Title 21—Food and Drugs--Volume 1
PART 808—EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
§ 808.1   Scope.
(a) Introduction. This part prescribes procedures for the submission, review, and approval of applications for exemption from Federal preemption of State and local requirements applicable to medical devices under section 521 of the Federal Food, Drug, and Cosmetic Act.
(b) General rule for State and local requirements respecting devices. Section 521(a) of the Federal Food, Drug, and Cosmetic Act contains special provisions governing the regulation of devices by States and localities. That section prescribes a general rule that after May 28, 1976, no State or political subdivision of a State may establish or continue in effect any requirement with respect to a medical device intended for human use having the force and effect of law (whether established by statute, ordinance, regulation, or court decision), which is different from, or in addition to, any requirement applicable to such device under any provision of the Federal Food, Drug, and Cosmetic Act and which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under the Federal Food, Drug, and Cosmetic Act.
(c) Exempting from preemption certain State or local requirements respecting devices. Section 521(b) of the Federal Food, Drug, and Cosmetic Act contains a provision whereby the Commissioner of Food and Drugs may, upon application by a State or political subdivision, allow imposition of a requirement which is different from, or in addition to, any requirement applicable under the Federal Food, Drug, and Cosmetic Act to the device (and which is thereby preempted) by promulgating a regulation in accordance with this part exempting the State or local requirement from preemption. The granting of an exemption does not affect the applicability to the device of any requirements under the Federal Food, Drug, and Cosmetic Act. The Commissioner may promulgate an exemption regulation for the preempted requirement if he makes either of the following findings:
(1) That the requirement is more stringent than a requirement under the Federal Food, Drug, and Cosmetic Act applicable to the device; or
(2) That 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 requirement under the Federal Food, Drug, and Cosmetic Act.
(d) Meaning of “requirements applicable to a device.” State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the Federal Food, Drug, and Cosmetic 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. There are other State or local requirements that affect devices that are not preempted by section 521(a) of the Federal Food, Drug, and Cosmetic Act because they are not “requirements applicable to a device” within the meaning of section 521(a) of the Federal Food, Drug, and Cosmetic Act. The following are examples of State or local requirements that are not regarded as preempted by section 521 of the Federal Food, Drug, and Cosmetic Act:
(1) Section 521(a) does not preempt State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g., requirements such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices.
(2) Section 521(a) does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the Federal Food, Drug, and Cosmetic Act.
(3) Section 521(a) does not preempt State or local permits, licensing, registration, certification, or other requirements relating to the approval or sanction of the practice of medicine, dentistry, optometry, pharmacy, nursing, podiatry, or any other of the healing arts or allied medical sciences or related professions or occupations that administer, dispense, or sell devices. However, regulations issued under section 520(e) or (g) of the Federal Food, Drug, and Cosmetic Act may impose restrictions on the sale, distribution, or use of a device beyond those prescribed in State or local requirements. If there is a conflict between such restrictions and State or local requirements, the Federal regulations shall prevail.
(4) Section 521(a) does not preempt specifications in contracts entered into by States or localities for procurement of devices.
(5) Section 521(a) does not preempt criteria for payment of State or local obligations under Medicaid and similar Federal, State or local health-care programs.
(6)(i) Section 521(a) does not preempt State or local requirements respecting general enforcement, e.g., requirements that State inspection be permitted of factory records concerning all devices, registration, and licensing requirements for manufacturers and others, and prohibition of manufacture of devices in unlicensed establishments. However, Federal regulations issued under sections 519 and 520(f) of the Federal Food, Drug, and Cosmetic Act may impose requirements for records and reports and good manufacturing practices beyond those prescribed in State or local requirements. If there is a conflict between such regulations and State or local requirements, the Federal regulations shall prevail.
(ii) Generally, section 521(a) does not preempt a State or local requirement prohibiting the manufacture of adulterated or misbranded devices. Where, however, such a prohibition has the effect of establishing a substantive requirement for a specific device, e.g., a specific labeling requirement, then the prohibition will be preempted if the requirement is different from, or in addition to, a Federal requirement established under the Federal Food, Drug, and Cosmetic Act. In determining whether such a requirement is preempted, the determinative factor is how the requirement is interpreted and enforced by the State or local government and not the literal language of the statute, which may be identical to a provision in the Federal Food, Drug, and Cosmetic Act.
(7) Section 521(a) does not preempt State or local provisions respecting delegations of authority and related administrative matters relating to devices.
(8) Section 521(a) does not preempt a State or local requirement whose sole purpose is raising revenue or charging fees for services, registration, or regulatory programs.
(9) Section 521(a) does not preempt State or local requirements of the types that have been developed under the Atomic Energy Act of 1954 (42 U.S.C. 2011 note), as amended, Subchapter C—Electronic Product Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly the Radiation Control for Health and Safety Act of 1968), and other Federal statutes, until such time as the Food and Drug Administration issues specific requirements under the Federal Food, Drug, and Cosmetic Act applicable to these types of devices.
(10) Part 820 of this chapter (21 CFR part 820) (CGMP requirements) does not preempt remedies created by States or Territories of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
(e) Determination of equivalence or difference of requirements applicable to a device. It is the responsibility of the Food and Drug Administration, subject to review by Federal courts, to determine whether a State or local requirement is equal to, or substantially identical to, requirements imposed by or under the Federal Food, Drug, and Cosmetic Act, or is different from, or in addition to, such requirements, in accordance with the procedures provided by this part. However, it is the responsibility of States and political subdivisions to determine initially whether to seek exemptions from preemption. Any State or political subdivision whose requirements relating to devices are preempted by section 521(a) may petition the Commissioner of Food and Drugs for exemption from preemption, in accordance with the procedures provided by this part.
(f) Applicability of Federal requirements respecting devices. The Federal requirement with respect to a device applies whether or not a corresponding State or local requirement is preempted or exempted from preemption. As a result, if a State or local requirement that the Food and Drug Administration has exempted from preemption is not as broad in its application as the Federal requirement, the Federal requirement applies to all circumstances not covered by the State or local requirement.
(g) Exemptions not applicable to certain State or local government requirements specifically related to hearing products. An exemption under this part shall not apply to any State or local government law, regulation, order, or other requirement specifically related to hearing products, including any requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access over-the-counter hearing aids, that:
(1) Would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter hearing aids, as defined under section 520(q) of the Federal Food, Drug, and Cosmetic Act, through in-person transactions, by mail, or online; and
(2) Is different from, in addition to, or otherwise not identical to, the regulations issued under section 709(b) of the FDA Reauthorization Act of 2017.
§ 808.3   Definitions.
Compelling local conditions includes any factors, considerations, or circumstances prevailing in, or characteristic of, the geographic area or population of the State or political subdivision that justify exemption from preemption.
More stringent refers to a requirement of greater restrictiveness or one that is expected to afford to those who may be exposed to a risk of injury from a device a higher degree of protection than is afforded by a requirement applicable to the device under the Federal Food, Drug, and Cosmetic Act.
Political subdivision or locality means any lawfully established local governmental unit within a State which unit has the authority to establish or continue in effect any requirement having the force and effect of law with respect to a device intended for human use.
State means any State or Territory of the United States, including but not limited to, the District of Columbia and the Commonwealth of Puerto Rico.
Substantially identical to refers to the fact that a State or local requirement does not significantly differ in effect from a Federal requirement.
§ 808.5   Advisory opinions.
(a) Any State, political subdivision, or other interested person may request an advisory opinion from the Commissioner with respect to any general matter concerning preemption of State or local device requirements or with respect to whether the Food and Drug Administration regards particular State or local requirements, or proposed requirements, as preempted.
(1) Such an advisory opinion may be requested and may be granted in accordance with § 10.85 of this chapter.
(2) The Food and Drug Administration, in its discretion and after consultation with the State or political subdivision, may treat a request by a State or political subdivision for an advisory opinion as an application for exemption from preemption under § 808.20.
(b) The Commissioner may issue an advisory opinion relating to a State or local requirement on his own initiative when he makes one of the following determinations:
(1) A requirement with respect to a device for which an application for exemption from preemption has been submitted under § 808.20 is not preempted by section 521(a) of the Federal Food, Drug, and Cosmetic Act because it is: (i) Equal to or substantially identical to a requirement under the Federal Food, Drug, and Cosmetic Act applicable to the device, or (ii) is not a requirement within the meaning of section 521 of the Federal Food, Drug, and Cosmetic Act and therefore is not preempted;
(2) A proposed State or local requirement with respect to a device is not eligible for exemption from preemption because the State or local requirement has not been issued in final form. In such a case, the advisory opinion may indicate whether the proposed requirement would be preempted and, if it would be preempted, whether the Food and Drug Administration would propose to grant an exemption from preemption;
(3) Issuance of such an advisory opinion is in the public interest.
§ 808.20   Application.
(a) Any State or political subdivision may apply to the Food and Drug Administration for an exemption from preemption for any requirement that it has enacted and that is preempted. An exemption may only be granted for a requirement that has been enacted, promulgated, or issued in final form by the authorized body or official of the State or political subdivision so as to have the force and effect of law. However, an application for exemption may be submitted before the effective date of the requirement.
(b) An application for exemption shall be in the form of a letter to the Commissioner of Food and Drugs and shall be signed by an individual who is authorized to request the exemption on behalf of the State or political subdivision. An original and two copies of the letter and any accompanying material, as well as any subsequent reports or correspondence concerning an application, shall be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The outside wrapper of any application, report, or correspondence should indicate that it concerns an application for exemption from preemption of device requirements.
(c) For each requirement for which an exemption is sought, the application shall include the following information to the fullest extent possible, or an explanation of why such information has not been included:
(1) Identification and a current copy of any statute, rule, regulation, or ordinance of the State or political subdivision considered by the State or political subdivision to be a requirement which is preempted, with a reference to the date of enactment, promulgation, or issuance in final form. The application shall also include, where available, copies of any legislative history or background materials pertinent to enactment, promulgation, or issuance of the requirement, including hearing reports or studies concerning development or consideration of the requirement. If the requirement has been subject to any judicial or administrative interpretations, the State or political subdivision shall furnish copies of such judicial or administrative interpretations.
(2) A comparison of the requirement of the State or political subdivision and any applicable Federal requirements to show similarities and differences.
(3) Information on the nature of the problem addressed by the requirement of the State or political subdivision.
(4) Identification of which (or both) of the following bases is relied upon for seeking an exemption from preemption:
(i) The requirement is more stringent than a requirement applicable to a device under the Federal Food, Drug, and Cosmetic Act. If the State or political subdivision relies upon this basis for exemption from preemption, the application shall include information, data, or material showing how and why the requirement of the State or political subdivision is more stringent than requirements under the Federal Food, Drug, and Cosmetic Act.
(ii) 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 requirement under the Federal Food, Drug, and Cosmetic 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 Federal Food, Drug, and Cosmetic 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.
§ 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.
(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 Staff 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 final rule in subpart C of this part identifying any requirement in the application for which exemption from preemption is granted, or conditionally granted, and any requirement in the application for which exemption from preemption is not granted.
(2) The Commissioner may issue a regulation granting or conditionally granting an application for an exemption from preemption for any requirement if the Commissioner makes either of the following findings:
(i) The requirement is more stringent than a requirement applicable to the device under the Federal Food, Drug, and Cosmetic Act;
(ii) The requirement is required by compelling local conditions, and compliance with the requirement would not cause the device to be in violation of any requirement applicable to the device under the Federal Food, Drug, and Cosmetic Act.
(3) The Commissioner may not grant an application for an exemption from preemption for any requirement with respect to a device if the Commissioner determines that the granting of an exemption would not be in the best interest of public health, taking into account the potential burden on interstate commerce.
(h) An advisory opinion pursuant to § 808.5 or a regulation pursuant to paragraph (g) of this section constitutes final agency action.
§ 808.35   Revocation of an exemption.
(a) An exemption from preemption pursuant to a regulation under this part shall remain effective until the Commissioner revokes such exemption.
(b) The Commissioner may by regulation, in accordance with § 808.25, revoke an exemption from preemption for any of the following reasons:
(1) An exemption may be revoked upon the effective date of a newly established requirement under the Federal Food, Drug, and Cosmetic Act which, in the Commissioner's view, addresses the objectives of an exempt requirement and which is described, when issued, as preempting a previously exempt State or local requirement.
(2) An exemption may be revoked upon a finding that there has occurred a change in the bases listed in § 808.20(c)(4) upon which the exemption was granted.
(3) An exemption may be revoked if it is determined that a condition placed on the exemption by the regulation under which the exemption was granted has not been met or is no longer being met.
(4) An exemption may be revoked if a State or local jurisdiction fails to submit records as provided in § 808.20(c)(6).
(5) An exemption may be revoked if a State or local jurisdiction to whom the exemption was originally granted requests revocation.
(6) An exemption may be revoked if it is determined that it is no longer in the best interests of the public health to continue the exemption.
(c) An exemption that has been revoked may be reinstated, upon request from the State or political subdivision, if the Commissioner, in accordance with the procedures in § 808.25, determines that the grounds for revocation are no longer applicable except that the Commissioner may permit abbreviated submissions of the documents and materials normally required for an application for exemption under § 808.20.
§ 808.53   [Reserved]
§ 808.55   California.
The following California medical device requirements are preempted under section 521(a) of the Federal Food, Drug, and Cosmetic Act, and FDA has denied them exemption from preemption:
(a) Medical devices; general provisions. Sherman Food, Drug, and Cosmetic Law, Division 21 of the California Health and Safety Code, sections 26207, 26607, 26614, 26615, 26618, 26631, 26640, and 26441, to the extent that they apply to devices; and
(b) Ophthalmic devices; quality standards. California Business and Professions Code, section 2541.3 to the extent that it requires adoption of the American National Standards Institute standards Z-80.1 and Z-80.2.
§§ 808.57--808.101   [Reserved]