[Federal Register Volume 63, Number 142 (Friday, July 24, 1998)]
[Proposed Rules]
[Pages 39789-39790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19916]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 808

[Docket No. 97N-0222]


Medical Devices; Preemption of State Product Liability Claims

AGENCY: Food and Drug Administration, HHS.

ACTION: Withdrawal of proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
is withdrawing a proposed rule that published in the Federal Register 
of December 12, 1997 (62 FR 65384), relating to medical device 
preemption of State product liability claims. FDA is making this 
withdrawal because of concerns that have been raised regarding the 
interplay between the FDA Modernization Act of 1997 (FDAMA) and the 
proposed rule.

DATES: The proposed rule is withdrawn July 24, 1998.

ADDRESSES: Copies of the draft proposed rule and its comments may be 
obtained from the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-827-2974.

SUPPLEMENTARY INFORMATION: Section 521 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360k) contains an express preemption 
provision applicable to medical devices regulated by FDA. The Supreme 
Court addressed whether section 521 of the act preempts State common 
law tort claims arising from allegedly defective medical devices. (See 
Medtronic, Inc. v. Lohr (Lohr), 116 S.Ct. 2240 (1996).) The Court 
concluded that section 521 of the act did not supplant the State law 
duties for devices marketed pursuant to a premarket clearance issued 
under section 510(k) of the act (21 U.S.C. 360(k)). Since Lohr was 
decided, the lower courts have interpreted section 521 of the act 
inconsistently and have reached conflicting conclusions with respect to 
whether section 521 of the act preempts State law claims for injuries 
allegedly resulting from medical devices that have received premarket 
approval under section 515 of the act (21 U.S.C. 360e), or have 
received an investigational device exemption under section 520(g) of 
the act (21 U.S.C. 360j(g)).
    In light of the confusion among the lower courts in interpreting 
section 521 of the act since Lohr, and in accordance with the Supreme 
Court's recognition that FDA's interpretation of the preemptive effect 
of section 521 of the act is entitled to substantial weight, the agency 
issued the proposed rule in the Federal Register of December 12, 1997 
(62 FR 65384), addressing the circumstances under which section 521 of 
the act preempts State common law tort claims based on injury from 
allegedly defective medical devices. The proposal is consistent with 
the position that the agency has historically taken on issues related 
to device preemption. The comment period on this proposed rule was open 
until February 10, 1998. The agency received 41 comments from a variety 
of associations, law firms, and individuals representing industry and 
consumer interests.
    FDA has decided to withdraw the rulemaking to amend its regulations 
regarding preemption of State and local requirements applicable to 
medical devices. FDA is taking this action because, even though the 
proposed rule was issued after the enactment of FDAMA, it was 
conceptualized and written prior to enactment.
    Concerns have been raised by industry and congressional 
representatives that the agency did not share its thinking on its 
interpretation of section 521 of the act during FDAMA deliberations, 
even though an early draft of the proposed rule was shared during the 
spring of 1997 with attorneys for Public Citizen Litigation Group, who 
represented Lohr in the Lohr case. The remedy under FDA's regulations 
for disclosure of a draft regulation is ordinarily to issue a notice in 
the Federal Register making the draft publicly available. See 21 CFR 
10.80(b)(2). Such a contemporaneous notice was not, however, provided 
in this case.
    Because of the great policy significance of these preemption 
issues, the concern that Congress was not aware of the agency's 
thinking during FDAMA deliberations, and the potential interplay 
between the FDAMA device provisions and device preemption, the agency 
believes that it is imperative for all interested parties to have 
confidence that the agency is addressing their concerns in an impartial 
manner. Therefore, the agency is taking the unusual step of withdrawing 
the proposed rule.
    The early draft of the proposed rule that was disclosed, the 
comments on it, and the correspondence raising

[[Page 39790]]

concerns about the disclosure are being placed in the Dockets 
Management Branch (address above) and can be identified with the docket 
number found in brackets in the heading of the document.

    Dated: July 17, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-19916 Filed 7-21-98; 5:07 pm]
BILLING CODE 4160-01-F