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compliance with the requirement (4) Section 521(a) does not preempt would not cause the device to be in vio- specifications in contracts entered into lation of any applicable requirement by States or localities for procurement under the act.

of devices. (d) State or local requirements are (5) Section 521(a) does not preempt preempted only when the Food and criteria for payment of State or local Drug Administration has established obligations under Medicaid and similar specific counterpart regulations or

Federal, State or local health-care prothere are other specific requirements grams. applicable to a particular device under

(6)(i) Section 521(a) does not preempt the act, thereby making any existing

State or local requirements respecting divergent State or local requirements

general enforcement, e.g., requireapplicable to the device different from,

ments that State inspection be peror in addition to, the specific Food and

mitted of factory records concerning Drug Administration requirements.

all devices, registration, and licensing There are other State or local require

requirements for manufacturers and ments that affect devices that are not

others, and prohibition of manufacture

of devices in unlicensed establishpreempted by section 521(a) of the act because they are not “requirements ap

ments. However, Federal regulations plicable to a device" within the mean

issued under sections 519 and 520(f) of ing of section 521(a) of the act. The fol

the act may impose requirements for lowing are examples of State or local

records and reports and good manufacrequirements that are not regarded as

turing practices beyond those prepreempted by section 521 of the act:

scribed in State or local requirements.

If there is a conflict between such regu(1) Section 521(a) does not preempt

lations and State or local requireState or local requirements of general

ments, the Federal regulations shall applicability where the purpose of the

prevail. requirement relates either to other

(ii) Generally, section 521(a) does not products in addition to devices (e.g., requirements such as general electrical

preempt a State or local requirement

prohibiting the manufacture of adulcodes, and the Uniform Commercial

terated or misbranded devices. Where, Code (warranty of fitness)), or to unfair

however, such a prohibition has the eftrade practices in which the require

fect of establishing a substantive rements are not limited to devices.

quirement for a specific device, e.g., a (2) Section 521(a) does not preempt

specific labeling requirement, then the State or local requirements that are

prohibition will be preempted if the reequal to, or substantially identical to,

quirement is different from, or in addirequirements imposed by or under the

tion to, a Federal requirement estabact.

lished under the act. In determining (3) Section 521(a) does not preempt whether such a requirement is preState or local permits, licensing, reg- empted, the determinative factor is istration, certification, or other re

how the requirement is interpreted and quirements relating to the approval or enforced by the State or local governsanction of the practice of medicine, ment and not the literal language of dentistry, optometry, pharmacy, nurs- the statute, which may be identical to ing, podiatry, or any other of the heal- a provision in the act. ing arts or allied medical sciences or (7) Section 521(a) does not preempt related professions or occupations that State or local provisions respecting administer, dispense, or sell devices. delegations of authority and related However, regulations issued under sec- administrative matters relating to detion 520(e) or (g) of the act may impose vices. restrictions on the sale, distribution, (8) Section 521(a) does not preempt a or use of a device beyond those pre- State or local requirement whose sole scribed in State or local requirements. purpose is raising revenue or charging If there is a conflict between such re- fees for services, registration, or regustrictions and State or local require- latory programs. ments, the Federal regulations shall (9) Section 521(a) does not preempt prevail.

State or local requirements of the types that have been developed under acteristic of, the geographic area or the Atomic Energy act of 1954 (42 population of the State or political U.S.C. 2011 note), as amended, the Ra- subdivision that justify exemption diation Control for Health and Safety from preemption. Act of 1968 (Pub. L. 90-602 (42 U.S.C. (c) More stringent refers to a require263b et seq.)) and other Federal stat- ment of greater restrictiveness or one utes, until such time as the Food and

that is expected to afford to those who Drug Administration issues specific re

may be exposed to a risk of injury from quirements under the Federal Food,

a device a higher degree of protection Drug, and Cosmetic Act applicable to than is afforded by a requirement apthese types of devices.

plicable to the device under the act. (10) Part 820 of this chapter (21 CFR

(d) Political subdivision or locality part 820) (CGMP requirements) does

means any lawfully established local not preempt remedies created

by

governmental unit within a State States or Territories of the United

which unit has the authority to estabStates, the District of Columbia, or the

lish or continue in effect any requireCommonwealth of Puerto Rico.

ment having the force and effect of law (e) It is the responsibility of the Food

with respect to a device intended for and Drug Administration, subject to

human use. review by Federal courts, to determine whether a State or local requirement is

(e) State means a State, American

Samoa, the Canal Zone, the Commonequal to, or substantially identical to,

wealth of Puerto Rico, the District of requirements imposed by or under the act, or is different from, or in addition

Columbia, Guam, Johnston Island,

Kingman Reef, Midway Island, the to, such requirements, in accordance

Trust Territory of the Pacific Islands, with the procedures provided by this part. However, it is the responsibility

the Virgin Islands, and Wake Island. of States and political subdivisions to

(f) Substantially identical to refers to determine initially whether to seek ex

the fact that a State or local requireemptions from preemption. Any State

ment does not significantly differ in efor political subdivision whose require

fect from a Federal requirement. ments relating to devices are pre

$ 808.5 Advisory opinions. empted by section 521(a) may petition the Commissioner of Food and Drugs (a) Any State, political subdivision, for exemption from preemption, in ac- or other interested person may request cordance with the procedures provided an advisory opinion from the Commisby this part.

sioner with respect to any general mat(f) The Federal requirement with re- ter concerning preemption of State or spect to a device applies whether or not local device requirements or with rea corresponding State or local require- spect to whether the Food and Drug ment is preempted or exempted from Administration regards particular preemption. As a result, if a State or State or local requirements, or prolocal requirement that the Food and posed requirements, as preempted. Drug Administration has exempted (1) Such an advisory opinion may be from preemption is not as broad in its requested and may be granted in acapplication as the Federal require- cordance with $10.85 of this chapter. ment, the Federal requirement applies (2) The Food and Drug Administrato all circumstances not covered by the tion, in its discretion and after conState or local requirement.

sultation with the State or political [43 FR 18665, May 2, 1978, as amended at 45

subdivision, may treat a request by a FR 67336, Oct. 10, 1980; 61 FR 52654, Oct. 7,

State or political subdivision for an ad1996)

visory opinion as an application for ex

emption from preemption under 8 808.3 Definitions.

$ 808.20. (a) Act means the Federal Food, (b) The Commissioner may issue an Drug, and Cosmetic Act.

advisory opinion relating to a State or (b) Compelling local conditions includes local requirement on his own initiative any factors, considerations, or cir- when he makes one of the following decumstances prevailing in, or char- terminations:

(1) A requirement with respect to a should indicate that it concerns an apdevice for which an application for ex- plication for exemption from preempemption from preemption has been sub- tion of device requirements. mitted under $808.20 is not preempted (c) For each requirement for which by section 521(a) of the act because it

an exemption is sought, the application is: (i) Equal to or substantially iden

shall include the following information tical to a requirement under the act

to the fullest extent possible, or an exapplicable to the device, or (11) is not a planation of why such information has requirement within the meaning of sec

not been included: tion 521 of the act and therefore is not preempted;

(1) Identification and a current copy (2) A proposed State or local require- of any statute, rule, regulation, or orment with respect to a device is not el dinance of the State or political subigible for exemption from preemption

division considered by the State or pobecause the State or local requirement litical subdivision to be a requirement has not been issued in final form. In which is preempted, with a reference to such a case, the advisory opinion may

the date of enactment, promulgation, indicate whether the proposed require- or issuance in final form. The applicament would be preempted and, if it tion shall also include, where availwould be preempted, whether the Food able, copies of any legislative history and Drug Administration would pro- or background materials pertinent to pose to grant an exemption from pre- enactment, promulgation, or issuance emption;

of the requirement, including hearing (3) Issuance of such an advisory opin- reports or studies concerning developion is in the public interest.

ment or consideration of the require

ment. If the requirement has been subSubpart B-Exemption Procedures ject to any judicial or administrative

interpretations, the State or political 8808.20 Application.

subdivision shall furnish copies of such (a) Any State or political subdivision judicial or administrative interpretamay apply to the Food and Drug Ad- tions. ministration for an exemption from (2) A comparison of the requirement preemption for any requirement that it of the State or political subdivision has enacted and that is preempted. An and any applicable Federal requireexemption may only be granted for a

ments to show similarities and difrequirement that has been enacted,

ferences. promulgated, or issued in final form by

(3) Information on the nature of the the authorized body or official of the

problem addressed by the requirement State or political subdivision so as to

of the State or political subdivision. have the force and effect of law. How

(4) Identification of which (or both) ever, an application for exemption may

of the following bases is relied upon for be submitted before the effective date

seeking an exemption from preempof the requirement.

tion: (b) An application for exemption shall be in the form of a letter to the

(i) The requirement is more stringent Commissioner of Food and Drugs and

than a requirement applicable to a deshall be signed by an individual who is

vice under the act. If the State or poauthorized to request the exemption on

litical subdivision relies upon this behalf of the State or political subdivi

basis for exemption from preemption, sion. An original and two copies of the

the application shall include informaletter and any accompanying material, tion, data, or material showing how as well as any subsequent reports or

and why the requirement of the State correspondence concerning an applica- or political subdivision is more strintion, shall be submitted to the Dockets gent than requirements under the act. Management Branch (HFA-305), Food (ii) The requirement is required by and Drug Administration, rm. 1-23, compelling local conditions, and com12420 Parklawn Dr. Rockville, MD pliance with the requirement would 20857. The outside wrapper of any appli- not cause the device to be in violation cation, report, or correspondence of any applicable requirement under

the act. If the State or political subdivision relies upon this basis for exemption from preemption, the application shall include information, data, or material showing why compliance with the requirement of the State or political subdivision would not cause a device to be in violation of any applicable requirement under the act and why the requirement is required by compelling local conditions. The application shall also explain in detail the compelling local conditions that justify the requirement.

(5) The title of the chief administrative or legal officers of that State or local agency that has primary responsibility for administration of the requirement.

(6) When requested by the Food and Drug Administration, any records concerning administration of any requirement which is the subject of an exemption or an application for an exemption from preemption.

(7) Information on how the public health may be benefitted and how interstate commerce may be affected, if an exemption is granted.

(8) Any other pertinent information respecting the requirement voluntarily submitted by the applicant.

(d) If litigation regarding applicability of the requirement is pending, the State or political subdivision may so indicate in its application and request expedited action on such application.

(c) After receipt of an application meeting the requirements of $808.20, the Commissioner shall review such application and determine whether to grant or deny an exemption from preemption for each requirement which is the subject of the application. The Commissioner shall then issue in the FEDERAL REGISTER a proposed regulation either to grant or to deny an exemption from preemption. The Commissioner shall also issue in the FEDERAL REGISTER a notice of opportunity to request an oral hearing before the Commissioner or the Commissioner's designee.

(d) A request for an oral hearing may be made by the State or political subdivision or any other interested person. Such request shall be submitted to the Dockets Management Branch within the period of time prescribed in the notice and shall include an explanation of why an oral hearing, rather than submission of written comments only, is essential to the presentation of views on the application for exemption from preemption and the proposed regulation.

(e) If a timely request for an oral hearing is made, the Commissioner shall review such a request and may grant a legislative-type informal oral hearing pursuant to part 15 of this chapter by publishing in the FEDERAL REGISTER a notice of the hearing in accordance with $ 15.20 of this chapter. The scope of the oral hearing shall be limited to matters relevant to the application for exemption from preemption and the proposed regulation. Oral or written presentations at the oral hearing which are not relevant to the application shall be excluded from the administrative record of the hearing.

(f) If a request for hearing is not timely made or a notice of appearance is not filed pursuant to $15.21 of this chapter, the Commissioner shall consider all written comments submitted and publish a final rule in accordance with paragraph (g) of this section.

(g)(1) The Commissioner shall review all written comments submitted on the proposed rule and the administrative record of the oral hearing, if an oral hearing has been granted, and shall publish in the FEDERAL REGISTER a

(43 FR 18665, May 2, 1978; 43 FR 22010, May 23, 1978, as amended at 49 FR 3646, Jan. 30, 1984; 59 FR 14365, Mar. 28, 1994)

$ 808.25 Procedures for processing an

application. (a) Upon receipt of an application for an exemption from preemption submitted in accordance with $ 808.20, the Commissioner shall notify the State or political subdivision of the date of such receipt.

(b) If the Commissioner finds that an application does not meet the requirements of $808.20, he shall notify the State or political subdivision of the deficiencies in the application and of the opportunity to correct such deficiencies. A deficient application may be corrected at any time.

final rule in subpart C of this part iden- (3) An exemption may be revoked if it tifying any requirement in the applica- is determined that a condition placed tion for which exemption from preemp- on the exemption by the regulation tion is granted, or conditionally grant- under which the exemption was granted, and any requirement in the applica- ed has not been met or is no longer tion for which exemption from preemp- being met. tion is not granted.

(4) An exemption may be revoked if a (2) The Commissioner may issue a State or local jurisdiction fails to subregulation granting or conditionally mit records as provided in $ 808.20(c)(6). granting an application for an exemp- (5) An exemption may be revoked if a tion from preemption for any require- State or local jurisdiction to whom the ment if the Commissioner makes ei

exemption was originally granted rether of the following findings:

quests revocation. (i) The requirement is more stringent

(6) An exemption may be revoked if it than a requirement applicable to the

is determined that it is no longer in device under the act;

the best interests of the public health (ii) The requirement is required by

to continue the exemption. compelling local conditions, and com

(c) An exemption that has been repliance with the requirement would

voked may be reinstated, upon request not cause the device to be in violation

from the State or political subdivision, of any requirement applicable to the

if the Commissioner, in accordance device under the act.

with the procedures in $ 808.25, deter(3) The Commissioner may not grant

mines that the grounds for revocation an application for an exemption from

are no longer applicable except that preemption for any requirement with

the Commissioner may permit abbrerespect to a device if the Commissioner

viated submissions of the documents determines that the granting of an ex

and materials normally required for an emption would not be in the best inter

application for exemption under est of public health, taking into ac

$ 808.20. count the potential burden on interstate commerce. (h) An advisory opinion pursuant to

Subpart C-Listing of Specific $808.5 or a regulation pursuant to para

State and Local Exemptions graph (g) of this section constitutes final agency action.

$ 808.53 Arizona.

The following Arizona medical device 8808.35 Revocation of an exemption.

requirements are preempted by section (a) An exemption from preemption 521(a) of the act, and the Food and pursuant to a regulation under this Drug Administration has denied them part shall remain effective until the exemptions from preemption under secCommissioner revokes such exemption. tion 521(b) of the act:

(b) The Commissioner may by regula- (a) Arizona Revised Statutes, Chaption, in accordance with $ 808.25, revoke ter 17, sections 36–1901.7(s) and 36an exemption from preemption for any 1901.7(t). of the following reasons:

(b) Arizona Code of Revised Regula(1) An exemption may be revoked

tions, Title 9, Article 3, sections R9-16 upon the effective date of a newly es

303 and R9-16-304. tablished requirement under the act which, in the Commissioner's view, ad

[45 FR 67336, Oct. 10, 1980) dresses the objectives of an exempt re

$ 808.55 California. quirement and which is described, when issued, as preempting a pre- (a) The following California medical viously exempt State or local require- device requirements are enforceable ment.

notwithstanding section 521 of the act (2) An exemption may be revoked because the Food and Drug Adminisupon a finding that there has occurred tration exempted them from preempa change in the bases listed in tion under section 521(b) of the act: $ 808.20(c)(4) upon which the exemption Business and Professions Code sections was granted.

3365 and 3365.6.

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