A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications.

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.

Summary: 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.