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(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.

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)

8808.67 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)

[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)

8 808.59 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)

8 808.69 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)

$ 808.61 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

$ 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, and Drug Administration has denied it Chapter 93, Section 74, except as pro- an exemption from preemption under vided in paragraph (6) of the Section, section 521(b) of the act: Nebraska Reon the condition that, in enforcing this vised Statutes, section 71requirement, Massachusetts apply the 4712(2)(c)(vii). definition of “used hearing aid" in $ 801.420(a)(6) of this chapter.

[45 FR 67336, Oct. 10, 1980) (b) The following Massachusetts med

$ 808.80 New Jersey. ical device requirements are preempted by section 521(a) of the act, and the

(a) The following New Jersey medical Food and Drug Administration has de- device requirements are enforceable nied them exemptions from preemption

notwithstanding section 521(a) of the under section 521(b) of the act.

act because the Food and Drug Admin(1) Massachusetts General Laws, istration has exempted them from preChapter 93, Section 72, except as pro

emption under section 521(b) of the act: vided in paragraph (a) of this section. (1) New Jersey Statutes Annotated,

(2) Massachusetts General Laws, section 45:9A-23 on the condition that, Chapter 93, Section 74, to the extent in enforcing this requirement, New Jerthat it requires that the sales receipt sey apply the definition of "used hearcontain a statement that State law re- ing aid" in 8801.420(a)(6) of this chapquires a medical examination and a ter; hearing test evaluation before the sale (2) New Jersey Statutes Annotated, of a hearing aid.

sections 45:9A-24 and 45:9A-25; [45 FR 67326, Oct. 10, 1980)

(3) Chapter 3, Section 5 of the Rules

and Regulations adopted pursuant to 8808.73 Minnesota.

New Jersey Statutes Annotated 45:9A-1 The following Minnesota medical de

et seq. except as provided in paragraph vice requirements are preempted by

(b) of this section. section 521(a) of the act, and the Food

(b) The following New Jersey medical and Drug Administration has denied

device requirement is preempted by

section 521(a) of the act, and the Food them an exemption from preemption under section 521(b) of the act: Min

and Drug Administration has denied it nesota Statutes, sections 145.43 and

an exemption from preemption under 145.44.

section 521(b) of the act: Chapter 3,

Section 5 of the Rules and Regulations [45 FR 67336, Oct. 10, 1980)

adopted pursuant to New Jersey Stat

utes Annotated 45:9A-1 et seq. to the ex8808.74 Mississippi.

tent that it requires testing to be conThe following Mississippi medical de- ducted in an environment which meets vice requirement is preempted by sec- exceeds the American National tion 521(a) of the act, and the Food and Standards Institute S3.1 Standard. Drug Administration has denied it an exemption from preemption under sec

(45 FR 67337, Oct. 10, 1980) tion 521(b) of the act: Mississippi Code,

8 808.81 New Mexico. section 73-143(g)(9).

The following New Mexico medical [45 FR 67336, Oct. 10, 1980)

device requirement is enforceable not8808.77 Nebraska.

withstanding section 521(a) of the act

because the Food and Drug Adminis(a) The following Nebraska medical

tration has exempted it from preempdevice requirement is enforceable not

tion under section 521(b) of the act: withstanding section 521(a) of the act

New Mexico Statutes Annotated, secbecause the Food and Drug Adminis

tion 67-36–16(F). tration has exempted it from preemption under section 521(b) of the act: Ne- [45 FR 67337, Oct. 10, 1980) braska Revised Statutes, section 714712(2)(c)(vi).

$ 808.82 New York. (b) The following Nebraska medical (a) The following New York medical device requirement is preempted by device requirements are enforceable section 521(a) of the act, and the Food notwithstanding section 521(a) of the

or

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 8801.420(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.

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)

(45 FR 67337, Oct. 10, 1980)

8 808.85 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 8801.420(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.

8808.88 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]

8 808.89 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 549–2.1, 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)

8808.87 Oregon.

(a) The following Oregon medical device requriements are enforceable notwithstanding section 521(a) of the act

(45 FR 67337, Oct. 10, 1980)

nied 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)

$ 808.93 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 8801.420(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)

8 808.101 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)

$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]

PART 809-IN VITRO DIAGNOSTIC

PRODUCTS FOR HUMAN USE

Subpart A-General Provisions

Sec. 809.3 Definitions. 809.4 Confidentiality of submitted informa

tion.

8808.98 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 26–15(a) on the condition that in enforcing section 30-26-15(a) West Virginia apply the definition of “used hearing aid" in 8801.420(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 de

Subpart B-Labeling 809.10 Labeling for in vitro diagnostic products.

Subpart C-Requirements for

Manufacturers and Producers 809.20 General requirements for manufac

turers and producers of in vitro diag

nostic products. 809.30 Restrictions on the sale, distribution

and use of analyte specific reagents. 809.40 Restrictions on the sale, distribution,

and use of OTC test sample collection

systems for drugs of abuse testing. AUTHORITY: 21 U.S.C. 331, 351, 352, 355, 360b, 3600, 3600, 360h, 360i, 360j, 371, 372, 374, 381.

Subpart A-General Provisions ticular product class or as provided in

paragraph (e) of this section. Section 88093 Definitions.

201(k) of the act provides that "a re(a) In vitro diagnostic products are quirement made by or under authority those reagents, instruments, and sys- of this act that any word, statement, tems intended for use in the diagnosis or other information appear on the of disease or other conditions, includ- label shall not be considered to be coming a determination of the state of plied with unless such word, statement, health, in order to cure, mitigate, or other information also appears on treat, or prevent disease or its the outside container or wrapper, if sequelae. Such products are intended any there be, of the retail package of for use in the collection, preparation, such article, or is easily legible and examination of specimens taken

through the outside container or wrapfrom the human body. These products

per." are devices as defined in section 201(h)

(1) The proprietary name and estabof the Federal Food, Drug, and Cos

lished name (common or usual name), metic Act (the act), and may also be bi

if any. ological products subject to section 351

(2) The intended use or uses of the of the Public Health Service Act. (b) A product class is all those prod

product. ucts intended for use for a particular

(3) For a reagent, a declaration of the determination or for a related group of

established name (common or usual determinations or products with com

name), if any, and quantity, proportion mon or related characteristics or those

or concentration of each reactive inintended for common or related uses. A

gredient; and for a reagent derived class may be further divided into sub

from biological material, the source classes when appropriate.

and a measure of its activity. The (c) (Reserved]

quantity, proportion, concentration, or (d) Act means the Federal Food, activity shall be stated in the system Drug, and Cosmetic Act.

generally used and recognized by the (41 FR 6903, Feb. 13, 1976, as amended at 45

intended user, e.g., metric, interFR 7484, Feb. 1, 1980)

national units, etc.

(4) A statement of warnings or pre8 809.4 Confidentiality of submitted in- cautions for users as established in the formation,

regulations contained in 16 CFR part Data and information submitted 1500 and any other warnings approunder $809.10(c) that are shown to fall priate to the hazard presented by the within the exemption established in product; and a statement “For In Vitro $20.61 of this chapter shall be treated Diagnostic Use” and any other limiting as confidential by the Food and Drug statements appropriate to the intended Administration and any person to use of the product. whom the data and information are re- (5) For a reagent, appropriate storage ferred. The Food and Drug Administra

instructions adequate to protect the tion will determine whether informa

stability of the product. When application submitted will be treated as con

ble, these instructions shall include fidential in accordance with the provi

such information as conditions of temsions of part 20 of this chapter.

perature, light, humidity, and other [45 FR 7484, Feb. 1, 1980)

pertinent factors. For products requir

ing manipulation, such as reconstituSubpart B-Labeling

tion and/or mixing before use, appro

priate storage instructions shall be 8809.10 Labeling for in vitro diag- provided for the reconstituted or mixed nostic products.

product which is to be stored in the (a) The label for an in vitro diag- original container. The basis for such nostic product shall state the following instructions shall be determined by reinformation, except where such infor- liable, meaningful, and specific test mation is not applicable, or as other- methods such as those described in wise specified in a standard for a par- $211.166 of this chapter.

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