Page images
PDF
EPUB

NOV. 28,

, "(B) CLASS II, SPECIAL CONTROLS.—A device which cannot be classified 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, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with section 510(k)), recommendations, and other appropriate actions as the Secretary deems necessary to provide such assurance. For a device that is purported 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 assurance 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)(1)(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 application 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 controls 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 controls 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 the manufacturer”.

(2) Section 520(1/2) (21 U.S.C. 360j(1)(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".

SEC. 6. ESTABLISHMENT OF PERFORMANCE STANDARDS.
(a) PROCEDURE.-Section 514 (21 U.S.C. 360d) is amended-

(1) in subsection (a), by amending the first sentence to read as follows: "The special controls required by section 513(a)(1)(B) shall include performance standards for a class II device if the Secretary determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device.",

(2) by striking out subsections (b) through (f),
(3) by redesignating subsection (g) as subsection (b),

(4) in subsection (b) (as redesignated), by amending paragraphs (1) and (2) to read as follows: “(1)(A) The Secretary shall publish in the Federal Register a Federal notice of proposed rulemaking for the establishment, amendment, or

Register,

publication. revocation of any performance standard for a device.

"(B) A notice of proposed rulemaking for the establishment or amendment of a performance standard for a device shall

“(i) set forth a finding with supporting justification that the performance standard is appropriate and necessary to provide reasonable assurance of the safety and effectiveness of the device,

"(ii) set forth proposed findings with respect to the risk of illness or injury that the performance standard is intended to reduce or eliminate,

"(iii) invite interested persons to submit to the Secretary, within 30 days of the publication of the notice, requests for changes in the classification of the device pursuant to section 513(e) based on new information relevant to the classification, and

"(iv) invite interested persons to submit an existing performance standard for the device, including a draft or proposed

performance standard, for consideration by the Secretary. "(C) A notice of proposed rulemaking for the revocation of a performance standard shall set forth a finding with supporting justification that the performance standard is no longer necessary to provide reasonable assurance of the safety and effectiveness of a device.

"(D) The Secretary shall provide for a comment period of not less than 60 days.

“(2) If, after publication of a notice in accordance with paragraph (1), the Secretary receives a request for a change in the classification of the device, the Secretary shall, within 60 days of the publication of the notice, after consultation with the appropriate panel under section 513, either deny the request or give notice of an intent to initiate such change under section 513(e).”. (b) CONFORMING AMENDMENTS.

(1) Section 514(b) (as redesignated by subsection (a)(3)) is amended

(A) in paragraph (3)(A), by striking out “paragraph (2)” and inserting in lieu thereof paragraph (1)", and

(B) in paragraph (4)(A), by striking out "paragraphs (2) and (3)(B)” and inserting in lieu thereof "paragraphs (1), (2),

and (3)(B)". (2) Section 520(i) (21 U.S.C. 360j(i)) is amended by striking out “514(g)(5)(B)” and inserting in lieu thereof “514(b)(5)(B)”.

66

39-194 0 - 91 - 5:QL 3 Part 6

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

“(f)(1) 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 distributor 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 "(e)(1) 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 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) Ăn amended order under subparagraph (A)—

"(i) shall

Reports.

"(I) not include recall of a device from individuals, and

"(II) not include recall of a device from device user facilities 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 application 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 subparagraph (A)(ii)(II), by striking out “or withdrawn” and inserting in lieu thereof “, suspended, or withdrawn”,

(2) in subparagraph (B)(ii), 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:

[ocr errors]

"POSTMARKET SURVEILLANCE

21 USC 3601.

"SEC. 522. (a) IN GENERAL.

“(1) REQUIRED SURVEILLANCE.—The Secretary shall require a manufacturer to conduct postmarket surveillance for any device of the manufacturer first introduced or delivered for introduction 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

"(C) potentially presents a serious risk to human health. "(2) DISCRETIONARY SURVEILLANCE. — The Secretary may require a manufacturer to conduct postmarket surveillance for a device of the manufacturer if the Secretary determines that postmarket surveillance of the device is necessary to protect the public health or to provide safety or effectiveness data for the

device. "(b) SURVEILLANCE APPROVAL.- Each manufacturer required to conduct a surveillance of a device under subsection (a) shall, within 30 days of the first introduction or delivery for introduction of such device into interstate commerce submit, for the approval of the Secretary, a protocol for the required surveillance. The Secretary, within 60 days of the receipt of such protocol, shall determine if the principal investigator proposed to be used in the surveillance has sufficient qualifications and experience to conduct such surveillance and if such protocol will result in collection of useful data or other information necessary to protect the public health and to provide safety and effectiveness information for the device. The Secretary may not approve such a protocol until it has been reviewed by an appropriately qualified scientific and technical review committee established by the Secretary.". SEC. 11. USE OF PREMARKET APPROVAL DATA. Section 520 (21 U.S.C. 360j) is amended(1) in subsection (c)

(A) by striking out "under section 513 from class III to class II" and inserting in lieu thereof "from class III to class II or class I”, and

(B) by inserting "(1) in accordance with subsection (h), and (2)' after "except", and (2) in subsection (h)—

(A) in paragraph (3), by striking out “Any” and inserting in lieu thereof "Except as provided in paragraph (4), any”, and

(B) by adding at the end the following new paragraph: "(4)(A) Any information contained in an application for premarket approval filed with the Secretary pursuant to section 515(c), including clinical and preclinical tests or studies, but excluding descriptions of methods of manufacture and product composition, that demonstrates the safety and effectiveness of a device shall be available 1 year after the original application for the fourth device of a kind has been approved by the Secretary, for use by the Secretary in approving devices, or determining whether a product development protocol has been completed, under section 515, establishing a performance standard under section 514, and reclassifying devices under subsections (e) and (f) of section 513, and subsection 12). The Secretary shall deem devices that incorporate the same technologies, have the same principles of operation, and are intended for

the same use or uses to be within a kind of device. Federal

"(B) The Secretary, contemporaneously with the approval of the Register publication.

fourth device of a kind, shall publish an order in the Federal Register identifying the four devices of a kind that have been approved under section 515 and the date on which the data contained in premarket approval applications for the devices will be available to the Secretary for use, as described in subparagraph (A).

(C) The publicly available detailed summaries of information respecting the safety and effectiveness of devices required by para

« PreviousContinue »