text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``Disclosure; and Encouragement of 
  Verification, Innovation, Cleaning, and Efficiency Act of 2017'' or the 
  ``DEVICE Act of 2017''.
  
  SEC. 2. REPORTING REQUIREMENT FOR DESIGN AND REPROCESSING INSTRUCTION 
                CHANGES.
  
      (a) Adulteration.--Section 501 of the Federal Food, Drug, and 
  Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph 
  (j) the following:
      ``(k) If it is a device with respect to which the manufacturer is 
  in violation of the reporting requirement in section 510(q) (relating 
  to design and reprocessing changes).''.
      (b) Requirement.--Section 510 of the Federal Food, Drug, and 
  Cosmetic Act (21 U.S.C. 360) is amended by adding at the end the 
  following:
      ``(q) Reporting Requirement for Device Design Changes.--Before 
  making a change to the design of a device, or the reprocessing 
  instructions of a device, that is marketed in interstate commerce, the 
  manufacturer of the device shall give written notice of the change to 
  the Food and Drug Administration.''.
  
  SEC. 3. REPORTING REQUIREMENT FOR CERTAIN COMMUNICATIONS TO FOREIGN 
                HEALTH CARE PROVIDERS.
  
      (a) Adulteration.--Section 501 of the Federal Food, Drug, and 
  Cosmetic Act (21 U.S.C. 351), as amended by section 2 of this Act, is 
  further amended by inserting after paragraph (k) the following:
      ``(l) If it is a device with respect to which the manufacturer is 
  in violation of the reporting requirement in section 510(r) (relating 
  to communications to foreign health care providers).''.
      (b) Requirement.--Section 510 of the Federal Food, Drug, and 
  Cosmetic Act (21 U.S.C. 360), as amended by section 2 of this Act, is 
  further amended by adding at the end the following:
      ``(r) Reporting Requirement for Certain Communications to Foreign 
  Health Care Providers.--
              ``(1) Requirement.--The manufacturer of a device that is 
          marketed in interstate commerce shall give written notice to 
          the Food and Drug Administration of any communication described 
          in paragraph (2) not more than 5 calendar days after making 
          such communication.
              ``(2) Communication described.--A communication is 
          described in this paragraph if the communication--
                      ``(A) is made by the manufacturer of the device or 
                  an affiliate of the manufacturer;
                      ``(B) relates to a change to the design of the 
                  device, a change to the recommended reprocessing 
                  protocols, if any, for the device, or a safety concern 
                  about the device; and
                      ``(C) is widely disseminated (including on a 
                  voluntary basis) to health care providers in a foreign 
                  country.
              ``(3) Affiliate.--In this subsection, the term `affiliate' 
          means a business entity that has a relationship with a second 
          business entity if, directly or indirectly--
                      ``(A) one business entity controls, or has the 
                  power to control, the other business entity; or
                      ``(B) a third party controls, or has the power to 
                  control, both of the business entities.''.
  
  SEC. 4. RAPID ASSESSMENT TESTS INTENDED TO ENSURE PROPER REPROCESSING.
  
      (a) Inclusion in Device Definition.--Section 201 of the Federal 
  Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended--
              (1) in paragraph (h)--
                      (A) in subparagraph (2), by striking ``or'' at the 
                  end;
                      (B) in subparagraph (3), by striking ``and'' at the 
                  end and inserting ``or''; and
                      (C) by inserting after subparagraph (3) the 
                  following:
              ``(4) a rapid assessment test intended to ensure the proper 
          reprocessing of a reusable device (as defined in paragraph 
          (ss)), and''; and
              (2) by adding at the end the following:
      ``(ss) The term `reusable device' means a device that--
              ``(1) is intended to be used more than one time; and
              ``(2) must be sanitized (whether through cleaning, 
          disinfection, or sterilization) to ensure that the device is 
          safe and effective for such intended use.''.
      (b) Instructions for Use and Validation Data.--Section 510 of the 
  Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360), as amended by 
  sections 2 and 3 of this Act, is further amended by adding at the end 
  the following:
      ``(s) Instructions for Use and Validation Data.--
              ``(1) Initial list.--Not later than 1 year after the date 
          of enactment of this subsection, the Secretary shall by 
          regulation develop and publish a list of types of rapid 
          assessment tests described in section 201(h)(4) for which 
          reports under subsection (k) must include--
                      ``(A) instructions for use that have been validated 
                  in a manner specified by the Secretary; and
                      ``(B) validation data, of the types specified by 
                  the Secretary.
              ``(2) Updates.--The Secretary shall by regulation 
          periodically update the list required by paragraph (1).
              ``(3) Enforcement.--Beginning on the date of publication of 
          the initial list under paragraph (1), the Secretary shall not 
          accept any notification under subsection (k) for clearance of a 
          type of rapid assessment test that is included on such list 
          unless such notification includes instructions for use and 
          validation data in accordance with paragraph (1).''.
target: Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of  2017 or the DEVICE Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require medical device manufacturers to notify the Food and Drug Administration (FDA): (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. A device may not be sold if the manufacturer violates these notification requirements. Rapid assessment tests intended to ensure the proper reprocessing of reusable medical devices are defined as medical devices. The FDA must publish a list of the types of rapid assessment tests for which premarket notification must include validated instructions for use and validation data.
feat_title: Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2017