tion 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 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 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 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 (c) An exemption that has been revoked may be reinstated, upon request from the State or political subdivision, if the Commissioner, in accordance with the procedures in §808.25, determines that the grounds for revocation are no longer applicable except that the Commissioner may permit abbreviated submissions of the documents and materials normally required for an application for exemption under §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. Subpart C-Listing of Specific § 808.53 Arizona. The following Arizona medical device requirements are preempted by section 521(a) of the act, and the Food and Drug Administration has denied them exemptions from preemption under section 521(b) of the act: (a) Arizona Revised Statutes, Chapter 17, sections 36-1901.7(s) and 361901.7(t). (b) Arizona Code of Revised Regulations, Title 9, Article 3, sections R9-16303 and R9-16-304. [45 FR 67336, Oct. 10, 1980] §808.55 California. (a) The following California medical device requirements are enforceable notwithstanding section 521 of the act because the Food and Drug Administration exempted them from preemption under section 521(b) of the act: Business and Professions Code sections 3365 and 3365.6. (b) The following California medical device requirements are preempted by section 521 of the act, and FDA has denied them an exemption from preemption: (1) Sherman Food, Drug, and Cosmetic Law (Division 21 of the California Health and Safety Code), sections 26207, 26607, 26614, 26615, 26618, 26631, 26640, and 26641, to the extent that they apply to devices. (2) Sherman Food, Drug, and Cosmetic Law, section 26463(m) to the extent that it applies to hearing aids. (3) Business and Professions Code section 2541.3, to the extent that it requires adoption of American National Standards Institute standards Z-80.1 and Z-80.2. [45 FR 67324, Oct. 10, 1980] $808.57 Connecticut. The following Connecticut medical device requirements are enforceable notwithstanding section 521(a) of the act because the Food and Drug Administration has exempted them from preemption under section 521(b) of the act: Connecticut General Statutes, sections 20-403 and 20-404. [45 FR 67336, Oct. 10, 1980] §808.59 Florida. The following Florida medical device requirements are preempted by section 521(a) of the act, and the Food and Drug Administration has denied them an exemption from preemption under section 521(b) of the act: (a) Florida Statutes, section 468.135(5). (b) Florida Administrative Code, section 10D-48.25(26). [45 FR 67336, Oct. 10, 1980] § 808.61 Hawaii. (a) The following Hawaii medical device requirements are enforceable notwithstanding section 521 of the act, because the Food and Drug Administration has exempted them from preemption under section 521(b) of the act: Hawaii Revised Statutes, chapter 451A, §14.1, subsection (a) with respect to medical examination of a child 10 years of age or under, and subsection (c). (b) The following Hawaii medical device requirements are preempted by section 521(a) of the act, and the Food and Drug Administration has denied them exemption from preemption: Hawaii Revised Statutes, chapter 451A, §14.1, subsection (a) to the extent that it requires a written authorization by a physician and does not allow adults to waive this requirement for personal, as well as religious reasons, and subsection (b). [50 FR 30699, July 29, 1985; 50 FR 32694, Aug. 14, 1985] §808.67 Kentucky. The following Kentucky medical device requirement is preempted by section 521(a) of the act, and the Food and Drug Administration has denied it an exemption from preemption under section 521(b) of the act: Kentucky Revised Statutes, section 334.200(1). [45 FR 67336, Oct. 10, 1980] § 808.69 Maine. (a) The following Maine medical device requirement is enforceable notwithstanding section 521(a) of the act because the Food and Drug Administration has exempted it from preemption under section 521(b) of the act: Maine Revised Statutes Annotated, Title 32, section 1658-C, on the condition that, in enforcing this requirement, Maine apply the definition of "used hearing aid" in §801.420(a)(6) of this chapter. (b) The following Maine medical device requirement is preempted by section 521(a) of the act, and the Food and Drug Administration has denied it an exemption from preemption under section 521(b) of the act: Maine Revised Statutes Annotated, Title 32, section 1658-D and the last sentence of section 1658-E. [45 FR 67336, Oct. 10, 1980] § 808.71 Massachusetts. (a) The following Massachusetts medical device requirements are enforceable notwithstanding section 521 of the act because the Food and Drug Administration has exempted them from preemption under section 521(b) of the act: (1) Massachusetts General Laws, Chapter 93, Section 72, to the extent that it requires a hearing test evaluation for a child under the age of 18. (2) Massachusetts General Laws, Chapter 93, Section 74, except as provided in paragraph (6) of the Section, on the condition that, in enforcing this requirement, Massachusetts apply the definition of "used hearing aid" in §801.420(a)(6) of this chapter. (b) The following Massachusetts medical device requirements are preempted by section 521(a) of the act, and the Food and Drug Administration has denied them exemptions from preemption under section 521(b) of the act. (1) Massachusetts General Laws, Chapter 93, Section 72, except as provided in paragraph (a) of this section. (2) Massachusetts General Laws, Chapter 93, Section 74, to the extent that it requires that the sales receipt contain a statement that State law requires a medical examination and a hearing test evaluation before the sale of a hearing aid. [45 FR 67326, Oct. 10, 1980] §808.73 Minnesota. The following Minnesota medical device requirements are preempted by section 521(a) of the act, and the Food and Drug Administration has denied them an exemption from preemption under section 521(b) of the act: Minnesota Statutes, sections 145.43 and 145.44. [45 FR 67336, Oct. 10, 1980] § 808.74 Mississippi. The following Mississippi medical device requirement is preempted by section 521(a) of the act, and the Food and Drug Administration has denied it an exemption from preemption under section 521(b) of the act: Mississippi Code, section 73-14-3(g)(9). [45 FR 67336, Oct. 10, 1980] § 808.77 Nebraska. (a) The following Nebraska medical device requirement is enforceable notwithstanding section 521(a) of the act because the Food and Drug Administration has exempted it from preemption under section 521(b) of the act: Nebraska Revised Statutes, section 714712(2)(c)(vi). (b) The following Nebraska medical device requirement is preempted by section 521(a) of the act, and the Food and Drug Administration has denied it an exemption from preemption under section 521(b) of the act: Nebraska Revised Statutes, section 4712(2)(c)(vii). [45 FR 67336, Oct. 10, 1980] 71 §808.80 New Jersey. (a) The following New Jersey medical device requirements are enforceable notwithstanding section 521(a) of the act because the Food and Drug Administration has exempted them from preemption under section 521(b) of the act: (1) New Jersey Statutes Annotated, section 45:9A-23 on the condition that, in enforcing this requirement, New Jersey apply the definition of "used hearing aid" in §801.420(a)(6) of this chapter; (2) New Jersey Statutes Annotated, sections 45:9A-24 and 45:9A-25; (3) Chapter 3, Section 5 of the Rules and Regulations adopted pursuant to New Jersey Statutes Annotated 45:9A-1 et seq. except as provided in paragraph (b) of this section. (b) The following New Jersey medical device requirement is preempted by section 521(a) of the act, and the Food and Drug Administration has denied it an exemption from preemption under section 521(b) of the act: Chapter 3, Section 5 of the Rules and Regulations adopted pursuant to New Jersey Statutes Annotated 45:9A-1 et seq. to the extent that it requires testing to be conducted in an environment which meets or exceeds the American National Standards Institute S3.1 Standard. [45 FR 67337, Oct. 10, 1980] §808.81 New Mexico. The following New Mexico medical device requirement is enforceable notwithstanding section 521(a) of the act because the Food and Drug Administration has exempted it from preemption under section 521(b) of the act: New Mexico Statutes Annotated, section 67-36-16(F). [45 FR 67337, Oct. 10, 1980] §808.82 New York. (a) The following New York medical device requirements are enforceable notwithstanding section 521(a) of the act because the Food and Drug Administration has exempted them from preemption under section 521(b) of the act: (1) General Business Law, Article 37, sections 784(3) and (4). (2) Official Compilation of Codes, Rules and Regulations of the State of New York, Chapter V, Title 19, Subchapter G, section 191.10 and section 191.11(a) on the condition that, in enforcing these requirements, New York apply the definition of "used hearing aid" in §801.420(a)(6) of this chapter and section 191.11(b), (c), (d), and (e). (b) The following New York medical device requirements are preempted by section 521(a) of the act, and the Food and Drug Administration has denied them an exemptions from preemption under section 521(b) of the act: (1) General Business Law, Article 37, section 784.1. (2) Official Compilation of Codes, Rules and Regulations of the State of New York, Chapter V, Title 19, Subchapter G, sections 191.6, 191.7, 191.8, and 191.9. [45 FR 67337, Oct. 10, 1980] §808.85 Ohio. (a) The following Ohio medical device requirement is enforceable notwithstanding section 521(a) of the act because the Food and Drug Administration has exempted it from preemption under section 521(b) of the act: Ohio Revised Code, section 4747.09, the first two sentences with respect to disclosure of information to purchasers on the condition that, in enforcing these requirements, Ohio apply the definition of "used hearing aid" in §801.420(a)(6) of this chapter. (b) The following Ohio medical device requirement is preempted by section 521(a) of the act, and the Food and Drug Administration has denied it an exemption from preemption under section 521(b) of the act: Ohio Revised Code, section 4747.09, the last two sentences with respect to medical examination of children. [45 FR 67337, Oct. 10, 1980] §808.87 Oregon. (a) The following Oregon medical device requriements are enforceable notwithstanding section 521(a) of the act because the Food and Drug Administration has exempted them from preemption under section 521(b) of the act: Oregon Revised Statutes, section 694.036 on the condition that, in enforcing this requirement, Oregon apply the definition of "used hearing aid" in §801.420(a)(6) of this chapter. (b) The following Oregon medical device requirements are preempted by section 521(a) of the act, and the Food and Drug Administration has denied them exemptions from preemption under section 521(b) of the act: Oregon Revised Statutes, sections 694.136(6) and (7). [45 FR 67337, Oct. 10, 1980, as amended at 53 FR 11252, Apr. 6, 1988] §808.88 Pennsylvania. (a) The following Pennsylvania medical device requirements are enforceable notwithstanding section 521(a) of the act because the Food and Drug Administration has exempted them from preemption under section 521(b) of the act: 35 Purdon's Statutes 6700, section 504(4) on the condition that, in enforcing this requirement, Pennsylvania apply the definition of "used hearing aid" in § 801.420(a)(6) of this chapter; section 506; and, section 507(2). (b) The following Pennsylvania medical device requirement is preempted by section 521(a) of the act and the Food and Drug Administration has denied it an exemption from preemption under section 521(b) of the act: 35 Purdon's Statutes 6700, section 402. [45 FR 67326, Oct. 10, 1980] § 808.89 Rhode Island. The following Rhode Island medical device requirements are preempted by section 521(a) of the act, and the Food and Drug Administration has denied them an exemption from preemption under section 521(b) of the act: Rhode Island General Laws, Section 5-49-2.1, and Section 2.2, to the extent that Section 2.2 requires hearing aid dispensers to keep copies of the certificates of need. [45 FR 67337, Oct. 10, 1980] § 808.93 Texas. (a) The following Texas medical device requirement is enforceable notwithstanding section 521(a) of the act because the Food and Drug Administration has exempted it from preemption under section 521(b) of the act: Vernon's Civil Statutes, Article 4566, section 14(b) on the condition that, in enforcing this requirement, Texas apply the definition of "used hearing aid" in §801.420(a)(6) of this chapter. (b) The following Texas medical device requirement is preempted by section 521(a) of the act, and the Food and Drug Administration has denied it an exemption from preemption under section 521(b) of the act: Vernon's Civil Statutes, Article 4566, section 14(d). [45 FR 67337, Oct. 10, 1980] § 808.97 Washington. (a) The following Washington medical device requirement is enforceable notwithstanding section 521(a) of the act because the Food and Drug Administration has exempted it from preemption under section 521(b) of the act: Revised Code of Washington 18.35.110(2)(e) (i) and (iii) on the condition that it is enforced in addition to the applicable requirements of this chapter. (b) The following Washington medical device requirements are preempted by section 521(a) of the act, and the Food and Drug Administration has denied them an exemption from preemption under section 521(b) of the act: Revised Code of Washington 18.35.110(2)(e)(ii). [45 FR 67337, Oct. 10, 1980] § 808.98 West Virginia. (a) The following West Virginia medical device requirements are enforceable notwithstanding section 521(a) of the act because the Food and Drug Administration has exempted them from preemption: West Virginia Code, sections 30-26-14 (b) and (c) and section 30-2615(a) on the condition that in enforcing section 30-26-15(a) West Virginia apply the definition of “used hearing aid” in § 801.420(a)(6) of this chapter. (b) The following West Virginia medical device requirement is preempted by section 521(a) of the act, and the Food and Drug Administration has denied it an exemption from preemption under section 521(b) of the act: West Virginia Code, section 30-26-14(a). [45 FR 67337, Oct. 10, 1980, as amended at 53 FR 35314, Sept. 13, 1988] §808.101 District of Columbia. (a) The following District of Columbia medical device requirements are enforceable, notwithstanding section 521 of the act, because the Food and Drug Administration has exempted them from preemption under section 521(b) of the act: (1) Act 2-79, section 5, to the extent that it requires an audiological evaluation for children under the age of 18. (2) Act 2-79, section 6, on the condition that in enforcing section 6(a)(5), the District of Columbia apply the definition of "used hearing aid" in §801.420(a)(6) of this chapter. (b) The following District of Columbia medical device requirement is preempted by section 521(a) of the act, and the Food and Drug Administration has denied it an exemption from preemption under section 521(b) of the act: Act 2-79, section 5, except as provided in paragraph (a) of this section. [46 FR 59236, Dec. 4, 1981] |