,,ii #aadth ,,congress #ast ,session ,s4 #afbb ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #ah1 #bjae ,mr4 ,burr 7for himself and ,mr4 ,franken7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to devices4 #a4 ,short title ,this ,act may be cited as the ,,fda ,device ,accountability ,act of #bjae4 #b4 ,ensuring least burdensome means of evaluating devices 7a7 ,training and oversight of least burdensome requirements ,section #eac of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7 is amended by adding at the end the following3 7j7 ,training and oversight of least burdensome requirements 7#a7 ,training and assessment ,the ,secretary shall-- 7,a7 ensure that each employee of the ,food and ,drug ,administration who is involved in the review of premarket submissions1 including supervisors1 receives training regarding the meaning and implementation of the least burdensome requirements under subsections 7a77#c77;,d7 and 7i77#a77;,d7 and section #eae7;c77#e72 and 7,b7 periodically assess the implementation of the least burdensome requirements1 including the employee training under subparagraph 7,a7 to ensure that the least burdensome requirements are fully and consistently applied4 7#b7 ,ombudsman audit ,not later than #ahj calendar days after the date of enactment of the ,,fda ,device ,accountability ,act of #bjae1 the ombudsman for any organizational unit of the ,food and ,drug ,administration responsible for the premarket review of devices shall-- 7,a7 conduct an audit of the training described in paragraph 7#a77;,a72 7,b7 include in such audit interviews of persons who are representatives of the device industry regarding their experience in the device premarket review process1 including with respect to the application of least burdensome concepts to premarket review and the application of postmarket requirements to facilitate premarket decisionmaking2 7,c7 include in such audit an assessment of the measurement tools the ,secretary uses to assess the implementation of the least burdensome requirements1 including the effectiveness of such tools and the effectiveness of the implementation of the least burdensome requirements2 and 7,d7 within #cj calendar days of completion of the audit1 make such audit available-- 7i7 to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives2 and 7ii7 on the ,internet website of the ,food and ,drug ,administration4 4 7b7 ,premarket applications ,section #eae7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7c77 is amended by adding at the end the following3 7#e7 7,a7 ,in requesting additional information with respect to an application under this section1 the ,secretary shall consider the least burdensome appropriate means necessary to demonstrate a reasonable assurance of device safety and effectiveness4 7,b7 ,for purposes of subparagraph 7,a7 the term necessary means the minimum required information that would support a determination by the ,secretary that an application provides a reasonable assurance of the safety and effectiveness of the device4 7,c7 ,nothing in this paragraph alters the standards for premarket approval of a device4 7,d7 ,for purposes of this paragraph1 the ,secretary shall consider whether the least burdensome means of demonstrating a reasonable assurance of device safety and effectiveness would be achieved through reliance on postmarket information4 4 7c7 ,rationale for significant decisions regarding devices ,section #eag;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;g-#a7;a77 is amended by adding at the end the following3 7#c7 ,application of least burdensome requirements ,the substantive summary required under this subsection shall include an explanation of how the least burdensome requirements were considered and applied consistent with section #eac7;i77#a77;,d7 and section #eac7;a77#c77;,d7 and section #eae7;c77#e71 as applicable4 4 #c4 ,permitting non-local institutional review boards 7a7 ,in general ,section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;j77 is amended-- 7#a7 in subsection 7g77#c7-- 7,a7 by striking local each place it appears2 and 7,b7 in subparagraph 7,a77i71 by striking which has been2 and 7#b7 in subsection 7m77#d7-- 7,a7 by striking local each place it appears2 and 7,b7 by amending subparagraph 7,a7 to read as follows3 7,a7 in facilities in which clinical testing of devices is supervised by an institutional review committee established in accordance with the regulations of the ,secretary2 and 4 7b7 ,regulations ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall revise or issue such regulations or guidance as may be necessary to carry out the amendments made by subsection 7a74 #d4 ,clarifying ,,clia waiver study design guidance for in vitro diagnostics 7a7 ,draft revised guidance ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall publish a draft guidance that-- 7#a7 revises section ,v4 ,demonstrating ,insignificant ,risk of an ,erroneous ,result - ,accuracy of the guidance entitled ,recommendations for ,clinical ,laboratory ,improvement ,amendments of #aihh 7,,clia7 ,waiver ,applications for ,manufacturers of ,in ,vitro ,diagnostic ,devices and dated ,january #cj1 #bjjh2 and 7#b7 includes guidance on the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy4 7b7 ,final revised guidance ,the ,secretary of ,health and ,human ,services shall finalize the draft guidance published under subsection 7a7 not later than #a year after the comment period for such draft guidance closes4