,i #aafth ,,congress #ast ,session ,h4 ,r4 #hah ,,in ,,the ,,house ,,of ,,representatives ,january #bh1 #bjai,mr4 ,ted ,lieu of ,california 7for himself1 ,ms4 ,judy ,chu of ,california1 ,mr4 ,cummings1 ,ms4 ,norton1 and ,mr4 ,grijalva7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to enhance medical device communications and ensure device cleanliness4 #a4 ,short title ,this ,act may be cited as the ,disclosure2 and ,encouragement of ,verification1 ,innovation1 ,cleaning1 and ,efficiency ,act of #bjai or the ,,device ,act of #bjai4 #b4 ,reporting requirement for design and reprocessing instruction changes 7a7 ,adulteration ,section #eja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea7 is amended by inserting after paragraph 7j7 the following3 7k7 ,if it is a device with respect to which the manufacturer is in violation of the reporting requirement in section #eaj7r7 7relating to design and reprocessing changes74 4 7b7 ,requirement ,section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 is amended by adding at the end the following3 7r7 ,reporting requirement for device design changes ,before making a change to the design of a device1 or the reprocessing instructions of a device1 that is marketed in interstate commerce1 the manufacturer of the device shall give written notice of the change to the ,food and ,drug ,administration4 4 #c4 ,reporting requirement for certain communications to foreign health care providers 7a7 ,adulteration ,section #eja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea71 as amended by section #b of this ,act1 is further amended by inserting after paragraph 7k7 the following3 7l7 ,if it is a device with respect to which the manufacturer is in violation of the reporting requirement in section #eaj7s7 7relating to communications to foreign health care providers74 4 7b7 ,requirement ,section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj71 as amended by section #b of this ,act1 is further amended by adding at the end the following3 7s7 ,reporting requirement for certain communications to foreign health care providers 7#a7 ,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 7#b7 not more than #e calendar days after making such communication4 7#b7 ,communication described ,a communication is described in this paragraph if the communication-- 7,a7 is made by the manufacturer of the device or an affiliate of the manufacturer2 7,b7 relates to a change to the design of the device1 a change to the recommended reprocessing protocols1 if any1 for the device1 or a safety concern about the device2 and 7,c7 is widely disseminated 7including on a voluntary basis7 to health care providers in a foreign country4 7#c7 ,affiliate ,in this subsection1 the term affiliate means a business entity that has a relationship with a second business entity if1 directly or indirectly-- 7,a7 one business entity controls1 or has the power to control1 the other business entity2 or 7,b7 a third party controls1 or has the power to control1 both of the business entities4 4 #d4 ,rapid assessment tests intended to ensure proper reprocessing 7a7 ,inclusion in device definition ,section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is amended-- 7#a7 in paragraph 7h7-- 7,a7 in subparagraph 7#b71 by striking or at the end2 7,b7 in subparagraph 7#c71 by striking and at the end and inserting or2 and 7,c7 by inserting after subparagraph 7#c7 the following3 7#d7 a rapid assessment test intended to ensure the proper reprocessing of a reusable device 7as defined in paragraph 7ss771 and 2 and 7#b7 by adding at the end the following3 7ss7 ,the term reusable device means a device that-- 7#a7 is intended to be used more than one time2 and 7#b7 must be sanitized 7whether through cleaning1 disinfection1 or sterilization7 to ensure that the device is safe and effective for such intended use4 4 7b7 ,instructions for use and validation data ,section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj71 as amended by sections #b and #c of this ,act1 is further amended by adding at the end the following3 7t7 ,instructions for use and validation data 7#a7 ,initial list ,not later than #a year after the date of enactment of this subsection1 the ,secretary shall by regulation develop and publish a list of types of rapid assessment tests described in section #bja7;h77#d7 for which reports under subsection 7k7 must include-- 7,a7 instructions for use that have been validated in a manner specified by the ,secretary2 and 7,b7 validation data1 of the types specified by the ,secretary4 7#b7 ,updates ,the ,secretary shall by regulation periodically update the list required by paragraph 7#a74 7#c7 ,enforcement ,beginning on the date of publication of the initial list under paragraph 7#a71 the ,secretary shall not accept any notification under subsection 7k7 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 7#a74 4