text: SECTION 1. FINDINGS.
  
      Congress finds as follows:
              (1) There is a lack of transparency and consistency 
          concerning inspections by the Food and Drug Administration of 
          medical device establishments around the world, which leads to 
          inefficiencies and inconsistencies and undermines confidence in 
          United States standards.
              (2) Inspections by the Food and Drug Administration of 
          foreign device establishments are often conducted more 
          efficiently than inspections of domestic device establishments.
              (3) The frequency and nature of inspections of device 
          establishments are not consistently risk-based, and a 
          comprehensive, transparent, risk-based approach to inspections 
          would result in greater focus on the more significant risks to 
          public health while reducing the burdens on establishments with 
          a strong track record of compliance.
              (4) There is a lack of transparency and consistency among 
          United States-based regional inspection offices with respect to 
          the frequency of inspections of device establishments and the 
          activities and concerns that trigger for-cause inspections of 
          such establishments.
              (5) Greater transparency concerning the timing and nature 
          of routine inspections of device establishments would improve 
          the quality and efficiency of the inspection process.
              (6) Enhancing communications before, during, and after 
          inspections in which deficiencies are identified, would assist 
          the Secretary of Health and Human Services and the device 
          industry in maintaining the safety and effectiveness of 
          devices.
              (7) Guidance for device establishments is necessary to 
          provide transparency and consistency concerning inspection-
          related communications.
              (8) Enhanced training opportunities for device 
          establishment investigators would improve the consistency and 
          efficiency of the device inspection process.
              (9) There is a lack of transparency in the export 
          certification process with respect to device establishments for 
          which FDA Form 483 has been used to document issues noticed 
          during an inspection conducted pursuant to section 704 of the 
          Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) or 
          establishments that have received Warning Letters in connection 
          with such an inspection, and between domestic and foreign 
          establishments, resulting in devices that are lawfully marketed 
          for United States patients being denied certification for 
          marketing in other countries.
              (10) Device establishments that have attempted to address 
          deficiencies identified by inspections carried out by the Food 
          and Drug Administration lack sufficient opportunities to 
          confirm that such corrective actions are appropriate.
  
  SEC. 2. RISK-BASED INSPECTIONS FOR DEVICES.
  
      Paragraph (2) of section 510(h) of the Federal Food, Drug, and 
  Cosmetic Act (21 U.S.C. 360(h)) is amended to read as follows:
              ``(2) Risk-based schedule for devices.--
                      ``(A) In general.--The Secretary, acting through 
                  one or more officers or employees duly designated by 
                  the Secretary, shall inspect establishments described 
                  in paragraph (1) that are engaged in the manufacture, 
                  propagation, compounding, or processing of a device or 
                  devices (referred to in this subsection as `device 
                  establishments') in accordance with one risk-based 
                  inspection schedule established by the Secretary, 
                  applied consistently across regional offices.
                      ``(B) Factors and considerations.--In establishing 
                  the risk-based schedule under subparagraph (A), the 
                  Secretary shall--
                              ``(i) apply, to the extent applicable for 
                          device establishments, the factors identified 
                          in paragraph (4); and
                              ``(ii) consider the participation of the 
                          device establishment, as applicable, in 
                          international device audit programs in which 
                          the United States participates or the United 
                          States recognizes for purposes of 
                          inspecting.''.
  
  SEC. 3. IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE ESTABLISHMENTS.
  
      Section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
  374) is amended by adding at the end the following:
      ``(h)(1) The Secretary shall adopt a uniform process and uniform 
  standards applicable to inspections of domestic and foreign device 
  establishments. Such process shall include--
              ``(A) notifying the owner, operator, or agent in charge of 
          the establishment of the type and nature of the inspection;
              ``(B) announcing the inspection the establishment within a 
          reasonable time before such inspection;
              ``(C) in the case of inspections other than for-cause 
          inspections, providing a reasonable estimate of the timeframe 
          for the inspection, an opportunity for advance communications 
          between the officers or employees carrying out the inspection 
          under subsection (a)(1) and the owner, operator, or agent in 
          charge of the establishment concerning appropriate working 
          hours during the inspection, and, to the extent feasible, 
          advance notice of records that will be requested in order to 
          expedite the inspection; and
              ``(D) daily communications with the owner, operator, or 
          agent in charge of the establishment regarding inspection 
          status, which may be recorded by either party with advance 
          notice.
      ``(2) In the case of device establishments that have received a 
  report pursuant to subsection (b), and for which the owner, operator, 
  or agent in charge of such establishment submits a timely response to 
  such report that includes a request for feedback to the actions 
  proposed in such response, the Secretary shall provide nonbinding 
  feedback regarding such proposed actions within 45 days of receipt of 
  such request.
      ``(3) Nothing in this subsection limits the authority of the 
  Secretary to conduct inspections otherwise permitted under this Act in 
  order to ensure compliance with this Act.
      ``(4)(A) Not later than 1 year after the date of enactment of this 
  subsection, the Secretary shall issue draft guidance that--
              ``(i) specifies how the Food and Drug Administration will 
          implement the process described in paragraph (1) and the 
          requirements described in paragraph (2);
              ``(ii) provides for standardized templates for 
          communications described in such paragraphs;
              ``(iii) establishes a standard timeframe over consecutive 
          days that is applicable to both domestic and foreign 
          inspections, to which each inspector shall adhere unless an 
          investigator can identify to the establishment a reason that 
          more time is needed; and
              ``(iv) identifies practices for investigators and device 
          establishments to facilitate the continuity of inspections.
      ``(B) Not later than 18 months after the date of enactment of this 
  subsection, after notice and opportunity for public comment on the 
  draft guidance described in subparagraph (A), the Secretary shall issue 
  final guidance consistent with this subsection.''.
  
  SEC. 4. CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES.
  
      Subsection (e)(4) of section 801 of the Federal Food, Drug, and 
  Cosmetic Act (21 U.S.C. 381(e)(4)) is amended--
              (1) by adding at the end the following:
      ``(E)(i) If the Secretary denies a request for certification with 
  respect to a device pursuant to subparagraph (A)(ii), the Secretary 
  shall provide in writing to the person seeking such certification the 
  basis for such denial, and specifically identify the finding upon which 
  such denial is based.
      ``(ii) If the denial of a request as described in clause (i) is 
  based on grounds other than an injunction proceeding pursuant to 
  section 302, seizure action pursuant to section 304, or a recall 
  designated Class I or Class II pursuant to part 7, title 21, Code of 
  Federal Regulations, the Secretary shall provide a substantive summary 
  of the specific deficiencies identified.
      ``(iii) With respect to a device manufactured in an establishment 
  that has received a report under section 704(b), the Secretary shall 
  not deny a request for certification with respect to a device pursuant 
  to subparagraph (A)(ii) if the Secretary and the owner, operator, or 
  agent in charge of such establishment have agreed to a plan of 
  correction in response to such report.
      ``(F)(i) The Secretary shall provide a process for a person who is 
  denied a certification as described in subparagraph (E)(i) to request a 
  review that conforms to the standards of section 517A(b).
      ``(ii) Notwithstanding any previous review conducted pursuant to 
  clause (i), a person who has been denied a certification as described 
  in subparagraph (E)(i) may at any time request a review in order to 
  present new information relating to actions taken by such person to 
  address the reasons identified by the Secretary for the denial of 
  certification, including corrective actions to address deficiencies 
  identified by the Secretary.
      ``(iii) Not later than 1 year after date of enactment of this 
  subparagraph, the Secretary shall issue guidance providing for a 
  process to carry out this subparagraph.
      ``(G)(i) Subparagraphs (E) and (F) apply to requests for 
  certification on behalf of any device establishment registered under 
  section 510, whether the establishment is located in the United States 
  or another country.
      ``(ii) The Secretary may charge a fee for the issuance of a 
  certification described in clause (i), and such fee is subject to the 
  conditions and requirements of subparagraph (B).''; and
              (2) by moving the margins of subparagraphs (C) and (D) 4 
          ems to the left.
target: This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding Food and Drug Administration (FDA): (1) inspections of establishments that manufacture or process medical devices, and (2) certification of medical devices for export. The biannual inspection schedule for medical device establishments handling higher risk devices is replaced with a risk-based schedule. In establishing the risk-based schedule, the FDA must consider an establishment's participation in international medical device audit programs. The FDA must adopt a uniform process and uniform standards for inspections of domestic and foreign medical device establishments. Upon request, the FDA must provide to the person in charge of a medical device establishment feedback regarding the person's proposals to address issues identified during an inspection. The FDA must provide the basis for denying requests for certification of products for export as meeting FDA requirements for domestic products. A person denied such a certification may request supervisory review of that decision. Products from a medical device establishment that an inspector found to be contaminated or insanitary may be certified for export if the person in charge of the establishment has agreed to a plan to correct the issues identified during the inspection.
feat_title: A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications.