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PUBLIC LAW 101-629—NOV. 28, 1990 104 STAT. 4511
Public Law 101-
101st Congress
An Act
To amend the Federal Food, Drug, and C!osmetic 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 "Safe Medical Devices Act of 1990". 0?) REFERENCE.—Whenever in this Act (other than in section 19) 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. USER REPORTS. (a) REQUIREMENT.—Section 519 (21 U.S.C. 360i) is amended by redesignating subsection (b) as subsection (c) and by inserting after subsection (a) the following:
"User Reports
"(b)(1)(A) Whenever a device user facility receives or otherwise becomes aware of information that reasonably suggests that there is a probability that a device has caused or contributed to the death of a patient of the facility, the facility shall, as soon as practicable but not later than 10 working days after becoming aware of the informa- tion, report the information to the Secretary and, if the identity of the manufacturer is known, to the manufacturer of the device. In the case of deaths, the Secretary may by regulation prescribe a shorter period for the reporting of such information. "(B) Whenever a device user facility receives or otherwise becomes aware of information that reasonably suggests that there is a prob- ability that a device has caused or contributed to the serious illness of, or serious injury to, a patient of the facility, the facility shall, as soon as practicable but not later than 10 working days after becom- ing aware of the information, report the information to the manu- facturer of the device or to the Secretary if the identity of the manufacturer is not known. "(C) Each device user facility shall submit to the Secretary on a semi-annual basis a summary of the reports made under subpara- graphs (A) and (B). Such summary shall be submitted on January 1 and July 1 of each year. The summary shall be in such form and contain such information from such reports as the Secretary may require and shall include— "(i) sufficient information to identify the facility which made the reports for which the summary is submitted, "(ii) in the case of any product which was the subject of a report, the product name, serial number, and model number.
Nov. 28, 1990 [H.R. 3095]
Safe Medical Devices Act of
Health care. 21 u s e 301 note.
104 STAT. 4512 PUBLIC LAW 101-629—NOV. 28, 1990
"(iii) the name and the address of the manufacturer of such device, and "(iv) a brief description of the event reported to the manufac- turer. The Secretary may by regulation alter the frequency and timing of reports required by this subparagraph. "(D) For purposes of subparagraphs (A), (B), and (C), a device user facility shall be treated £is having received or otherwise become aware of information with respect to a device of that facility when medical personnel who are employed by or otherwise formally affiliated with the facility receive or otherwise become aware of information with respect to that device in the course of their duties. "(2) The Secretary may not disclose the identity of a device user facility which makes a report under paragraph (1) except in connec- tion with— "(A) an action brought to enforce section 301(q), "(B) a communication to a manufacturer of a device which is the subject of a report under paragraph (1), or "(C) a disclosure required under subsection (a). This paragraph does not prohibit the Secretary from disclosing the identity of a device user facility making a report under paragraph (1) or any information in such a report to employees of the Depart- ment of Health and Human Services, to the Department of Justice, or to the duly authorized committees and subcommittees of the Congress. "(3) No report made under paragraph (1) by— "(A) a device user facility, "(B) an individual who is employed by or otherwise formally affiliated with such a facility, or "(C) a physician who is not required to make such a report, shall be admissible into evidence or otherwise used in any civil action involving private parties unless the facility, individual, or physician who made the report had knowledge of the falsity of the information contained in the report. "(4) A report made under paragraph (1) does not affect any obligation of a manufacturer who receives the report to file a report as required under subsection (a). "(5) For purposes of this subsection: "(A) The term 'device user facility' means a hospital, ambula- tory surgical facility, nursing home, or outpatient treatment facility which is not a physician's office. The Secretary may by regulation include an outpatient diagnostic facility which is not a physician's office in such term. "(B) The terms 'serious illness' and 'serious injury' mean illness or injury, respectively, that— "(i) is life threatening, "(ii) results in permanent impairment of a body function or permanent damage to a body structure, or "(iii) necessitates immediate medical or surgical interven- tion to preclude permanent impairment of a body function or permanent damage to a body structure.". 21 use 360i (b) REGULATIONS.—The Secretary of Health and Human Services shall promulgate regulations to implement section 519(b) of the Federal Food, Drug, and Cosmetic Act, as added by the amendment made by subsection (a) (including a definition of the summary required by paragraph (1)(C) of such section) not later than 12 months after the date of enactment of this Act. In promulgating the
note.
104 STAT. 4514 PUBLIC LAW 101-629—NOV. 28, 1990
(1) Section 519(a) (21 U.S.C. 360i(a)) is amended by striking out "and" at the end of paragraph (4), by striking out the period at the end of paragraph (5) and inserting in lieu thereof "; and", and by adding after paragraph (5) the following: "(6) shall require distributors who submit such reports to submit copies of the reports to the manufacturer of the device for which the report was made.". Effective date. (2) Section 519(a)(6), as added by the amendment made by 21 use 360i paragraph (1), shall take effect upon the effective date of final regulations under subsection (c). (b) CERTIFICATION, DEVICE TRACKING.— (1) Section 519 (21 U.S.C. 360i), as amended by section 2, is amended by adding at the end the following:
"Certification
"(d) Each manufacturer, importer, and distributor required to make reports under subsection (a) shall submit to the Secretary annually a statement certifying that— "(1) the manufacturer, importer, or distributor did file a certain number of such reports, or "(2) the manufacturer, importer, or distributor did not file any report under subsection (a).
"Device Tracking
"(e) Every person who registers under section 510 and is engaged in the manufacture of— "(1) a device the failure of which would be reasonably likely to have serious adverse health consequences and which is (A) a permanently implantable device, or (B) a life sustaining or life supporting device used outside a device user facility, or "(2) any other device which the Secretary may designate, shall adopt a method of device tracking.". (2) Section 520(j) (21 U.S.C. 360j(j)) is amended by striking out "No" and inserting in lieu thereof "Except as provided in section 519(e), no". Effective (3) Section 519(e), as added by the amendment made by
9?*fTGr- Qcn- paragraph (1), shall take effect upon the effective date of final note regulations under subsection (c). 21 use 360i (c) REGULATIONS.— note. (1)(A) Not later than 9 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue proposed regulations— Records. (i) to require distributors of devices to establish and maintain records and to make reports (including reports required by part 803 of title 21 of the Code of Federal Regulations) under section 519(a)(6) of the Federal Food, Drug, and Cosmetic Act, and (ii) to implement section 519(e) of such Act. The Secretary may exempt from regulations described in clause (i) classes of distributors of class I and class II devices from whom reports are not necessary for the protection of the public health. (B) Regulations under subparagraph (A) shall—
PUBLIC LAW 101-629— NOV. 28, 1990 104 STAT. 4515
(i) require appropriate methods for maintenance of records to ensure that patients who receive devices can be provided the notification required by such Act, (ii) require that manufacturers adopt effective methods of tracking devices, (iii) take into account the position of distributors in the device distribution process, and (iv) include such other requirements as the Secretary deems necessary for the adoption of an effective user track- ing program under section 519(e) of such Act. (2) Not later than 18 months after the date of the enactment of this Act, the Secretary shall issue final regulations to imple- ment sections 519(a)(6) and 519(e) of the Federal Food, Drug, and Cosmetic Act. If the Secretary does not promulgate such final regulations upon the expiration of such 18 months, the Congress finds that there is good cause for the proposed regulations to be considered as the final regulations without response to com- ment because the implementation of sections 519(a)(6) and 519(e) of such Act are essential to protect the health of patients who use such devices. Consequently, in such event, the proposed regulations issued under paragraph (1) shall become final regu- lations as of the expiration of such 18 months. There shall be Federal promptly published in the Federal Register notice of the new pubiic|[-on status of the proposed regulations.
SEC. 4. SUBSTANTIAL EQUIVALENCE; CLASSIFICATION REVISION.
(a) SUBSTANTIAL EQUIVALENCE.—Section 513(f) (21 U.S.C. 360c(f)) is amended by adding at the end the following: "(3) If a manufacturer reports to the Secretary under section 510(k) that a device is substantially equivalent to another device— "(i) which the Secretary has classified as a class III device under subsection (b), "(ii) which was introduced or delivered for introduction into interstate commerce for commercial distribution before Decem- ber 1,1990, and "(iii) for which no final regulation requiring premarket ap- proval has been promulgated under section 5150b), the manufacturer shall certify to the Secretary that the manufac- turer has conducted a reasonable search of all information known or otherwise available to the manufacturer respecting such other device and has included in the report under section 510(k) a sum- mary of and a citation to all adverse safety and effectiveness data respecting such other device and respecting the device for which the 510(k) report is being made and which has not been submitted to the Secretary under section 519. The Secretary may require the manu- facturer to submit the adverse safety and effectiveness data de- scribed in the report.". (b) REVISION OF CLASSIFICATION.— (1) Section 515 (21 U.S.C. 360e) is amended by adding at the end the following:
"Revision
"(i)(l) Before December 1, 1995, the Secretary shall by order require manufacturers of devices, which were introduced or deliv- ered for introduction into interstate commerce for commercial dis-
PUBLIC LAW 101-629—NOV. 28, 1990 104 STAT. 4517
revising its classification, the Secretary shall publish a proposed regulation respecting the classification of a device under this subparagraph and provide an opportunity for the submission of comments on any such regulation. No regulation under this subparagraph requiring a device to remain in class III or revising its classification may take effect before the expiration of 90 days from the date of the publication in the Federal Register of the proposed regulation. "(C) The Secretary may by notice published in the Federal Reg- ister extend the period prescribed by subparagraph (B) for a device for an additional period not to exceed 1 year.". (3)(A) Notwithstanding section 520(1)(5) of the Federal Food, 21 use 360c Drug, and Cosmetic Act, the Secretary of Health and Human "°**' Services shall not retain any daily wear soft or daily wear nonhydrophilic plastic contact lens in class III under such Act unless the Secretary finds that it meets the criteria set forth in section 513(a)(lXC) of such Act. The finding and the grounds for Federal the finding shall be published in the Federal Register. For any Re^^r, such lens, the Secretary shall make the determination respect- ^" ing reclassification required in section 520(1)(5)(B) of such Act within 24 months of the date of the enactment of this paragraph. (B) The Secretary of Health and Human Services may by notice published in the Federal Register extend the two-year period prescribed by subparagraph (A) for a lens for an addi- tional period not to exceed one year. (C)(i) Before classifying a lens in class II pursuant to subpara- graph (A), the Secretary of Health and Human Services shall pursuant to section 513(a)(1)(B) of such Act assure that appro- priate regulatory safeguards are in effect which provide reason- able assurance of the safety and effectiveness of such lens, including clinical and preclinical data if deemed necessary by the Secretary. (ii) Prior to classifying a lens in class I pursuant to subpara- graph (A), the Secretary shall assure that appropriate regu- latory safeguards are in effect which provide reasonable assurance of the safety and effectiveness of such lens, including clinical and preclinical data if deemed necessary by the Secretary. (D) Notwithstanding section 520(1X5) of such Act, if the Sec- retary of Health and Human Services has not made the finding and published the finding required by subparagraph (A) within 36 months of the date of the enactment of this subparagraph, the Secretary shall issue an order placing the lens in class II. (E) Any person adversely affected by a final regulation under this paragraph revising the classification of a lens may chal- lenge the revision of the classification of such lens only by filing a petition under section 513(e) for a classification change.
SEC. 5. CLASSIFICATION AND RECLASSIFICATION OF DEVICES. (a) STANDARDS.— (1) Section 513(aXlXAXii) (21 U.S.C. 360c(aXlXAXii)) is amend- ed by striking out "or to establish a performance standard" and inserting in lieu thereof "or to establish special controls". (2) Section 513(aXlXB) (21 U.S.C. 360c(aXlXB)) is amended to read as follows:
104 STAT. 4518 PUBLIC LAW 101-629—NOV. 28, 1990
"(B) CLASS II, SPECIAL CONTROLS.—A device which cannot be clEissified as a class I device because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, develop- ment and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with section 510(k)), recommenda- tions, and other appropriate actions as the Secretary deems necessary to provide such assurance. For a device that is pur- ported or represented to be for a use in supporting or sustaining human life, the Secretary shall examine and identify the special controls, if any, that are necessary to provide adequate assur- ance of safety and effectiveness and describe how such controls provide such assurance.". (3) Clause (i) of section 513(a)(1)(C) (21 U.S.C. 360c(a)(l)(C)) is amended to read as follows: "(i) it (I) cannot be classified as a class I device because insufficient information exists to determine that the ap- plication of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, and (II) cannot be classified as a class II device because insufficient information exists to determine that the special controls described in subparagraph (B) would provide reasonable assurance of its safety and effectiveness, and". (b) CLASSIFICATION CHANGE.—Section 513(e) (21 U.S.C. 360c(e)) is amended by redesignating clauses (1) and (2) as clauses (A) and (B), respectively, and by inserting "(1)" after "(e)" and by adding at the end the following: "(2) By regulation promulgated under paragraph (1), the Secretary may change the classification of a device from class III— "(A) to class II if the Secretary determines that special con- trols would provide reasonable assurance of the safety and effectiveness of the device and that general controls would not provide reasonable assurance of the safety and effectiveness of the device, or "(B) to class I if the Secretary determines that general con- trols would provide reasonable assurance of the safety and effectiveness of the device.". (c) F.D.A. AUTHORITY TO INITIATE RECLASSIFICATION.— (1) Section 513(f)(2)(A) (21 U.S.C 360c(f)(2)(A)) is amended by striking out "The manufacturer" and inserting in lieu thereof "The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or ^ll6 IH£Lll.llf£LC^U.]T61* (2) Section 520(1)(2) (21 U.S.C. 360j(l)(2)) is amended by striking out "The manufacturer" and inserting in lieu thereof "The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer''. (3) The heading for section 513(f) (21 U.S.C. 360c(f)) is amended by inserting "and Reclassification" before "of.
104 STAT. 4520 PUBLIC LAW 101-629—NOV. 28, 1990
SEC. 7. REPORTS OF REMOVALS AND CORRECTIONS. Section 519 (21 U.S.C. 360i), as amended by sections 2 and 3, is amended by adding at the end the following:
"Reports of Removals and Corrections
"(fKD Except as provided in paragraph (2), the Secretary shall by regulation require a manufacturer, importer, or distributor of a device to report promptly to the Secretary any correction or removal of a device undertaken by such manufacturer, importer, or distribu- tor if the removal or correction was undertaken— "(A) to reduce a risk to health posed by the device, or "(B) to remedy a violation of this Act caused by the device which may present a risk to health. A manufacturer, importer, or distributor of a device who undertakes a correction or removal of a device which is not required to be reported under this paragraph shall keep a record of such correction or removal. "(2) No report of the corrective action or removal of a device may be required under paragraph (1) if a report of the corrective action or removal is required and has been submitted under subsection (a). "(3) For purposes of paragraphs (1) and (2), the terms 'correction' and 'removal' do not include routine servicing.".
SEC. 8. RECALL AUTHORITY. Section 518 (21 U.S.C. 360h).is amended by adding at the end the following new subsection:
"Recall Authority
"(eXD If the Secretary finds that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the device)— "(A) to immediately cease distribution of such device, and "(B) to immediately notify health professionals and device user facilities of the order and to instruct such professionals and facilities to cease use of such device. The order shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such device. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order. "(2)(A) If, after providing an opportunity for an informal hearing under paragraph (1), the Secretary determines that the order should be amended to include a recall of the device with respect to which the order was issued, the Secretary shall, except as provided in Reports. subparagraphs (B) and (C), amend the order to require a recall. The Secretary shall specify a timetable in which the device recall will occur and shall require periodic reports to the Secretary describing the progress of the recall. "(B) An amended order under subparagraph (A)— "(i) shall—
PUBLIC LAW 101-629—NOV. 28, 1990 104 STAT. 4521
"(I) not include recall of a device from individuals, and "(II) not include recall of a device from device user facili- ties if the Secretary determines that the risk of recalling such device from the facilities presents a greater health risk than the health risk of not recalling the device from use, and "(ii) shall provide for notice to individuals subject to the risks associated with the use of such device. In providing the notice required by clause (ii), the Secretary may use the assistance of health professionals who prescribed or used such a device for individuals. If a significant number of such individuals cannot be identified, the Secretary shall notify such individuals pursuant to section 705(b). "(3) The remedy provided by this subsection shall be in addition to remedies provided by subsections (a), (b), and (c).".
SEC. 9. TEMPORARY SUSPENSION OF APPROVAL OF APPLICATION.
(a) SUSPENSION.—Section 515(e) (21 U.S.C. 360e(e)) is amended— (1) by adding at the end the following: "(3) If, after providing an opportunity for an informal hearing, the Secretary determines there is reasonable probability that the continuation of distribution of a device under an approved applica- tion would cause serious, adverse health consequences or death, the Secretary shall by order temporarily suspend the approval of the application approved under this section. If the Secretary issues such an order, the Secretary shall proceed expeditiously under paragraph (1) to withdraw such application.", and (2) in the subsection heading, by inserting "and Temporary Suspension" after "Withdrawal". (b) CONFORMING AMENDMENT.—Section 501(f) (21 U.S.C. 351(f) is amended— (1) in s u b p a r ^ a p h (A)(iiXII), bv striking out "or withdrawn" and inserting in lieu thereof , suspended, or withdrawn", (2) in subparagraph (BXii), by striking out "which does not have such an application in effect" and inserting in lieu thereof "which has an application which has been suspended or is otherwise not in effect", and (3) in subparagraph (C), by striking out "which does not have such an application in effect" and inserting in lieu thereof "which has an application which has been suspended or is otherwise not in effect".
SEC. 10. POSTMARKET SURVEILLANCE.
Subchapter A of chapter 5 is amended by inserting after section 521 (21 U.S.C. 360k) the following new section:
"POSTMARKET SURVEILLANCE
"SEC. 522. (a) IN GENERAL.— 21 u s e 360/. "(1) REQUIRED SURVEILLANCE.—The Secretary shall require a manufacturer to conduct postmarket surveillance for any device of the manufacturer first introduced or delivered for introduc- tion into interstate commerce after January 1, 1991, that— "(A) is a permanent implant the failure of which may cause serious, adverse health consequences or death, "(B) is intended for a use in supporting or sustaining human life, or
PUBLIC LAW 101-629—NOV. 28, 1990 104 STAT. 4523
Effective date.
Federal Register, publication.
graph (IXA) shall be available for use by the Secretary as the evidentiary basis for the regulatory action described in subpara- graph (A).
"(DXi) This paragraph shall become effective— "(I) on November 15, 1990, for devices for which four devices of a kind were approved on or before December 31, 1987, and "(11) on November 15, 1991, for devices not described in subclause (I). "(ii) For each device described in clause (iXD, the Secretary shall publish a notice in the Federal Register setting forth the date, which shall be not earlier than 1 year after the date of the notice, that data identified in subparagraph (A) shall be available for the use of the Secretary.
"(EXi) Except £is provided in clause (ii), the approval date of a device, for purposes of this paragraph, shall be the date of the letter of the Secretary to the applicant approving a device under section 515 and permitting the applicant to commercially distribute the device. "(ii) For each device described in subparsigraph (DXDdD for which the original application for a fourth device of a kind is approved by the Secretary before November 1, 1991, the approval date of the fourth device of a kind shall be deemed to be November 15, 1991. "(F) Any challenge to an order under subparagraph (B) shall be made not later than 30 days after the date of the Federal Register notice referred to in such subparagraph.".
SEC. 12. SUBSTANTIAL EQUIVALENCE.
(a) SUBSTANTIAL EQUIVALENCE.—Section 513 (21 U.S.C. 360j) is 21 use 360c. amended by adding at the end the following new subsection:
"Substantial Equivalence
"(iXlXA) For purposes of determinations of substantial equiva- lence under subsection (f) and section 520(1), the term 'substantially equivalent' or 'substantial equivalence' means, with respect to a device being compared to a predicate device, that the device has the same intended use as the predicate device and that the Secretary by order has found that the device—
"(i) has the same technological characteristics as the predi- cate device, or "(iiXD has different technological characteristics and the information submitted that the device is substantially equiva- lent to the predicate device contains information, including clinical data if deemed necessary by the Secretory, that dem- onstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and efficacy than the predicate device. "(B) For purposes of subparagraph (A), the term 'different techno- logical characteristics' means, with respect to a device being com- pared to a predicate device, that there is a significant change in the materials, design, energy source, or other features of the device from those of the predicate device. "(2) A device may not be found to be substantially equivalent to a - predicate device that has been removed from the market at the initiative of the Secretary or that has been determined to be mis- branded or adulterated by a judicial order.
104 STAT. 4524 PUBLIC LAW 101-629—NOV. 28, 1990
"(3)(A) As part of a submission under section 510(k) respecting a device, the person required to file a premarket notification under such section shall provide an adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request by any person. Public "(B) Any summary under subparagraph (A) respecting a device information. shall Contain detailed information regarding data concerning ad- verse health effects and shall be made available to the public by the Secretary within 30 days of the issuance of a determination that such device is substantially equivalent to another device.". 21 use 360c 0>) REGULATIONS.—Within 12 months of the date of the enactment note. of this Act, the Secretary of Health and Human Services shall issue regulations establishing the requirements of the summaries under section 513(iX3) of the Federal Food, Drug, and Cosmetic Act, as added by the amendment made by subsection (a).
SEC. 13. JUDICIAL REVIEW.
Section 517(a) (21 U.S.C. 360g(a)) is amended— (1) by striking out "or" at the end of paragraph (6), and (2) by inserting after paragraph (7) the following new para- graphs: "(8) an order pursuant to section 513(i), "(9) a regulation under section 515(iX2) or 520(1X5XB), or "(10) an order under section 520(cX4XB),".
SEC. 14. HUMANITARIAN DEVICE EXEMPTION.
(a) EXEMPTION.—Section 520 (21 U.S.C. 360j) is amended by adding at the end the following:
"Humanitarian Device Exemption
"(mXl) To the extent consistent with the protection of the public health and safety and with ethical standards, it is the purpose of this subsection to encourage the discovery and use of devices in- tended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the United States. "(2) The Secretary may grant a request for an exemption from the effectiveness requirements of sections 514 and 515 for a device for which the Secretary finds that— "(A) the device is designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States, "(B) the device would not be available to a person with a disease or condition referred to in subparagraph (A) unless the Secretary grants such an exemption and there is no comparable device, other than under this exemption, available to treat or diagnose such disease or condition, and "(C) the device will not expose patients to an unreasonable or signihcant risk of illness or injury and the probable benefit to health from the use of the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. "(3) No person granted an exemption under paragraph (2) with respect to a device may sell the device for an amount that exceeds
104 STAT. 4526 PUBLIC LAW 101-629—NOV. 28, 1990
report on the activities of the Office of International Relations under section 803 of the Federal Food, Drug, and Cosmetic Act, added by subsection (a).
SEC. 16. REVIEW OF MARKET APPLICATIONS FOR ARTICLES COMPRISING COMBINATIONS OF DRUGS, DEVICES, AND BIOLOGICS.
(a) REVIEW.—Section 503 (21 U.S.C. 353) is amended— (1) by striking out the section heading and inserting in lieu thereof the following:
" E X E M P T I O N S AND CONSIDERATION FOR CERTAIN DRUGS, DEVICES, AND BIOLOGICAL P R O D U C T S " ,
and (2) by adding at the end the following: "(fKD The Secretary shall designate a component of the Food and Drug Administration to regulate products that constitute a combina- tion of a drug, device, or biological product. The Secretary shall determine the primary mode of action of the combination product. If the Secretary determines that the primary mode of action is that of— "(A) a drug (other than a biological product), the persons charged with premarket review of drugs shall have primary jurisdiction, "(B) a device, the persons charged with premarket review of devices shall have primary jurisdiction, or "(C) a biological product, the persons charged with premarket review of biological products shall have primary jurisdiction. "(2) Nothing in this subsection shall prevent the Secretary from using any agency resources of the Food and Drug Administration necessary to ensure adequate review of the safety, effectiveness, or substantial equivalence of an article. Regulations. "(3) The Secretary shall promulgate regulations to implement market approval procedures in accordance with paragraphs (1) and (2) not later than 1 year after the date of enactment of this sub- section. "(4) As used in this subsection: "(A) The term 'biological product' has the meaning given the term in section 351(a) of the Public Health Service Act ( U.S.C. 262(a)). "(B) The term 'market clearance' includes— "(i) approval of an application under section 505, 507, 515, or 520(g), "(ii) a finding of substantial equivalence under this sub- chapter, and "(iii) approval of a product or establishment license under subsection (a) or (d) of section 351 of the Public Health Service Act (42 U.S.C. 262).". flj) DEFINITIONS.—Section 201 (21 U.S.C. 321) is amended— (1) in paragraph (g)(1), by striking out "; but does not include devices or their componente, parts, or accessories", and (2) in paragraph (h)(3), by striking out "any of its principal" and inserting in lieu thereof "its primary".
SEC. 17. CIVIL PENALTIES. (a) AMENDMENT.—Section 303 (21 U.S.C. 333) is amended by adding at the end the following:
PUBLIC LAW 101-629—NOV. 28, 1990 104 STAT. 4527
"(fKlXA) Except as provided in subparagraph (B), any person who violates a requirement of this Act which relates to devices shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such violation, and not to exceed $1,000, for all such violations adjudicated in a single proceeding. "(B) SubparEigraph (A) shall not apply— "(i) to any person who violates the requirements of section 519(a) or 520(f) unless such violation constitutes (I) a significant or knowing departure from such requirements, or (II) a risk to public health, "(ii) to any person who commits minor violations of section 519(e) or 519(f) (only with respect to correction reports) if such person demonstrates substantial compliance with such section, or "(iii) to violations of section 501(aX2)(A) which involve one or more devices which are not defective. "(2)(A) A civil penalty under paragraph (1) shall be assessed by the Secretary by an order made on the record after opportunity for a hearing provided in accordance with this subparagraph and section 554 of title 5, United States Code. Before issuing such an order, the Secretary shall give written notice to the person to be assessed a civil penalty under such order of the Secretary's proposal to issue such order and provide such person an opportunity for a hearing on the order. In the course of any investigation, the Secretary may issue subpoenas requiring the attendance and testimony of wit- nesses and the production of evidence that relates to the matter under investigation.
"(B) In determining the amount of a civil penalty, the Secretary shall take into account the nature, circumstances, extent, and grav- ity of the violation or violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require. "(C) The Secretary may compromise, modify, or remit, with or without conditions, any civil penalty which may be assessed under paragraph (1). The amount of such penalty, when finally deter- mined, or the amount agreed upon in compromise, may be deducted from any sums owing by the United States to the person charged. "(3) Any person who requested, in accordance with paragraph (2)(A), a hearing respecting the assessment of a civil penalty and who is aggrieved by an order assessing a civil penalty may file a petition for judicial review of such order with the United States CJourt of Appeals for the District of Columbia Circuit or for any other circuit in which such person resides or transacts business. Such a petition may only be filed within the 60-day period beginning on the date the order making such assessment was issued. "(4) If any person fails to pay an assessment of a civil penalty— "(A) after the order making the assessment becomes final, and if such person does not file a petition for judicial review of the order in accordance with paragraph (3), or "(B) after a court in an action brought under paragraph (3) has entered a final judgment in favor of the Secretary, the Attorney General shall recover the amount assessed (plus in- terest at currently prevailing rates from the date of the expiration of the 60-day period referred to in paragraph (3) or the date of such final judgment, as the case may be) in an action brought in any appropriate district court of the United States. In such an action,
PUBLIC LAW 101-629—NOV. 28, 1990 104 STAT. 4529
(d) SECTION 516.—Section 516(a) (21 U.S.C. 360f(a)) is amended (1) by striking out "and after consultation with the appropriate panel or panels under section 513", and (2) by striking out the last ' sentence (e) SECTION 520(f).—Section 520(f)(lXA) (21 U.S.C. 360j(f)(l)(A)) is amended by inserting "pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device)," after "manufacture,". (f) SECTION 520(1).—Section 520(1X2) (21 U.S.C. 360j(lX2)) is amended by striking out "and after affording the petitioner an opportunity for an informal hearing".
SEC. 19. ELECTRONIC PRODUCTS.
(a) I N GENERAL.— (1) Subpart 3 of part F of title III of the Public Health Service Act is amended as follows: 42 USC prec. (A) The heading for the subpart is amended to read as ^^^''• follows:
"SUBCHAPTER C—ELECTRONIC PRODUCT RADIATION CONTROL".
(B) The subpart is amended by striking out "subpart" ^L^J^q each place it occurs and inserting in lieu thereof "sub- 263b-263n, chapter". (2XA) Section 356 of such Act is amended— 42 use 263d. (i) by striking out "358" each place it occurs and inserting in lieu thereof "534", and (ii) by striking out "sections 3648 and 3709 of the Revised Statutes of the United States (31 U.S.C. 529, 41 U.S.C. 5)" and inserting in lieu thereof "section 3324 of title 31, United States Code, and section 3709 of the Revised Stat- utes of the United States (41 U.S.C. 5)". (B) Section 358(aXlXE) of such Act is amended by striking out 42 USC 263f. "355" and inserting in lieu thereof "531". (C) Section 359 of such Act is amended— 42 USC 263g. (i) by striking out "358" each place it occurs and inserting in lieu thereof "534", and (ii) by striking out "360A" each place it occurs and insert- ing in lieu thereof "537". (D) Section 360 of such Act is amended by striking out "358" 42 USC 263h. each place it occurs and inserting in lieu thereof "534". (E) Section 360A of such Act is amended— 42 USC 263i. (i) by striking out "358" and inserting in lieu thereof "534", and (ii) by striking out "359" each place it occurs and insert- ing in lieu thereof "535". (F) Section 360B of such Act is amended— 42 USC 263j. (i) by striking out "358" each place it occurs and inserting in lieu thereof "534", (ii) by striking out "359" each place it occurs and insert- ing in lieu thereof "535", and (iii) by striking out "360A" each place it occurs and inserting in lieu thereof "537". (G) Section 360C of such Act is amended— 42 USC 263k.
104 STAT. 4530 PUBLIC LAW^ 101-629— NOV.^ 28, 1990
42 u s e 263n.
Repeal. 42 u s e 263b. 42 u s e 263c- 263n.
42 use 263b-263n.
21 use 360gg-3608s.
42 u s e prec. 262.
21 u s e 360hh.
(i) by striking out "358" and inserting in lieu thereof "534", (ii) by striking out "360B" each place it occurs and insert- ing in lieu thereof "538", and (iii) by striking out "360F" and inserting in lieu thereof "542". (H) Section 360F of such Act is amended by striking out "358" and inserting in lieu thereof "534". (3) Section 354 of such Act is repealed and sections 355 through 360F of such Act are redesignated as sections 531 through 542, respectively. (4) Subpart 3 of part F of title III of the Public Health Service Act, as amended by paragraphs (1) and (2) of this subsection, is transferred to chapter V of the Federal Food, Drug, and Cos- metic Act and is placed after section 528 and sections 354 through 360F of such subpart are redesignated as sections 530 through 542 of the Federal Food, Drug, and Cosmetic Act, respectively. (b) CONFORMING AMENDMENT.—The heading for part F of title III of the Public Health Service Act is amended by striking out "AND CONTROL OF RADIATION". (c) CONSTRUCTION.—The transfer of subpart 3 of part F of title III of the Public Health Service Act to the Federal Food, Drug, and Cosmetic Act does not change the application of the requirements of such subpart and such Act to electronic products which were in effect on the date of the enactment of this Act.
Approved November 28, 1990.
LEGISLATIVE HISTORY—H.R. 3095 (S. 3006): HOUSE REPORTS: No. 101-808 (eomm. on Energy and eommerce) and No. 101- (eomm. of eonference). SENATE REPORTS: No. 101-513 accompanying S. 3006 (Coram, on Labor and Huraan Resources). C O N G R E S S I O N A L R E C O R D , Vol. 136 (1990): Oct. 10, considered and passed House. Oct. 12, H.R. 3095 considered and passed Senate, amended, in lieu of S. 3006. Oct. 26, House agreed to conference report. Oct. 27, Senate agreed to conference report.
