,i #aagth ,,congress #b;d ,session ,h4 ,r4 #gbec ,,in ,,the ,,house ,,of ,,representatives ,march #bh1 #bjbb,mr4 ,peters 7for himself1 ,mr4 ,joyce of ,pennsylvania1 and ,ms4 ,schrier7 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 provide for clarification of requirements for the remanufacturing of medical devices1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,clarifying ,remanufacturing to ,protect ,patient ,safety ,act of #bjbb4 #b4 ,clarification of remanufacturing in definition ,section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 is amended-- 7#a7 by subsection 7a71 by amending paragraph 7#a7 to read as follows3 7#a7 ,the term manufacture1 preparation1 propagation1 compounding1 or processing shall include the following3 7,a7 ,repackaging or otherwise changing the container1 wrapper1 or labeling of any drug package or device package in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user4 7,b7 ,remanufacturing of any finished device by engaging in any act that could significantly change the performance or safety specifications1 or intended use1 of the finished device1 including by significantly changing-- 7i7 a sterilization method2 7ii7 a reprocessing instruction2 7iii7 a control mechanism1 operating principle1 or energy input or output2 7iv7 the anatomical location of use2 or 7v7 the design4 2 and 7#b7 in subsection 7j71 by adding at the end the following3 7#f7 ,the ,secretary shall require that lists of devices reported pursuant to paragraph 7#b7 specifically identify in any such list those devices that have been or are being remanufactured as described in subsection 7a77#a77;,b74 4 #c4 ,inspection of device remanufacturing establishments ,section #eaj7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;h77 is amended-- 7#a7 in paragraph 7#d7-- 7,a7 by redesignating subparagraph 7,h7 as subparagraph 7,g72 and 7,b7 by inserting after subparagraph 7,f7 the following3 7,g7 ,whether the establishment is registered as a remanufacturer or otherwise believed to be engaged in remanufacturing4 2 and 7#b7 in paragraph 7#f77;,a7-- 7,a7 in clause 7i71 by striking and at the end2 7,b7 in clause 7ii71 by inserting and after the semicolon2 and 7,c7 by adding at the end the following3 7iii7 the number of establishments registered as remanufacturers that the ,secretary inspected in the previous calendar year2 4 #d4 ,device remanufacturing public education 7a7 ,in general ,the ,secretary of ,health and ,human ,services shall hold at least one public forum within #ab months after the date of enactment of this ,act1 and shall take other ongoing steps as necessary1 to increase public awareness of the requirements applicable to device remanufacturing1 including-- 7#a7 holding webinars2 and 7#b7 engaging in other outreach to regulated industry1 professional societies1 advocacy groups1 ,state and local governmental entities1 and other stakeholders4 7b7 ,report 7#a7 ,in general ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall-- 7,a7 prepare and post on the website of the ,food and ,drug ,administration a report with regard to the remanufacturing of devices2 and 7,b7 brief the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate regarding the findings of such report4 7#b7 ,contents ,the report under paragraph 7#a7 shall include the following3 7,a7 ,a description of the activities carried out1 and additional activities intended to be carried out1 under subsection 7a74 7,b7 ,the number of remanufacturing establishment registrations and remanufactured device listings under section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj71 and any trends in such registrations and listings4 7,c7 ,an assessment of whether the ,food and ,drug ,administration should issue guidance for remanufacturers on compliance with the establishment registration and device listing requirements of such section #eaj4 7,d7 ,a summary of inspections carried out1 warning letters and other advisory actions1 and enforcement actions relating to remanufacturing establishments since the date of enactment of this ,act4 7,e7 ,the status of actions undertaken pursuant to the report issued by the ,secretary pursuant to section #gaj of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb74 7#c7 ,annual updates ,on an annual basis1 the ,secretary of ,health and ,human ,services shall-- 7,a7 update the report required by this subsection with regard to the information described in subparagraphs 7,b7 and 7,d7 of paragraph 7#b72 and 7,b7 post each such update on the website of the ,food and ,drug ,administration4 7c7 ,definition ,in this section and section #e1 the term device has the meaning given to such term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 #e4 ,enhanced communications regarding remanufacturing ,the ,secretary shall implement a process1 to be posted on the website of the ,food and ,drug ,administration1 to receive through the ,food and ,drug ,administration submissions from ,state regulatory bodies and other ,state authorities-- 7#a7 expressing concerns that an entity that is remanufacturing devices-- 7,a7 is not registered under section #eaj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj72 or 7,b7 may otherwise be acting contrary to the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq472 and 7#b7 describing any actions taken by ,state authorities against such entity4