DEVICE Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 887 To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness. IN THE HOUSE OF REPRESENTATIVES FEBRUARY 5, 2021 Mr. LIEU (for himself, Ms. CHU, and Ms. NORTON) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure de- vice cleanliness. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Disclosure; and En- 4 couragement of Verification, Innovation, Cleaning, and 5 Efficiency Act of 2021’’ or the ‘‘DEVICE Act of 2021’’. 6 VerDate Sep 11 2014 23:49 Feb 25, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H887.IH H887 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 887 IH SEC. 2. REPORTING REQUIREMENT FOR DESIGN AND RE- 1 PROCESSING INSTRUCTION CHANGES. 2 (a) ADULTERATION.—Section 501 of the Federal 3 Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amend- 4 ed by inserting after paragraph (j) the following: 5 ‘‘(k) If it is a device with respect to which the manu- 6 facturer is in violation of the reporting requirement in sec- 7 tion 510(r) (relating to design and reprocessing 8 changes).’’. 9 (b) REQUIREMENT.—Section 510 of the Federal 10 Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amend- 11 ed by adding at the end the following: 12 ‘‘(r) REPORTING REQUIREMENT FOR DEVICE DE- 13 SIGN CHANGES.—Before making a change to the design 14 of a device, or the reprocessing instructions of a device, 15 that is marketed in interstate commerce, the manufacturer 16 of the device shall give written notice of the change to 17 the Food and Drug Administration.’’. 18 SEC. 3. REPORTING REQUIREMENT FOR CERTAIN COMMU- 19 NICATIONS TO FOREIGN HEALTH CARE PRO- 20 VIDERS. 21 (a) ADULTERATION.—Section 501 of the Federal 22 Food, Drug, and Cosmetic Act (21 U.S.C. 351), as 23 amended by section 2 of this Act, is further amended by 24 inserting after paragraph (k) the following: 25 VerDate Sep 11 2014 23:49 Feb 25, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H887.IH H887 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 887 IH ‘‘(l) If it is a device with respect to which the manu- 1 facturer is in violation of the reporting requirement in sec- 2 tion 510(s) (relating to communications to foreign health 3 care providers).’’. 4 (b) REQUIREMENT.—Section 510 of the Federal 5 Food, Drug, and Cosmetic Act (21 U.S.C. 360), as 6 amended by section 2 of this Act, is further amended by 7 adding at the end the following: 8 ‘‘(s) REPORTING REQUIREMENT FOR CERTAIN COM- 9 MUNICATIONS TO FOREIGN HEALTH CARE PROVIDERS.— 10 ‘‘(1) REQUIREMENT.—The manufacturer of a 11 device that is marketed in interstate commerce shall 12 give written notice to the Food and Drug Adminis- 13 tration of any communication described in para- 14 graph (2) not more than 5 calendar days after mak- 15 ing such communication. 16 ‘‘(2) COMMUNICATION DESCRIBED.—A commu- 17 nication is described in this paragraph if the com- 18 munication— 19 ‘‘(A) is made by the manufacturer of the 20 device or an affiliate of the manufacturer; 21 ‘‘(B) relates to a change to the design of 22 the device, a change to the recommended re- 23 processing protocols, if any, for the device, or a 24 safety concern about the device; and 25 VerDate Sep 11 2014 23:49 Feb 25, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H887.IH H887 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 887 IH ‘‘(C) is widely disseminated (including on a 1 voluntary basis) to health care providers in a 2 foreign country. 3 ‘‘(3) AFFILIATE.—In this subsection, the term 4 ‘affiliate’ means a business entity that has a rela- 5 tionship with a second business entity if, directly or 6 indirectly— 7 ‘‘(A) one business entity controls, or has 8 the power to control, the other business entity; 9 or 10 ‘‘(B) a third party controls, or has the 11 power to control, both of the business entities.’’. 12 SEC. 4. RAPID ASSESSMENT TESTS INTENDED TO ENSURE 13 PROPER REPROCESSING. 14 (a) INCLUSION IN DEVICE DEFINITION.—Section 15 201 of the Federal Food, Drug, and Cosmetic Act (21 16 U.S.C. 321) is amended— 17 (1) in paragraph (h)— 18 (A) in subparagraph (2), by striking ‘‘or’’ 19 at the end; 20 (B) in subparagraph (3), by striking ‘‘and’’ 21 at the end and inserting ‘‘or’’; and 22 (C) by inserting after subparagraph (3) 23 the following: 24 VerDate Sep 11 2014 23:49 Feb 25, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H887.IH H887 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 887 IH ‘‘(4) a rapid assessment test intended to ensure 1 the proper reprocessing of a reusable device (as de- 2 fined in paragraph (ss)), and’’; and 3 (2) by adding at the end the following: 4 ‘‘(ss) The term ‘reusable device’ means a device 5 that— 6 ‘‘(1) is intended to be used more than one time; 7 and 8 ‘‘(2) must be sanitized (whether through clean- 9 ing, disinfection, or sterilization) to ensure that the 10 device is safe and effective for such intended use.’’. 11 (b) INSTRUCTIONS FOR USE AND VALIDATION 12 DATA.—Section 510 of the Federal Food, Drug, and Cos- 13 metic Act (21 U.S.C. 360), as amended by sections 2 and 14 3 of this Act, is further amended by adding at the end 15 the following: 16 ‘‘(t) INSTRUCTIONS FOR USE AND VALIDATION 17 DATA.— 18 ‘‘(1) INITIAL LIST.—Not later than 1 year after 19 the date of enactment of this subsection, the Sec- 20 retary shall by regulation develop and publish a list 21 of types of rapid assessment tests described in sec- 22 tion 201(h)(4) for which reports under subsection 23 (k) must include— 24 VerDate Sep 11 2014 23:49 Feb 25, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H887.IH H887 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 887 IH ‘‘(A) instructions for use that have been 1 validated in a manner specified by the Sec- 2 retary; and 3 ‘‘(B) validation data, of the types specified 4 by the Secretary. 5 ‘‘(2) UPDATES.—The Secretary shall by regula- 6 tion periodically update the list required by para- 7 graph (1). 8 ‘‘(3) ENFORCEMENT.—Beginning on the date 9 of publication of the initial list under paragraph (1), 10 the Secretary shall not accept any notification under 11 subsection (k) for clearance of a type of rapid as- 12 sessment test that is included on such list unless 13 such notification includes instructions for use and 14 validation data in accordance with paragraph (1).’’. 15 Æ VerDate Sep 11 2014 23:49 Feb 25, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H887.IH H887 pamtmann on DSKBC07HB2PROD with BILLS