[Federal Register Volume 62, Number 239 (Friday, December 12, 1997)]
[Proposed Rules]
[Pages 65384-65388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32551]


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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulations regarding preemption of State and local requirements 
applicable to medical devices. This action is being taken to clarify 
and codify the agency's longstanding position that available legal 
remedies, including State common law tort claims, generally are not 
preempted under the Federal Food, Drug, and Cosmetic Act (the act).

DATES: Written comments by February 10, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

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:

I. Introduction

    Section 521 of the act (21 U.S.C. 360k) contains an express 
preemption provision applicable to medical devices regulated by FDA. 
The Supreme Court recently 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 at issue in that case. In reaching that 
conclusion, the Court noted that FDA has provided interpretive guidance 
with respect to section 521 of the act's preemptive effect. (See id. at 
2255-2256 (citing 21 CFR 808.1(d)(2) and 808.5(b)(1)(i) (1995)).) The 
Court gave ``substantial weight to the agency's view of the statute'' 
(Id. at 2256). (See also id. at 2257; id. at 2260-2261 (Breyer, J., 
concurring in part and concurring in the judgment).)
    The Court's decision in Lohr construed section 521 of the act in 
the context of a medical device that FDA had cleared for distribution 
under section 510(k) of the act (21 U.S.C. 360k), which requires 
premarket notification for certain types of medical devices. The Court 
did not definitively decide whether section 521 of the act may preempt 
State law claims in other circumstances. 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 (IDE) 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 is entitled to substantial weight, the agency is issuing 
this proposed interpretive rule, which addresses the circumstances in 
which section 521 of the act preempts State common tort claims based on 
injury from allegedly defective medical devices.

II. Background

    Congress enacted the Medical Device Amendments of 1976 (the 
amendments) (21 U.S.C. 360c et seq.), ``to provide for the safety and 
effectiveness of medical devices intended for human use.'' It

[[Page 65385]]

enacted the amendments largely in response to public concerns over 
injuries caused by medical products, such as the Dalkon Shield 
intrauterine device. (See S. Rept. No. 33, 94th Cong., 1st sess. 1 
(1975); H. R. Rept. No. 853, 94th Cong., 2d sess. 8 (1976); 122 
Congressional Record 13,779 (1976)). Congress sought ``to assure that 
the public is protected from unsafe and ineffective medical devices, 
that health professionals have more confidence in the devices they use 
or prescribe, and that innovations in medical device technology are not 
stifled by unnecessary restrictions'' (H. R. Rept. No. 853, supra, at 
12).
    Section 521 of the act was included as part of the amendments, and 
generally states that except as provided in section 521(b) of the act 
no State or political subdivision of a State may establish or continue 
in effect with respect to a device intended for human use any 
requirement which is different from, or in addition to, any Federal 
requirement applicable to the device, and which relates to the safety 
or effectiveness of the device or to any other matter included in a 
Federal requirement applicable to the device.
    Section 521(b) sets forth the requirements if a political 
subdivision thereof applies for an exemption from a Federal 
requirement. The Secretary may issue a regulation to exempt from 
section 521(a) of the act, under conditions prescribed in the 
regulation, if the requirement is more stringent than the Federal 
requirement which would be applicable to the device if an exemption 
were not in effect or the requirement is required by compelling local 
conditions, and compliance with the requirement would not cause the 
device to be in violation of any applicable Federal requirement under 
this chapter.
    FDA has interpreted the preemptive scope of section 521 of the act 
in light of its specific language and Congress's expressed objectives. 
Section 521(a) forbids a State from subjecting a medical device to any 
``requirement'' that is ``different from, or in addition to,'' any 
Federal requirement imposed under the act; and relates to ``the safety 
or effectiveness of the device'' or to ``any other matter'' included in 
the Federal requirement. FDA has indicated, through regulations that 
have been in place since 1978, that section 521 of the act's preemptive 
effect is limited in light of the section's precise terminology and 
Congress's declared intention to promote the safety and effectiveness 
of medical devices. (See 21 CFR 808.1.)
    When FDA issued its 1978 regulations, the regulated community was 
primarily interested in the effect of section 521 of the act on State 
or local requirements that were expressed through positive enactments, 
such as statutes or regulations. FDA's regulations addressed the 
question of preemption in that general context. Section 808.1(d), which 
has remained substantially unchanged for nearly 20 years, states that 
State or local requirements are preempted only when FDA has established 
specific counterpart regulations or there are other specific 
requirements applicable to a particular device under the act, thereby 
making any existing divergent State or local requirements applicable to 
the device different from, or in addition to, the specific FDA 
requirements. There are other State or local requirements that affect 
devices that are not preempted by section 521(a) of the act because 
they are not ``requirements applicable to a device'' within the meaning 
of section 521(a) of the act.
    FDA's regulations (Sec. 808.1) provide nine examples of State or 
local provisions that are not preempted, including:
    (1) Generally applicable requirements not limited to medical 
devices (e.g., general electrical codes and the Uniform Commercial Code 
(warranty of fitness));
    (2) Requirements that are equal to or substantially identical to 
requirements imposed by or under the act;
    (3) Occupational licensing requirements;
    (4) Specifications in government contracts for the procurement of 
devices;
    (5) Criteria for payment of State or local obligations under 
Medicaid and similar Federal, State or local health care programs;
    (6) General enforcement requirements, including State inspection 
and registration requirements, or a State or local prohibition against 
the manufacturer of adulterated or misbranded devices (except where the 
prohibition, as interpreted and enforced, has the effect of 
establishing a substantive requirement for a specific device);
    (7) Provisions respecting delegations of authority and related 
administrative matters respecting devices;
    (8) Fee and other revenue raising requirements; and
    (9) State or local requirements issued under the authority of other 
Federal statutes.
    In 1992, the Supreme Court decided Cippolone v. Liggett Group, Inc. 
(505 U.S. 504 (1992)). Among other things, the Court ruled in that case 
that section 5(b) of the Public Health Cigarette Smoking Act of 1969 
(15 U.S.C. 1334(b)) could preempt State common law suits alleging that 
the manufacturers breached their duty to warn about hazards associated 
with smoking. Section 5(b) states that no requirement or prohibition 
based on smoking and health shall be imposed under State law with 
respect to the advertising or promotion of any cigarettes the packages 
of which are labeled in conformity with the provisions of this chapter.
    A majority of the Supreme Court concluded that the phrase ``[n]o 
requirement or prohibition,'' as used in that statute, describes both 
positive enactments and common law duties. (See 505 U.S. at 521 
(opinion of Stevens, J.); id. at 548-549 (Scalia, J., concurring in the 
judgment in part and dissenting in part).)
    After the Supreme Court's decision in Cippolone, a number of lower 
courts interpreted section 521 of the act to preempt tort actions 
respecting allegedly defective medical devices in which the plaintiff 
sought to hold the manufacturer liable based on State common law. Those 
courts found preemption in a variety of contexts, including situations 
in which FDA had allowed marketing of the device after ``premarket 
notification'' under section 510(k) of the act (21 U.S.C. 360(k)), 
(e.g., Mendes v. Medtronic, Inc., 18 F.3d 13 (1st Cir. 1994)); in which 
FDA had granted premarket approval of the device under section 515 of 
the act (21 U.S.C. 360e), (e.g., King v. Collagen Corp., 983 F.2d 1130 
(1st Cir.) cert. denied, 510 U.S. 824 (1993)); and in which FDA had 
granted an IDE under section 520(g) of the act (21 U.S.C. 360j(g)), 
(e.g., Slater v. Optical Radiation Corp., 961 F.2d 1330 (7th Cir.), 
cert. denied, 506 U.S. 917 (1992)).
    The Supreme Court addressed the scope of section 521 of the act's 
preemptive effect in Medtronic, Inc. v. Lohr, 116 S. Ct. 2240 (1996). 
That case arose out of Medtronic's marketing of a cardiac pacemaker 
that FDA found was ``substantially equivalent'' to a medical device 
already on the market and that was therefore subject to the premarket 
notification requirements of section 510(k) of the act (21 U.S.C. 
360(k)). The plaintiffs alleged that they were injured by the device 
and sought damages under Florida common law. They asserted that 
Medtronic breached its common law duty ``to use reasonable care in the 
design, manufacture, assembly, and sale of the subject pacemaker'' and 
that Medtronic was strictly liable because the device ``was in a 
defective condition and unreasonably dangerous to foreseeable users at 
the time of its sale'' (116 S. Ct. at 2248).

[[Page 65386]]

    The Court concluded that section 521 of the act did not preempt the 
plaintiffs' negligent design claim. It specifically rejected 
Medtronic's contention that the company's compliance with its statutory 
obligation to demonstrate through the premarket notification process 
that the pacemaker was ``substantially equivalent'' to a preexisting 
device preempted those claims (116 S. Ct. at 2254-2255). The Court 
noted that, when FDA reviews a device under the premarket notification 
provisions, it does so with ``a concern for the safety and 
effectiveness of the device'' (id. at 2254), but that FDA ``did not 
'require' Medtronics' pacemaker to take any particular form for any 
particular reason'' (ibid). Rather, FDA simply allowed Medtronic to 
market the pacemaker based on the article's equivalence to the 
preexisting device (Id. at 2254-2255). The Supreme Court was unanimous 
on this point, since Justice O'Connor's separate opinion for four 
Justices agreed that the section 510(k) premarket notification process 
``places no `requirement' on a device'' and therefore does not preempt 
a defective design claim (Id. at 2264).
    The Court also concluded that section 521 of the act did not 
preempt the plaintiffs' State law claims that Medtronic had violated 
FDA requirements (116 S. Ct. at 2255-2256). The Court reasoned that 
State common law claims premised on Medtronic's failure to comply with 
FDA requirements do not subject the manufacturer to requirements that 
are ``different from, or in addition to,'' the Federal requirements 
(Id. at 2255). The Court noted that FDA's interpretive regulations 
``expressly support the conclusion that [section 521] `does not preempt 
State or local requirements that are equal to, or substantially 
identical to, requirements imposed by or under the act.''' (Id. at 2256 
(quoting 21 CFR 808.1(d)(2) (1995))). It also observed that FDA's views 
on the scope of section 521 of the act's preemptive effect are entitled 
to ``substantial weight.'' (Ibid).
    The Court additionally concluded that section 521 of the act did 
not preempt the plaintiffs' State law claims based on negligent 
manufacturing and labeling (116 S. Ct. at 2256-2258). The Court 
recognized that FDA had developed regulations that set out general 
``requirements'' for manufacturing and labeling medical devices (Id. at 
2256). It concluded, however, that section 521 generally does not 
mandate preemption of a standard of care under State common law unless, 
as FDA had suggested in its interpretive regulations, FDA has issued 
``specific counterpart regulations or * * * other specific requirements 
applicable to a particular device'' (Id. at 2257 (quoting 21 CFR 
808.1(d) (1995))). The Court concluded that the ``entirely generic'' 
Federal requirements did not provide a basis for preemption of the 
nonspecific State common law duties at issue in that case (Id. at 
2258). Justice Breyer, agreeing with Justice O'Connor's opinion (see 
id. at 2262-2263), concluded that, insofar as the act preempts a State 
requirement embodied in a statute or regulation, it also preempts a 
similar State requirement that takes the form of a standard of care 
imposed by State tort law (id. at 2259-2260), but he concurred in the 
Court's holding that manufacturing and labeling requirements issued by 
FDA were not sufficiently specific to trigger preemption (id. at 2260-
2261).
    Since the Supreme Court's decision in Lohr, the lower courts have 
continued to reach contradictory determinations respecting section 521 
of the act's preemptive effect, particularly as it relates to medical 
devices that have received premarket approval or an investigatory 
device exemption. Compare, e.g., Fry v. Allergan Medical Optics, 695 
A.2d 511 (R.I. 1997) (finding preemption), cert. denied, No. 97-513 
(U.S. Sup. Ct., Nov. 3, 1997) with Kernats v. Smiths Indus. Med. Sys., 
Inc., 669 N.E. 2d 1300 (Ill. App. Ct.) (finding no preemption), appeal 
denied, 675 N.E.2d (Ill. 1996), petition for cert. pending, No. 96-1405 
(U.S. Sup. Ct., filed Mar. 4. 1997).

III. The Proposed Rule

    FDA interprets section 521 of the act's preemptive effect on the 
basis of congressional intent. As the Supreme Court stated in Lohr, 
congressional purpose ``is the ultimate touchstone'' in every 
preemption case, and ``a fair understanding of congressional purpose'' 
may be discerned not only from the text of the statute, but also 
through a ``reasoned understanding of the way in which Congress 
intended the statute and its surrounding regulatory scheme to affect 
business, consumers, and the law'' (116 S. Ct. at 2250-2251 (emphasis 
deleted)). In addition, the statutory text must be read in light of 
established presumptions respecting preemption. As the Supreme Court 
stated in Lohr, the States are presumed to retain their historic police 
powers unless Congress expresses a ``clear and manifest purpose'' to 
supersede those powers (Id. at 2250).
    Section 521 of the act does not, as a general matter, prevent a 
party who is injured by a defective medical device from seeking redress 
under a State's common law. Rather, section 521(a) of the act provides 
that a State may not ``establish or continue in effect with respect to 
a device'' a ``requirement'' that is ``different from, or in addition 
to,'' a ``requirement applicable under this chapter to the device'' 
that ``relates to the safety or effectiveness of the device'' or to 
``any other matter included in'' the Federal requirement (21 U.S.C. 
360k(a)). By its plain terms, section 521 of the act does not prevent a 
State from imposing common law duties on manufacturers of medical 
devices unless those duties are ``requirements'' of the kind described 
in the statute.
    When FDA articulated its understanding of section 521 of the act in 
its 1978 regulations, it stated the general rule to be that ``State or 
local requirements are preempted only when the agency has established 
specific counterpart regulations or there are other specific 
requirements applicable to a particular device under the act, thereby 
making any existing divergent State or local requirements applicable to 
the device different from, or in addition to, the specific Food and 
Drug Administration requirements'' (Sec. 808.1(d)). The Supreme Court 
explicitly endorsed FDA's position in the Lohr decision. (See 116 S. 
Ct. at 2257; id. at 2260-2261 (Breyer, J., concurring in part and 
concurring in the judgment)). Similarly, the 1978 regulations provide 
that section 521 of the act does not preempt a State or local 
requirement prohibiting the manufacture of adulterated or misbranded 
devices, but that where such a prohibition, as ``interpreted and 
enforced by the State and local government,'' ``has the effect of 
establishing a substantive requirement for a specific device, e.g., a 
specific labeling requirement,'' it will be preempted if it is 
different from, or in addition to, a specific requirement established 
by FDA for the device (Sec. 808.1(d)(6)(ii)).
    In 1978, FDA stated its understanding of section 521 of the act in 
the general context of State requirements that are imposed through 
positive law, such as statutes or regulations. The same principles 
should govern, however, in the case of State requirements that are 
imposed through the common law. FDA has consistently concluded that the 
same principles govern when it has addressed the question of preemption 
through its regulations, advisory opinions, and its judicial filings as 
amicus curiae. The Supreme Court implicitly endorsed that conclusion in 
the Lohr decision by applying the principles that FDA has announced in 
its 1978 regulations to the Lohrs'

[[Page 65387]]

common law suit. (See 116 S. Ct. at 2255-2256, 2257-2258; id. at 2260-
2261 (Breyer, J., concurring in part and concurring in the judgment in 
part)).
    In accordance with the principles that FDA articulated in its 1978 
regulations, to which the Supreme Court in Lohr held that deference is 
owed, FDA believes that, as a general matter, an FDA-imposed 
requirement will preempt a State common law duty only when: (1) FDA has 
expressly imposed, by regulation or order, a specific substantive 
requirement applicable to a particular medical device; and (2) the 
State common law, as interpreted and applied, imposes a substantive 
requirement applicable to the same particular medical device that is 
different from, or in addition to, FDA's counterpart requirement. Under 
this approach, FDA requirements that are applicable to devices in 
general, or that are established by means other than through regulation 
or order, should generally not result in preemption of State tort 
claims.
    FDA bases its interpretation primarily on the language of section 
521 of the act and the agency's past regulatory interpretation set out 
in Sec. 808.1. In addition, a plurality of the Court noted in Lohr that 
there is no indication in the legislative history of the amendments 
that Congress intended to make a ``dramatic change'' in the 
availability of State common law remedies (Id. at 2253 n.13 (opinion of 
Stevens, J.)). The legislative history indicates that Congress was 
aware of ongoing product liability suits involving medical devices, but 
it contains no indication that Congress intended that the amendments 
would preempt those suits. See, e.g., S. Rept. No. 33, supra, at 1; H. 
R. Rept. No. 853, supra, at 8; 121 Congressional Record 10,688 (1975) 
(Sen. Kennedy); id. at 10,689 (Sen. Nelson); 122 Congressional Record 
5850 (1976) (Rep. Abzug)).
    FDA's interpretation is also founded in its experience and 
understanding gained through implementing the amendments. FDA believes 
that its general regulatory review and approval processes provide a 
significant measure of protection against the marketing of dangerous or 
defective medical devices. FDA does not believe, however, that those 
processes can guarantee the safety of such devices. Accordingly, 
compliance with general FDA requirements should not broadly preempt 
State common law remedies, which provide an important (and frequently 
the only) mechanism for persons to seek redress for injuries resulting 
from defective medical devices. FDA notes below several situations in 
which the agency's regulatory activities will typically not preempt 
State law remedies.
    First, FDA's general clearance and approval processes, such as the 
clearance for marketing under section 510(k) of the act; the grant 
premarket approval under section 515 of the act; or the grant of an IDE 
under section 520(g) of the act, do not, by themselves, preempt State 
common law claims. Section 521 of the act provides for preemption of a 
State common law duty only if it imposes a requirement that is 
different from, or in addition to, a specific substantive requirement 
pertaining to the particular device that has been imposed by or under 
the act. FDA's action in clearing a product for marketing or granting 
an application for a PMA or an IDE signifies that the manufacturer's 
proposal for marketing or use of the device in question satisfies the 
relevant statutory and regulatory criteria for the clearance, approval, 
or exemption. It does not signify, however, that Congress or FDA has 
established a specific Federal requirement (e.g., with respect to the 
design of the device) that supplants a State common law duty.
    Second, FDA's notification of deficiencies in, or proposal of 
modifications to, an application for a PMA or an IDE does not, as a 
general matter, create specific Federal requirements that have 
preemptive effect. Under FDA's approval and exemption programs, the 
applicant bears responsibility for preparing an acceptable application. 
FDA may notify the applicant of deficiencies and propose modifications 
to ensure that the applicant has satisfied the minimum standards for 
FDA approval or exemption, but those actions do not relieve the 
applicant of its ultimate responsibility for proposing the design, 
manufacturing, and labeling of the device. For purposes of preemption 
analysis, the applicant who modifies an application in response to an 
agency notification of deficiency or proposal for modification has 
simply achieved the same status as an applicant who had submitted a 
satisfactory application at the outset.
    Third, as the Supreme Court concluded in Lohr, FDA's general 
requirements respecting labeling (21 CFR 801.1 through 801.16), and 
good manufacturing practices, (21 CFR 820.1 through 820.198), do not 
preempt State requirements, because the general Federal requirements do 
not pertain to specific devices. (See Lohr, 116 S. Ct. at 2256-2258). 
The same controlling principle applies whether the device subject to 
those requirements is a ``grandfathered'' device that was marketed 
before the enactment of the amendments, received FDA clearance for 
marketing under section 510(k) of the act, received a PMA under section 
515 of the act, or received an IDE under section 520(g) of the act.
    Fourth, even if FDA has imposed specific Federal requirements 
respecting a particular medical device, those requirements do not 
preempt all State common law claims respecting the device. Section 521 
of the act provides for preemption only if the State common law duties 
are ``different from, or in addition to,'' the specific Federal 
requirements. In many cases, preemption will depend on the plaintiff's 
precise legal claims and theories of recovery. For example, as the 
Supreme Court noted in Lohr, if the state common law required the 
manufacturer to comply with the Federal requirements, section 521 of 
the act would not preempt that duty (116 S. Ct. at 2255-2256). 
Furthermore, the courts may be able to reconcile an apparent conflict 
between Federal and State requirements by, for example, carefully 
formulating jury instructions to limit the bases for liability to 
substantive standards of care that are consistent with any specific 
requirement that FDA has made applicable to the device.
    In every case, section 521 of the act's preemptive effect should be 
evaluated in light of the statute's precise terms. As the Supreme Court 
noted in Lohr, section 521 of the act and FDA's regulations ``require a 
careful comparison between the allegedly preempting Federal requirement 
and the allegedly preempted State requirement to determine whether they 
fall within the intended preemptive scope of the statute and 
regulations'' (116 S. Ct. at 2257-2258). The outcome of particular 
cases will frequently depend on the character and circumstances of the 
particular state law claim. FDA will continue to monitor the 
development of the law in this area and provide additional guidance as 
the need arises.
    This proposed rule would make no change in the agency's prior or 
current construction of the scope of section 521 of the act. Rather, 
the rule would simply clarify and codify the agency's longstanding 
interpretation of the scope of section 521 of the act as generally not 
preempting available legal remedies, including State common law tort 
claims.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore,

[[Page 65388]]

neither an environmental assessment nor an environmental impact 
statement is required.

V. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this rule only interprets the statute and 
does not establish any requirements, the agency certifies that this 
proposed rule will not have a significant impact on a substantial 
number of small entities. Therefore, under the Regulatory Flexibility 
Act, no further analysis is required.

VI. Request for Comments

    Interested persons may, on or before (insert date 60 days after 
date of publication in the Federal Register), submit to the Dockets 
Management Branch (address above) written comments regarding this 
proposal. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

List of Subjects in 21 CFR Part 808

    Intergovernmental relations, Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 808 be amended as follows:

PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL 
MEDICAL DEVICE REQUIREMENTS

    1. The authority citation for 21 CFR part 808 continues to read as 
follows:

    Authority: 21 U.S.C. 360j, 360k, 371.

    2. Section 808.1 is amended by adding new paragraphs (d)(11) and 
(d)(12) to read as follows:

Sec. 808.1  Scope.

 * * * * *
    (d) * * *
    (11) * * *
    (i) An FDA imposed requirement will preempt a State common law duty 
only when:
    (A) FDA has expressly imposed, by regulation or order, a specific 
substantive requirement applicable to a particular device; and
    (B) The State common law, as interpreted and applied, imposes a 
substantive requirement applicable to the same particular device that 
is different from, or in addition to, FDA's counterpart requirement.
    (ii) FDA requirements that are applicable to devices in general, or 
that are established by means other than through regulation or order, 
should not result in preemption of State tort claims.
    (12) The clearance or approval of a particular device for marketing 
under section 510(k), 515, or 520(g) of the act does not in itself 
constitute the imposition of a specific substantive requirement with 
respect to that particular device that preempts a State or local 
requirement, including a standard of care imposed under State common 
law, with respect to the same device.
* * * * *

    Dated: December 8, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-32551 Filed 12-10-97; 8:45 am]
BILLING CODE 4160-01-F