To amend the Federal Food, Drug, and Cosmetic Act with respect to the recognition of standards.

To amend the Federal Food, Drug, and Cosmetic Act with respect to the recognition of standards. 1. Recognition of standards Section 514(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360d(c) (1) in paragraph (1), by inserting after subparagraph (B) the following new subparagraphs: (C) (i) Any person may submit a request for recognition under subparagraph (A) of all or part of an appropriate standard established by a nationally or internationally recognized standard organization. (ii) Not later than 60 days after the Secretary receives such a request, the Secretary shall— (I) make a determination to recognize all, part, or none of the standard that is the subject of the request; and (II) issue to the person who submitted such request a response in writing that states the Secretary’s rationale for that determination, including the scientific, technical, regulatory, or other basis for such determination; (iii) The Secretary make a response issued under clause (ii)(II) publicly available, in such manner as the Secretary determines appropriate. (iv) The Secretary shall take such actions as may be necessary to implement all or part of a standard recognized under subclause (I), in accordance with subparagraph (A). (D) The Secretary shall make publicly available, in such manner as the Secretary determines appropriate, the rationale for recognition under subparagraph (A) of part of a standard, including the scientific, technical, regulatory, or other basis for such recognition. ; and (2) by adding at the end the following new paragraphs: (4) Training on use of standards The Secretary shall provide to all employees of the Food and Drug Administration who review premarket submissions for devices periodic training on the concept and use of recognized standards for purposes of meeting a premarket submission requirement or other applicable requirement under this Act, including standards relevant to an employee’s area of device review. (5) Guidance (A) Draft guidance The Secretary shall publish guidance identifying the principles for recognizing standards under this section. In publishing such guidance, the Secretary shall consider the experience with, and reliance on, a standard by other Federal regulatory authorities and the device industry, and whether recognition of a standard will promote harmonization among regulatory authorities in the regulation of devices. (B) Timing The Secretary shall publish— (i) draft guidance under subparagraph (A) not later than 12 months after the date of the enactment of the 21st Century Cures Act; and (ii) final guidance not later than 12 months of the close of the public comment period for the draft guidance under clause (i). .

Summary: This bill amends the Federal Food, Drug, and Cosmetic Act to allow a person to request that the Food and Drug Administration (FDA) recognize all or part of a performance standard established by a nationally or internationally recognized standard organization as a standard to which a medical device may conform in order to meet an FDA requirement. When a request to recognize a standard is received, the FDA must determine whether to recognize all, part, or none of the standard and publish the rationale for that determination. (Currently, the FDA recognizes certain performance standards, but it is not required to respond to requests or publish rationales for recognizing standards.) The FDA must: (1) publish the rationale for recognizing only part of a standard, (2) periodically train employees who review premarket submissions for medical devices on the concept and use of recognized standards for purposes of meeting requirements, and (3) publish its principles for recognizing standards.