,,ii #aadth ,,congress #b;d ,session ,s4 #bgcg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #ag1 #bjaf ,ms4 ,klobuchar 7for herself and ,mr4 ,roberts7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to improve medical device innovation4 #a4 ,short title ,this ,act may be cited as the ,improving ,medical ,device ,innovation ,act4 #b4 ,recognition of standards 7a7 ,in general ,section #ead7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7c77 is amended-- 7#a7 in paragraph 7#a71 by inserting after subparagraph 7,b7 the following new subparagraphs3 7,c7 7i7 ,any person may submit a request for recognition under subparagraph 7,a7 of all or part of an appropriate standard established by a nationally or internationally recognized standard organization4 7ii7 ,not later than #fj calendar days after the ,secretary receives such a request1 the ,secretary shall-- 7,i7 make a determination to recognize all1 part1 or none of the standard that is the subject of the request2 and 7,,ii7 issue to the person who submitted such request a response in writing that states the ,secretary's rationale for that determination1 including the scientific1 technical1 regulatory1 or other basis for such determination4 7iii7 ,the ,secretary shall take such actions as may be necessary to implement all or part of a standard recognized under subclause 7,i7 of clause 7ii71 in accordance with subparagraph 7,a74 7,d7 ,the ,secretary shall make publicly available1 in such manner as the ,secretary determines appropriate1 the rationale for recognition of all1 part1 or none of a standard1 including the scientific1 technical1 regulatory1 or other basis for the decision regarding such recognition4 2 and 7#b7 by adding at the end the following3 7#d7 ,training on use of standards ,the ,secretary shall provide to all employees of the ,food and ,drug ,administration who review premarket submissions for devices periodic training on the concept and use of recognized standards for purposes of meeting a premarket submission requirement or other applicable requirement under this ,act1 including standards relevant to an employee's area of device review4 4 7b7 ,guidance ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall review and update1 if necessary1 previously published guidance and standard operating procedures identifying the principles for recognizing standards1 and for withdrawing the recognition of standards1 under section #ead7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7c771 taking into account the experience with and reliance on a standard by foreign regulatory authorities and the device industry1 and whether recognition of a standard will promote harmonization among regulatory authorities in the regulation of devices4 #c4 ,certain class ,i and class ,,ii devices 7a7 ,class i devices ,section #eaj7l7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7l77 is amended-- 7#a7 by striking ,a report under subsection 7k7 and inserting 7#a7 ,a report under subsection 7k72 and 7#b7 by adding at the end the following new paragraph3 7#b7 ,not later than #abj calendar days after the date of enactment of the ,improving ,medical ,device ,innovation ,act and at least once every #e years thereafter1 as the ,secretary determines appropriate1 the ,secretary shall identify1 through publication in the ,federal ,register1 any type of class ,i device that the ,secretary determines no longer requires a report under subsection 7k7 to provide reasonable assurance of safety and effectiveness4 ,upon such publication-- 7,a7 each type of class ,i device so identified shall be exempt from the requirement for a report under subsection 7k72 and 7,b7 the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption4 4 7b7 ,class ,,ii devices ,section #eaj7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7m77 is amended-- 7#a7 by striking paragraph 7#a7 and inserting the following new paragraph3 7#a7 ,the ,secretary shall-- 7,a7 not later than #ij days after the date of enactment of the ,improving ,medical ,device ,innovation ,act and at least once every #e years thereafter1 as the ,secretary determines appropriate-- 7i7 publish in the ,federal ,register a notice that contains a list of each type of class ,,ii device that the ,secretary determines no longer requires a report under subsection 7k7 to provide reasonable assurance of safety and effectiveness2 and 7ii7 provide for a period of not less than #fj calendar days for public comment beginning on the date of the publication of such notice2 and 7,b7 not later than #baj calendar days after the date of enactment of the ,improving ,medical ,device ,innovation ,act1 publish in the ,federal ,register a list representing the ,secretary's final determination with respect to the devices contained in the list published under subparagraph 7,a74 2 and 7#b7 in paragraph 7#b7-- 7,a7 by striking #a day after the date of publication of a list under this subsection1 and inserting #a calendar day after the date of publication of the final list under paragraph 7#a77;,b712 and 7,b7 by striking #cj-;day period and inserting #fj-;calendar-day period2 and 7,c7 by adding at the end the following new paragraph3 7#c7 ,upon the publication of the final list under paragraph 7#a77;,b7-- 7,a7 each type of class ,,ii device so listed shall be exempt from the requirement for a report under subsection 7k72 and 7,b7 the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption4 4 #d4 ,classification panels 7a7 ,classification panels ,paragraph 7#e7 of section #eac7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77 is amended-- 7#a7 by striking 7#e7 and inserting 7#e77;,a72 and 7#b7 by adding at the end the following3 7,b7 ,when a device is specifically the subject of review by a classification panel1 the ,secretary shall-- 7i7 ensure that adequate expertise is represented on the classification panel to assess-- 7,i7 the disease or condition which the device is intended to cure1 treat1 mitigate1 prevent1 or diagnose2 and 7,,ii7 the technology of the device2 and 7ii7 provide an opportunity for the person whose device is specifically the subject of panel review to provide recommendations on the expertise needed among the voting members of the panel4 7,c7 ,for purposes of subparagraph 7,b77i71 the term adequate expertise means that the membership of the classification panel includes-- 7i7 two or more voting members1 with a specialty or other expertise clinically relevant to the device under review2 and 7ii7 at least one voting member who is knowledgeable about the technology of the device4 7,d7 ,the ,secretary shall provide an annual opportunity for patients1 representatives of patients1 and sponsors of medical device submissions to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels4 4 7b7 ,panel review process ,section #eac7;b77#f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77#f77 is amended-- 7#a7 in subparagraph 7,a77iii71 by inserting before the period at the end 1 including by designating a representative who will be provided a time during the panel meeting to address the panel individually 7or accompanied by experts selected by such representative7 for the purpose of correcting misstatements of fact or providing clarifying information1 subject to the discretion of the panel chairperson2 and 7#b7 by striking subparagraph 7,b7 and inserting the following new subparagraph3 7,b7 7i7 ,any meeting of a classification panel with respect to the review of a device shall-- 7,i7 provide adequate time for initial presentations by the person whose device is specifically the subject of such review and by the ,secretary2 and 7,,ii7 provide adequate time for and encourage free and open participation by all interested persons4 7ii7 ,following the initial presentations described in clause 7i71 the panel may-- 7,i7 pose questions to the designated representative described in subparagraph 7,a77iii72 and 7,,ii7 consider the responses to such questions in the panel's review of the device4 4 #e4 ,postmarket pilot to improve medical device reporting 7a7 ,pilot projects 7#a7 ,in general ,in order to improve the value and efficiency of reporting so as to advance the objectives of section #eai7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;i7a771 within one year of the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall establish one or more pilot projects1 in coordination with device manufacturers1 to explore and evaluate the use of alternative methods of compliance with such subsection for manufacturers of devices described in section #eac7;a77#a77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7a77#a77;,c774 7#b7 ,voluntary participation ,participation in such pilot projects shall be voluntary for device manufacturers4 ,the ,secretary may establish the conditions for such voluntary participation and may establish a process for authorizing participation4 7#c7 ,purposes ,the pilot projects established under paragraph 7#a7 shall be designed to-- 7,a7 test methods of reporting for one or more device types1 with priority given to devices for which device manufacturers submit a relatively high volume of reports under the regulations implementing section #eai7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;i7a772 7,b7 evaluate forms of data monitoring and reporting that improve the usability of report data by focusing on events and information that are most relevant to reasonably assuring the safety and effectiveness of the device2 7,c7 identify methods of reporting that will be least burdensome for device manufacturers2 and 7,d7 evaluate methods that are alternative to1 and do not duplicate1 compliance with requirements of part #hjc of title #ba1 ,code of ,federal ,regulations 7or successor regulations74 7#d7 ,notification to congress ,the ,secretary of ,health and ,human ,services shall notify the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives not later than #ah months after the date of enactment of this ,act of the number of manufacturers that have agreed to participate in a pilot project under this subsection with the ,secretary of ,health and ,human ,services4 7#e7 ,rule of construction ,nothing in this subsection shall limit the authority of the ,secretary of ,health and ,human ,services to provide for alternative methods of medical device reporting under part #hjc of title #ba1 ,code of ,federal ,regulations 7or successor regulations71 including such methods described in this subsection4 7#f7 ,compliance with requirements for records or reports on devices 7,a7 ,in general ,a device manufacturer that participates in a pilot project under this subsection shall be required to comply with all applicable provisions of section #eai of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;i71 and implementing regulations1 except as described in subparagraph 7,b74 7,b7 ,conditional exemption ,the ,secretary may determine that1 for a specified time period to be determined by the ,secretary1 a manufacturer participating in a pilot project under this subsection is exempt from certain provisions of section #eai7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;i7a771 and implementing regulations1 if such manufacturer complies with the conditions set forth in a pilot project under this subsection4 7b7 ,,gao review 7#a7 ,review of pilot projects ,the ,comptroller ,general of the ,united ,states shall conduct a review of the pilot projects established under subsection 7a71 and of the reporting system under part #hjc of title #ba1 ,code of ,federal ,regulations 7or successor regulations74 7#b7 ,report ,not later than ,january #ca1 #bjba1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report containing the results of the review described in paragraph 7#a74 ,such report shall analyze the value1 efficiency1 and effectiveness of reporting methods under subsections 7a7 and 7b7 of section #eai of ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;i7 and identify any recommendations for statutory amendments that would enhance the objectives of section #eai7;a7 of such ,act4