[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3580 Introduced in House (IH)]







107th CONGRESS
  1st Session
                                H. R. 3580

To amend the Federal Food, Drug, and Cosmetic Act to make improvements 
     in the regulation of medical devices, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           December 20, 2001

  Mr. Greenwood (for himself, Ms. Eshoo, Mr. Upton, Mr. Pallone, Mr. 
Deutsch, Mr. Towns, Mr. Bryant, and Mr. Barton of Texas) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to make improvements 
     in the regulation of medical devices, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE AND REFERENCE TO ACT.

    (a) Short Title.--This Act may be cited as the ``Medical Device 
Amendments of 2001''.
    (b) Reference.--Whenever in this Act an amendment or repeal is 
expressed in terms of an amendment to, or repeal of, a section or other 
provision, the reference shall be considered to be made to a section or 
other provision of the Federal Food, Drug, and Cosmetic Act.

SEC. 2. DESIGNATION AND REGULATION OF COMBINATION AND SINGLE ENTITY 
              PRODUCTS.

    Section 503(g) is amended by redesignating paragraph (4) as (5) and 
inserting after paragraph (3) the following paragraph:
    ``(4)(A) Within six months after the date of the enactment of the 
Medical Device Amendments of 2001, the Secretary shall establish within 
the Office of the Commissioner of Food and Drugs an office to be known 
as the Office of Combination Products and Product Jurisdiction 
(referred to in this paragraph as the `Office'), which shall be 
responsible for designating the Center with primary or exclusive 
responsibility for the premarket and postmarket regulation of drugs, 
devices and biological products. The Office shall be managed by a 
person with appropriate scientific expertise and shall oversee the 
regulation of such products to ensure timely and effective premarket 
reviews, and predictable and consistent postmarket requirements.
    ``(B) The Office shall assign for regulation all products subject 
to this Act based on the primary mode of action. The component within 
the Food and Drug Administration with primary or exclusive 
responsibility for regulating a product shall be determined according 
to the requirements of subparagraphs (A) through (C) of paragraph (1). 
All products which meet the definition of device or drug within the 
meaning of section 201, or biological product as defined under section 
351(i) of the Public Health Service Act shall be regulated only by the 
persons within the Food and Drug Administration who are primarily 
charged with the regulation of such products. In vitro reagents, as 
that term is used in section 201(h), shall be regulated by those 
persons within the Food and Drug Administration primarily charged with 
reviewing devices.
    ``(C)(i) The assignment of a product to a component of the Food and 
Drug Administration shall be for purposes of premarket and postmarket 
regulation.
    ``(ii) After such an assignment, all persons associated with shared 
premarket reviews, including reviews with input from a consulting 
agency component or reviews in which more than one premarket clearance 
is necessary, shall be responsible to and under the supervision of the 
Office for purposes of such reviews.
    ``(iii) Any disputes regarding the timeliness or substance of such 
reviews may be presented to the Office for resolution. The decision of 
the Office shall be subject exclusively to review by the Commissioner 
of Food and Drugs and such review shall not be delegated.
    ``(iv) The postmarket regulatory requirements for combination 
products shall be under the same type of product authorities as those 
relied upon to approve, clear, or license such products, unless two 
types of product authorities are necessary to permit the commercial 
distribution of a combination product. When more than one type of 
product authority is necessary to permit the commercial distribution of 
a combination product, each component of such product shall be subject 
to the postmarket requirements of the regulatory authority relied upon 
to permit the commercial distribution of each such component comprising 
the combination product.
    ``(D) The Office shall not be bound by any existing agreement, 
guidance or agency practice recommending assignment or assigning any 
device, drug, biological product, or combination product to any 
component of the Food and Drug Administration, unless the product is 
assigned to the agency component primarily charged with regulating each 
such product. The Office shall review each agency agreement, guidance 
or practice and determine whether they are consistent with the 
requirements of this subsection. As part of the review process, the 
Office shall publish for comment each such agreement, guidance or 
statement of practices. After receipt and analysis of comments, the 
Office shall determine whether to adopt, and to what extent, any of the 
agency's existing agreements, guidance documents or practices.
    ``(E) One year after the date of the enactment of the Medical 
Device Amendments of 2001 and for each year thereafter, the Secretary 
shall report to the appropriate committees of Congress the 
accomplishments, including the impact on the efficiency and quality of 
product regulation, of the Office. Among other things, such report 
shall describe the activities of the Office, identify the number of 
premarket reviews involving more than one review component of the Food 
and Drug Administration, discuss the timeliness and consistency of 
combination product premarket reviews, and demonstrate the Office's 
progress or lack of progress in ensuring timely and effective reviews 
of such products.''.

SEC. 3. STRENGTHENING THIRD PARTY REVIEW OF PREMARKET NOTIFICATION.

    Section 523 (21 U.S.C. 360m) is amended--
            (1) in subsection (a), by striking paragraph (3) and 
        inserting the following:
            ``(3) Eligible devices.--
                    ``(A) In general.--Each type of device subject to 
                the requirement of premarket notification under section 
                510(k) shall be eligible for review by persons 
                accredited under subsection (a), unless the Secretary 
                after notice and comment promulgates a regulation 
                excluding a type of device or specific devices within a 
                type from review by accredited persons under this 
                section.
                    ``(B) Exception.--Any type of device or specific 
                device that was eligible for premarket notification 
                review by persons accredited under this section six 
                months prior to the date of the enactment of the 
                Medical Device Amendments of 2001 shall continue to be 
                eligible for such review, unless the Secretary 
                determines that premarket notification by the Secretary 
                is necessary to assure reasonable assurance of safety 
                and effectiveness. After making this determination, the 
                Secretary shall promulgate a regulation after notice 
                and comment rulemaking to exclude such a type of device 
                or specific device from review under this section.''; 
                and
            (2) by striking subsection (c).

SEC. 4. AUGMENTING EXPERTISE.

    (a) Center for Devices Fellowship Program.--The Federal Food, Drug 
and Cosmetic Act is amended by adding at the end the following:

``SEC. 908. DEVICES FELLOWSHIP PROGRAM.

    ``(a) In General.--Without regard to the provisions of title 5, 
United States Code, governing appointments in the competitive service 
and without regard to the provisions of chapter 51 and subchapter III 
of chapter 53 of such title relating to classification and General 
Schedule pay rates, the Commissioner of Food and Drugs may establish a 
fellowship program within the component of the agency responsible for 
regulating devices for the purpose of augmenting and enriching the 
scientific expertise of that agency component. Any person receiving 
such a fellowship shall be available to participate in any matter in 
which the participation of such person would not create a conflict of 
interest, and shall be subject to the same requirements applicable to 
full time employees regarding the protection and use of trade secret 
and confidential commercial or financial information.
    ``(b) Eligibility.--Any qualified person not an employee of the 
Federal or a state government may be eligible for the fellowship 
identified in subsection (a). The granting of a fellowship to the 
candidate shall be the result of the unanimous agreement of a group of 
five (5) senior officials designated by the Commissioner, including at 
least three from the component of the Food and Drug Administration 
responsible for regulating devices. These officials shall evaluate the 
technical background and achievements of each candidate, the 
significance of the candidate's expertise to the agency's needs, and 
the candidate's character and likely contributions to the agency.''.
    (b) Outside Expert Reviews.--Section 515(c) (21 U.S.C. 360e(c) is 
amended by adding at the end the following:
    ``(3)(A) Either at the initiation of the Secretary or the 
applicant, any person who is (i) not an employee of the Federal or a 
state government, and (ii) an expert in a subject matter germane to an 
application under paragraph (1) may be selected by the Secretary to 
review all or part of a premarket approval application submitted under 
this section, after considering recommendations of experts from 
applicants, if any. The decision to use such an expert shall be made by 
agreement between the Secretary and the applicant, and the applicant 
may choose not to retain an expert for any reason, including the cost 
of the expert's compensation. The compensation for such an expert 
review shall be determined by the expert and the applicant.
    ``(B) The Secretary shall prescribe the terms of the review, 
including the amount of time allocated to such experts to submit to the 
Secretary and the applicant a report and recommendation evaluating that 
portion of the application the Secretary designated for review.
    ``(C) The Secretary shall promptly consider the recommendation of 
an expert reviewer and provide a detailed written explanation of any 
portion of the recommendation with which the Secretary disagrees.''.
    (c) Inspections by Accredited Persons.--Section 704 (21 U.S.C. 374) 
is amended by adding at the end the following:
    ``(g)(1) Not later than one year after the date of the enactment of 
the Medical Device Amendments of 2001, the Secretary shall accredit 
persons to conduct inspections authorized under subsection (a) at 
facilities designated as eligible for inspections by accredited persons 
who are not employees of the Federal or a state government. The owner 
or operator of an eligible facility shall have the option to use an 
accredited person in lieu of officers or employees designated by the 
Secretary to conduct such inspections, including inspections to satisfy 
the good manufacturing practice requirements of section 515.
    ``(2) Not later than 180 days after the date of the enactment of 
the Medical Device Amendments of 2001, the Secretary shall publish in 
the Federal Register criteria to accredit or deny accreditation to 
persons who request to perform the duties specified in paragraph (1). 
Thereafter, the Secretary shall respond to a request for accreditation 
within 60 days of the receipt of a request. The accreditation shall 
state that such person is accredited to conduct device facility 
inspections under subsection (a).
    ``(3) An accredited person shall, at a minimum, meet the following 
requirements:
            ``(A) Such person shall be an independent organization 
        which is not owned or controlled by a manufacturer, supplier, 
        or vendor of articles regulated under the Act and which has no 
        organizational, material, or financial affiliation with such a 
        manufacturer, supplier, or vendor.
            ``(B) Such person shall be a legally constituted entity 
        permitted to conduct the activities for which it seeks 
        accreditation.
            ``(C) Such person shall not engage in the design, 
        manufacture, promotion, or sale of articles regulated under the 
        Act.
            ``(D) The operations of such person shall be in accordance 
        with generally accepted professional and ethical business 
        practices and such persons shall agree in writing that as a 
        minimum it will--
                    ``(i) certify that reported information accurately 
                reflects data reviewed;
                    ``(ii) limit work to that for which competence and 
                capacity are available;
                    ``(iii) treat information received, records, 
                reports, and recommendations as confidential commercial 
                or financial information or trade secret information; 
                and
                    ``(iv) protect against the use, in carrying out 
                paragraph (1), of any officer or employee of the 
                accredited person who has a financial conflict of 
                interest regarding any product regulated under the Act, 
                and annually make available to the public disclosures 
                of the extent to which the accredited person, and the 
                officers and employees of the person, have maintained 
                compliance with requirements under this clause relating 
                to financial conflicts of interest.
    ``(4) The Secretary shall publish a list of accredited persons to 
conduct inspections under subsection (a) on the Food and Drug 
Administration's web page. Those who elect to employ an accredited 
person shall select such a person from the list posted by the 
Secretary. Such list shall be periodically updated to ensure that the 
identity of each accredited person is known to the public. The updating 
of such list shall be no later than one month after the accreditation 
of a person under this subsection.
    ``(5) To ensure that persons accredited under this subsection 
continue to meet the standards of accreditation, the Secretary shall 
(i) audit the performance of such persons on a periodic basis; and (ii) 
take such additional measures as the Secretary deems appropriate, 
including the withdrawal of accreditation when persons accredited under 
this subsection fail to maintain compliance with the accreditation 
criteria established by the Secretary.
    ``(6) Device facilities in which the Secretary classified the 
results of the facility's most recent inspection under subsection (a) 
as ``no action indicated'' or ``voluntary action indicated'', or those 
facilities in which after the most recent inspection, the Secretary 
determines that satisfactory compliance with section 520(f) supports 
the approval of a device under section 515, shall be eligible for 
inspections by persons accredited by the Secretary under paragraph (2). 
The Federal Food and Drug Administration shall not inspect an eligible 
facility unless--
            ``(A) the facility is not inspected by an accredited person 
        for the 2 year period following the date of a ``no action 
        indicated'' or ``voluntary action indicated'' finding by the 
        Secretary;
            ``(B) after an inspection by the Secretary, or after the 
        Secretary's review of a report of an inspection from an 
        accredited person, the Secretary determines in writing that a 
        facility is no longer eligible for inspections by accredited 
        persons; or
            ``(C) the Secretary has good cause for conducting an 
        inspection.
    ``(7) Persons accredited under this subsection to conduct 
inspections shall record in writing their inspection observations and 
shall present to the device facility's designated representative and 
discuss each observation. Additionally, such accredited person shall 
prepare an inspection report in a form and manner consistent with such 
reports prepared by employees and officials designated by the Secretary 
to conduct inspections under subsection (a). At a minimum, such reports 
shall identify the persons responsible for good manufacturing practice 
compliance at an inspected establishment, discuss in detail each 
observation identified by the accredited person, identify other matters 
that relate or may influence compliance with the Act, and discuss any 
recommendations made during the inspection or at the inspection's 
closing meeting. The report of the inspection shall be sent to the 
Secretary and the designated representative of an inspected facility at 
the same time, but under no circumstances later than 3 weeks after the 
last day of the inspection.
    ``(8) Compensation for an accredited person shall be determined by 
agreement between the accredited person and the person who engages the 
services of the accredited person, and shall be paid by the person who 
engages such services.''.

SEC. 5. SPECIAL PROCESS FOR BREAKTHROUGH TECHNOLOGIES.

    Section 515(d)(5) (21 U.S.C. 360e(d)(5)) is amended--
            (1) by redesignating subparagraphs (A) through (D) as 
        clauses (i) through (iv), respectively;
            (2) by inserting ``(A)'' after ``(5)''; and
            (3) by adding at the end the following subparagraph:
    ``(B)(i) In order to provide patients with the benefits of devices 
referenced in subparagraph (A) in the treatment and diagnosis of 
serious diseases or conditions, the Secretary shall within six months 
after the date of the enactment of the Medical Device Amendments of 
2001 promulgate a regulation setting forth a process to designate 
devices as `priority devices'. Such regulation shall include, among 
other things, requirements for (I) the specification of the contents of 
submissions requesting priority status; (II) a meeting to fully discuss 
the submission; (III) a written response no later than 30 days after 
the receipt of a submission granting or denying priority status; and 
(IV) an administrative appeal before the director or a deputy director 
of the Office of Device Evaluation, or any successor unit, within 10 
days of a written determination denying a device a priority 
designation. A request for a priority device designation may be made at 
any time, including times prior to the investigation of a device.
    ``(ii) A device which the Secretary designates as a priority device 
shall be subject to a review period of no longer than 120 days 
following the designation determination, at which time the Secretary 
shall approve or deny the application submitted to support approval of 
the device. The determination to approve or deny a premarket 
application for a priority device shall take into consideration the 
following in determining a reasonable assurance of device safety and 
effectiveness:
            ``(I) Whether the likely risk to expected health of 
        patients is less from using a priority device than the risk of 
        not having the device available to treat or diagnose a disease 
        or condition.
            ``(II) Whether the amount of benefit from a priority device 
        would exceed the benefit for an individual patient relative to 
        no treatment or diagnosis, or to alternative means of treatment 
        or diagnosis.
            ``(III) A comparison of risk to benefit as described in 
        subclauses (I) and (II), respectively.
    ``(iii)(I) The Secretary, in the context of a meeting under section 
520(g)(7), shall agree, when appropriate, to review data at an interim 
point in a clinical trial for purposes of determining reasonable 
assurance of device safety and effectiveness. Such interim reviews 
shall be subject to the conditions that the Secretary deems 
appropriate, including that the approval will become null and void if 
it is demonstrated at a consultation with the Director of the Office of 
Device Evaluation (or any successor unit) that the conclusions based on 
data from the completed clinical trial are inconsistent with those from 
the interim analysis and such conclusions would have resulted in denial 
of the application.
    ``(II) The Secretary shall rely on appropriate endpoints, including 
surrogate endpoints, when evaluating an application for a priority 
device to determine whether there exists a reasonable assurance of 
safety and effectiveness.
    ``(iv) To ensure a complete, fully informed and timely review of 
applications for priority devices, the Secretary shall include in the 
regulation referenced in subparagraph (B)(i) a provision requiring 
persons responsible for reviewing applications for such devices to meet 
with applicants to jointly consider such applications. Such meetings 
shall commence not later than the ninetieth day after receipt of an 
application that satisfies the criteria for completeness set forth in 
subsection (c). Such meetings shall provide adequate time for 
applicants and government employees to review an entire submission to 
ensure that applicants can quickly and effectively supplement 
applications for priority devices.''.

SEC. 6. INCREASING REPORTING EFFECTIVENESS.

    Section 519(a)(1) (21 U.S.C. 360i(a)(1)) is amended by inserting 
after and below subparagraph (B) the following:
        ``except that such reports shall only be required when the 
        Secretary identifies a type of device in the Federal Register 
        for which the Secretary intends to require malfunction 
        reporting, which malfunction reporting shall be in effect after 
        a 60 day comment period and the Secretary's Federal Register 
        announcement that a type of device is subject to such 
        reporting, and which malfunction reporting shall be on a 
        quarterly basis, and shall be limited to information describing 
        the device and the event, the date and location of the event, 
        and the identity of the person at the facility or place where 
        the event occurred upon whom the reporter relied for 
        information;''.

SEC. 7. INDICATIONS FOR USE.

    (a) Premarket Notification Proposed Intended Use.--Section 
513(i)(1)(E) (21 U.S.C. 360c(i)(1)(E)) is amended by striking clause 
(iv).
    (b) Premarket Approval Proposed Conditions of Use.--Section 
515(d)(1)(A) (21 U.S.C. 360e(d)(1)(A)) is amended by adding at the end 
the following: ``Whenever the Secretary determines that proposed 
labeling is false or misleading, the Secretary shall, no later than 150 
days after receipt of an application filed under subsection (c), notify 
the applicant in writing of the basis for such a determination.''.
    (c) Supplements for Certain Conditions of Use.--Section 515(d)(6) 
(21 U.S.C. 360e(d)(6)) is amended by adding at the end the following 
subparagraph:
    ``(C)(i) Subject to clause (ii), in reviewing any supplement to an 
approved application, which is submitted to obtain the additional 
specification of a subpopulation under an approved condition of use, 
the Secretary shall approve such supplement without additional clinical 
data when--
            ``(I) the underlying conditions of use of the device are 
        otherwise unchanged from that approved by the Secretary; and
            ``(II) preclinical and clinical data exist in the approved 
        application applicable to the safe and effective use of the 
        device in the specified subpopulation, or a bona fide peer 
        review journal article reporting clinical experience with the 
        device in the subpopulation demonstrates that there is 
        reasonable assurance of the device's safety and effectiveness.
    ``(ii) In evaluating an indication for such a patient 
subpopulation, the Secretary may require, when necessary, the 
submission of clinical data to determine whether there is a reasonable 
assurance of safety and effectiveness.''.

SEC. 8. IMPROVING COLLABORATION.

    (a) Least Burdensome Determinations.--Section 513(a)(3)(D) (21 
U.S.C. 360c(a)(3)(D)) is amended--
            (1) in clause (i), by inserting ``within 20 days of such a 
        request'' after ``section 515, shall''; and
            (2) by striking clause (ii) and inserting the following:
    ``(ii) Any clinical data and other valid scientific evidence, 
specified in writing by the Secretary to demonstrate reasonable 
assurance of device effectiveness shall represent a determination by 
the Secretary that such evidence is the least burdensome information 
necessary to satisfy a finding of effectiveness for purposes of 
approving a device under subsection 515(d).''.
    (b) Investigational Plan Agreement Meetings.--Section 520(g)(7) (21 
U.S.C. 360j(g)(7)) is amended--
            (1) in subparagraph (A)--
                    (A) by striking the first sentence and inserting 
                the following: ``In the case of a person intending to 
                investigate the safety and effectiveness or substantial 
                equivalence of a device, and such investigation 
                includes the undertaking of a clinical trial, the 
                Secretary shall ensure that such person has an 
                opportunity, prior to submitting an application under 
                section 515 or a premarket notification under section 
                510(k) to the Secretary or an institutional review 
                committee, to submit to the Secretary an 
                investigational plan (including a clinical protocol) 
                for review.''; and
                    (B) by striking the last sentence and inserting the 
                following: ``The written request shall include a 
                detailed description of the device, including the 
                device's proposed indications or conditions of use, and 
                a proposed investigational plan or any part of such 
                plan to which the submitter seeks review and 
                agreement.''; and
            (2) in subparagraph (B), in the matter preceding clause 
        (i), by inserting after ``applicant shall'' the following: 
        ``reflect the least burdensome information necessary to support 
        an approval under section 515 or a substantial equivalence 
        determination under section 513(f)(1), and shall''.
    (c) Improving Interim PMA Review Meetings.--Section 515(d)(3)(A) 
(21 U.S.C. 360e(d)(3)(A)) is amended--
            (1) in clause (i), by inserting at the end the following: 
        ``The term application, as used in this paragraph, shall 
        include any submission made under this section, or regulations 
        implementing this section, which is subject to a 180 day review 
        period.''; and
            (2) in clause (ii), by inserting at the end the following: 
        ``The written identification of deficiencies and the specific 
        information that is required to correct such deficiencies shall 
        be provided to the applicant no later than 10 days prior to the 
        meeting.''.

SEC. 9. GUIDANCE.

    (a) In General.--Section 701(h)(1)(C) (21 U.S.C. 371(h)(1)(C)) is 
amended--
            (1) by inserting ``(i)'' after ``(C)''; and
            (2) by adding at the end the following:
    ``(ii)(I) After a request for participation from individuals or 
groups not employed or associated with Federal or State governments to 
participate in the development of specific guidance or policy 
documents, the Secretary shall meet with such individuals or groups to 
obtain input into the guidance development process when such persons or 
groups have expertise germane to the subject matter of potential 
guidance or policy documents and, in the opinion of the Secretary, such 
persons or groups can provide information that will enhance the 
Secretary's public health assessment of the impact of a potential 
guidance or policy document.
    ``(II) Any request under subclause (I) shall identify the 
expertise, and relevance of such expertise, to the development of a 
guidance or policy document, or the information that would justify a 
meeting because of the expected benefit to the public health resulting 
from such information.
    ``(III) Each meeting with an individual or group under subclause 
(I) shall be promptly identified through publication of the Secretary's 
calendar.''.

SEC. 10. MODULAR REVIEW.

    Section 515(c) (21 U.S.C. 360e(c)), as amended by section 4(b) of 
this Act, is further amended by adding at the end the following:
    ``(4)(A) Prior to the submission of an application under this 
subsection, the Secretary shall accept and review portions of such 
applications that applicants and the Secretary agree are complete and 
ready for review.
    ``(B) Each portion of a submission reviewed under subparagraph (A) 
and found acceptable by the Secretary shall not be further reviewed 
after receipt of an application that satisfies the requirements of 
paragraph (1), unless new information provides the Secretary cause to 
review such accepted portion.
    ``(C) Whenever the Secretary determines that a portion of a 
submission under subparagraph (A) is unacceptable, the Secretary shall 
specifically identify, in writing, the deficiency of such portion and 
describe in detail the means by which it may be made acceptable.''.

SEC. 11. REGISTRATION.

    (a) In General.--Section 510(b) (21 U.S.C. 360(b)) is amended to 
read as follows:
    ``(b)(1) Every second year after initially registering, every 
person who owns or operates any establishment in any State, territory, 
or foreign country engaged in the manufacture, preparation, 
propagation, compounding, or processing of a drug or drugs or a device 
or devices shall register with the Secretary his name, place of 
business, and such establishment.
    ``(2) Every person who registers under this section shall update 
such person's registration information within 30 days of any change or 
event, when information about such change or event is required by 
regulations promulgated by the Secretary.
    ``(3) Initial registrations and registration updates shall be 
submitted to the Secretary by electronic means, unless the Secretary 
grants a request for waiver of this requirement because use of 
electronic communications is not reasonable for the regulated person 
requesting such waiver.''.
    (b) Conforming Amendment.--Section 510(d) (21 U.S.C. 360(d)) is 
amended by striking ``immediately''.

SEC. 12. ELECTRONIC LABELING.

    Section 201(m) (21 U.S.C. 321(m)) is amended by adding at the end 
the following: ``For purposes of providing adequate directions for use, 
labeling may also include written, printed, or graphic matter which is 
displayed by electronic means and is intended as labeling by the person 
responsible for labeling an article.''.
                                 <all>