand for the device that the manufacturer likely will be unable to meet; or export restrictions or other limitations imposed, on or after the date of enactment of the PART Act , on manufacturing or export of the device by the country in which such device or any component of the device is manufactured. A notice required under paragraph
(1)shall be submitted to the Secretary as soon as practicable but not later than 5 calendar days after the manufacturer becomes aware of the issue requiring notification under such paragraph. A manufacturer of a device who submits a notification to the Secretary under paragraph
(1)shall notify the Secretary after the issue giving rise to such notification has been resolved or when the manufacturer is able to meet demand. .
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Sec. 3
FDA increased demand reporting with respect to devices
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