text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``Improving Medical Device Innovation 
  Act''.
  
  SEC. 2. RECOGNITION OF STANDARDS.
  
      (a) In General.--Section 514(c) of the Federal Food, Drug, and 
  Cosmetic Act (21 U.S.C. 360d(c)) is amended--
              (1) in paragraph (1), by inserting after subparagraph (B) 
          the following new subparagraphs:
                      ``(C)(i) Any person may submit a request for 
                  recognition under subparagraph (A) of all or part of an 
                  appropriate standard established by a nationally or 
                  internationally recognized standard organization.
                      ``(ii) Not later than 60 calendar days after the 
                  Secretary receives such a request, the Secretary 
                  shall--
                              ``(I) make a determination to recognize 
                          all, part, or none of the standard that is the 
                          subject of the request; and
                              ``(II) issue to the person who submitted 
                          such request a response in writing that states 
                          the Secretary's rationale for that 
                          determination, including the scientific, 
                          technical, regulatory, or other basis for such 
                          determination.
                      ``(iii) The Secretary shall take such actions as 
                  may be necessary to implement all or part of a standard 
                  recognized under subclause (I) of clause (ii), in 
                  accordance with subparagraph (A).
                      ``(D) The Secretary shall make publicly available, 
                  in such manner as the Secretary determines appropriate, 
                  the rationale for recognition of all, part, or none of 
                  a standard, including the scientific, technical, 
                  regulatory, or other basis for the decision regarding 
                  such recognition.''; and
              (2) by adding at the end the following:
              ``(4) 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 Act, including standards relevant to an 
          employee's area of device review.''.
      (b) Guidance.--The Secretary of Health and Human Services, acting 
  through the Commissioner of Food and Drugs, shall review and update, if 
  necessary, previously published guidance and standard operating 
  procedures identifying the principles for recognizing standards, and 
  for withdrawing the recognition of standards, under section 514(c) of 
  the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)), taking 
  into account the experience with and reliance on a standard by foreign 
  regulatory authorities and the device industry, and whether recognition 
  of a standard will promote harmonization among regulatory authorities 
  in the regulation of devices.
  
  SEC. 3. CERTAIN CLASS I AND CLASS II DEVICES.
  
      (a) Class I Devices.--Section 510(l) of the Federal Food, Drug, and 
  Cosmetic Act (21 U.S.C. 360(l)) is amended--
              (1) by striking ``A report under subsection (k)'' and 
          inserting ``(1) A report under subsection (k)''; and
              (2) by adding at the end the following new paragraph:
              ``(2) Not later than 120 calendar days after the date of 
          enactment of the Improving Medical Device Innovation Act and at 
          least once every 5 years thereafter, as the Secretary 
          determines appropriate, the Secretary shall identify, through 
          publication in the Federal Register, any type of class I device 
          that the Secretary determines no longer requires a report under 
          subsection (k) to provide reasonable assurance of safety and 
          effectiveness. Upon such publication--
                      ``(A) each type of class I device so identified 
                  shall be exempt from the requirement for a report under 
                  subsection (k); and
                      ``(B) the classification regulation applicable to 
                  each such type of device shall be deemed amended to 
                  incorporate such exemption.''.
      (b) Class II Devices.--Section 510(m) of the Federal Food, Drug, 
  and Cosmetic Act (21 U.S.C. 360(m)) is amended--
              (1) by striking paragraph (1) and inserting the following 
          new paragraph:
              ``(1) The Secretary shall--
                      ``(A) not later than 90 days after the date of 
                  enactment of the Improving Medical Device Innovation 
                  Act and at least once every 5 years thereafter, as the 
                  Secretary determines appropriate--
                              ``(i) 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 
                          (k) to provide reasonable assurance of safety 
                          and effectiveness; and
                              ``(ii) provide for a period of not less 
                          than 60 calendar days for public comment 
                          beginning on the date of the publication of 
                          such notice; and
                      ``(B) not later than 210 calendar days after the 
                  date of enactment of the Improving Medical Device 
                  Innovation Act, 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 (A).''; and
              (2) in paragraph (2)--
                      (A) by striking ``1 day after the date of 
                  publication of a list under this subsection,'' and 
                  inserting ``1 calendar day after the date of 
                  publication of the final list under paragraph 
                  (1)(B),''; and
                      (B) by striking ``30-day period'' and inserting 
                  ``60-calendar-day period''; and
                      (C) by adding at the end the following new 
                  paragraph:
              ``(3) Upon the publication of the final list under 
          paragraph (1)(B)--
                      ``(A) each type of class II device so listed shall 
                  be exempt from the requirement for a report under 
                  subsection (k); and
                      ``(B) the classification regulation applicable to 
                  each such type of device shall be deemed amended to 
                  incorporate such exemption.''.
  
  SEC. 4. CLASSIFICATION PANELS.
  
      (a) Classification Panels.--Paragraph (5) of section 513(b) of the 
  Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended--
              (1) by striking ``(5)'' and inserting ``(5)(A)''; and
              (2) by adding at the end the following:
                      ``(B) When a device is specifically the subject of 
                  review by a classification panel, the Secretary shall--
                              ``(i) ensure that adequate expertise is 
                          represented on the classification panel to 
                          assess--
                                      ``(I) the disease or condition 
                                  which the device is intended to cure, 
                                  treat, mitigate, prevent, or diagnose; 
                                  and
                                      ``(II) the technology of the 
                                  device; and
                              ``(ii) 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 panel.
                      ``(C) For purposes of subparagraph (B)(i), the term 
                  `adequate expertise' means that the membership of the 
                  classification panel includes--
                              ``(i) two or more voting members, with a 
                          specialty or other expertise clinically 
                          relevant to the device under review; and
                              ``(ii) at least one voting member who is 
                          knowledgeable about the technology of the 
                          device.
                      ``(D) The Secretary shall provide an annual 
                  opportunity for patients, representatives of patients, 
                  and sponsors of medical device submissions to provide 
                  recommendations for individuals with appropriate 
                  expertise to fill voting member positions on 
                  classification panels.''.
      (b) Panel Review Process.--Section 513(b)(6) of the Federal Food, 
  Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended--
              (1) in subparagraph (A)(iii), by inserting before the 
          period at the end ``, including by designating a representative 
          who will be provided a time during the panel meeting to address 
          the panel individually (or accompanied by experts selected by 
          such representative) for the purpose of correcting 
          misstatements of fact or providing clarifying information, 
          subject to the discretion of the panel chairperson''; and
              (2) by striking subparagraph (B) and inserting the 
          following new subparagraph:
                      ``(B)(i) Any meeting of a classification panel with 
                  respect to the review of a device shall--
                              ``(I) provide adequate time for initial 
                          presentations by the person whose device is 
                          specifically the subject of such review and by 
                          the Secretary; and
                              ``(II) provide adequate time for and 
                          encourage free and open participation by all 
                          interested persons.
                      ``(ii) Following the initial presentations 
                  described in clause (i), the panel may--
                              ``(I) pose questions to the designated 
                          representative described in subparagraph 
                          (A)(iii); and
                              ``(II) consider the responses to such 
                          questions in the panel's review of the 
                          device.''.
  
  SEC. 5. POSTMARKET PILOT TO IMPROVE MEDICAL DEVICE REPORTING.
  
      (a) Pilot Projects.--
              (1) In general.--In order to improve the value and 
          efficiency of reporting so as to advance the objectives of 
          section 519(a) of the Federal Food, Drug, and Cosmetic Act (21 
          U.S.C. 360i(a)), within one year of the date of enactment of 
          this Act, the Secretary of Health and Human Services shall 
          establish one or more pilot projects, in coordination with 
          device manufacturers, to explore and evaluate the use of 
          alternative methods of compliance with such subsection for 
          manufacturers of devices described in section 513(a)(1)(C) of 
          the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
          360c(a)(1)(C)).
              (2) Voluntary participation.--Participation in such pilot 
          projects shall be voluntary for device manufacturers. The 
          Secretary may establish the conditions for such voluntary 
          participation and may establish a process for authorizing 
          participation.
              (3) Purposes.--The pilot projects established under 
          paragraph (1) shall be designed to--
                      (A) test methods of reporting for one or more 
                  device types, with priority given to devices for which 
                  device manufacturers submit a relatively high volume of 
                  reports under the regulations implementing section 
                  519(a) of the Federal Food, Drug, and Cosmetic Act (21 
                  U.S.C. 360i(a));
                      (B) 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 
                  device;
                      (C) identify methods of reporting that will be 
                  least burdensome for device manufacturers; and
                      (D) evaluate methods that are alternative to, and 
                  do not duplicate, compliance with requirements of part 
                  803 of title 21, Code of Federal Regulations (or 
                  successor regulations).
              (4) Notification to congress.--The Secretary of Health and 
          Human Services shall notify the Committee on Health, Education, 
          Labor, and Pensions of the Senate and the Committee on Energy 
          and Commerce of the House of Representatives not later than 18 
          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 Services.
              (5) 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 803 of title 21, Code of Federal 
          Regulations (or successor regulations), including such methods 
          described in this subsection.
              (6) Compliance with requirements for records or reports on 
          devices.--
                      (A) 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 519 of the Federal Food, Drug, 
                  and Cosmetic Act (21 U.S.C. 360i), and implementing 
                  regulations, except as described in subparagraph (B).
                      (B) Conditional exemption.--The Secretary may 
                  determine that, for a specified time period to be 
                  determined by the Secretary, a manufacturer 
                  participating in a pilot project under this subsection 
                  is exempt from certain provisions of section 519(a) of 
                  the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                  360i(a)), and implementing regulations, if such 
                  manufacturer complies with the conditions set forth in 
                  a pilot project under this subsection.
      (b) GAO Review.--
              (1) Review of pilot projects.--The Comptroller General of 
          the United States shall conduct a review of the pilot projects 
          established under subsection (a), and of the reporting system 
          under part 803 of title 21, Code of Federal Regulations (or 
          successor regulations).
              (2) Report.--Not later than January 31, 2021, the 
          Comptroller General of the United States shall submit to 
          Congress a report containing the results of the review 
          described in paragraph (1). Such report shall analyze the 
          value, efficiency, and effectiveness of reporting methods under 
          subsections (a) and (b) of section 519 of Federal Food, Drug, 
          and Cosmetic Act (21 U.S.C. 360i) and identify any 
          recommendations for statutory amendments that would enhance the 
          objectives of section 519(a) of such Act.
target: Improving Medical Device Innovation Act This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions related to medical device performance standards, reporting requirements, and classification panels. A person may request that the Food and Drug Administration (FDA) recognize a performance standard established by a recognized standards organization as a standard to which a medical device may conform in order to meet an FDA requirement. When a request to recognize a standard is received, the FDA must determine whether to recognize all, part, or none of the standard and publish the rationale for that determination. (Currently, the FDA recognizes certain performance standards, but it is not required to respond to requests or publish rationales.) The FDA must:  train employees who review premarket submissions for medical devices on recognized standards; review its published principles for recognizing standards; identify types of medical devices for which a premarket report is no longer needed to provide reasonable assurance of safety and effectiveness; ensure that adequate expertise is represented on medical device classification panels; provide an opportunity for a person whose premarket submission is subject to review by a classification panel to recommend expertise needed on the panel; and provide opportunities for patients, patient representatives, and medical device sponsors to recommend individuals for positions on classification panels.  The FDA, in coordination with medical device manufacturers, must establish pilot projects to evaluate alternative methods of compliance with reporting requirements for certain medical devices. The Government Accountability Office must report on these pilot projects.
feat_title: Improving Medical Device Innovation Act