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]

(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]

§ 808.94 Utah.

To the extent that the age restriction on sales of cigarettes and smokeless tobacco found in the Utah Code Annotated, section 76-10-104, is preempted under section 521(a) of the act, the Food and Drug Administration has exempted it from preemption under section 521(b) of the act.

[62 FR 63274, Nov. 28, 1997]

§ 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 preemp

tion 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 3026-15(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]

(a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act.

(b) A product class is all those products intended for use for a particular determination or for a related group of determinations or products with common or related characteristics or those intended for common or related uses. A class may be further divided into subclasses when appropriate. (c) [Reserved]

(d) Act means the Federal Food, Drug, and Cosmetic Act.

[41 FR 6903, Feb. 13, 1976, as amended at 45 FR 7484, Feb. 1, 1980]

§ 809.4 Confidentiality of submitted in

formation.

Data and information submitted under §809.10(c) that are shown to fall within the exemption established in § 20.61 of this chapter shall be treated as confidential by the Food and Drug Administration and any person to whom the data and information are referred. The Food and Drug Administration will determine whether information submitted will be treated as confidential in accordance with the provisions of part 20 of this chapter.

[45 FR 7484, Feb. 1, 1980]

§ 809.5 Exemption from batch certification requirements for in vitro antibiotic susceptibility devices subject to section 507 of the act.

(a) Antibiotic susceptibility devices subject to section 507 of the act are exempt from the batch certification requirements of part 431 of this chapter if the following conditions are met:

(1) The antibiotic susceptibility device is approved for marketing under an appropriate antibiotic application.

(2) The antibiotic susceptibility device is packaged and labeled for dispensing in accordance with the applicable regulation (monograph) in this chapter except where other labeling has been approved in an applicable antibiotic application.

(3) The bulk antibiotic drug used in preparing the antibiotic susceptibility device meets the standards of identity, strength, quality, and purity specified in the applicable regulation (monograph) in this chapter except where other standards have been approved in an applicable antibiotic application.

(4) The antibiotic susceptibility device meets the standards of identity, strength, quality, and purity specified in the applicable regulation (monograph) in this chapter except where other standards have been approved in an applicable antibiotic application.

(b) For each antibiotic susceptibility device subject to an exemption under this section, an approved antibiotic application is regarded to be an approved

premarket approval application under section 515 of the act.

(c) Nothing in this section prevents a manufacturer from applying for batch certification of an antibiotic susceptibility device as provided in section 507(c) of the act.

(d) All exemptions from batch certification requirements for antibiotic susceptibility devices under this section are subject to the conditions of effectiveness under § 809.6.

[47 FR 39160, Sept. 7, 1982, as amended at 53 FR 11252, Apr. 6, 1988]

EFFECTIVE DATE NOTE: At 64 FR 404, Jan. 5, 1999, §809.5 was removed, effective May 20, 1999.

§ 809.6 Conditions on the effectiveness of exemptions of antibiotic susceptibility devices from batch certification requirements.

(a) If at any time after an exemption from batch certification requirements for an antibiotic susceptibility device has been granted, the Commissioner finds on the basis of new information before the agency with respect to such exempted device evaluated together with the evidence available to the agency when such exemption was granted, that certification of each batch is necessary to ensure its safety and efficacy of use, the Commissioner shall act immediately to revoke all exemptions from batch certification requirements granted for such device.

(b) If the Commissioner finds that the person granted an exemption from batch certification requirements for an antibiotic susceptibility device has failed to comply with the requirements of section 507 of the act and the regulations promulgated thereunder; or if the Commissioner finds that the requirements of § 809.5 have not been met; or if the Commissioner finds that the petition for exemption from batch certification contains any false statements of fact, the Commissioner may revoke the exemption from batch certification requirements immediately and require batch certification of the device until such person shows adequate cause why the exemption from batch certification requirements should be reinstated.

(c) If the Commissioner repeals or suspends an exemption from batch certification requirements for an anti

biotic susceptibility device, a notice to that effect and the reasons therefor will be published in the FEDERAL REGISTER.

(d) Any person who contests the revocation or suspension or denial of reinstatement of an exemption from batch certification requirements for an antibiotic susceptibility device shall have an opportunity for a regulatory hearing before the Food and Drug Administration under part 16 of this chapter.

[47 FR 39160, Sept. 7, 1982]

EFFECTIVE DATE NOTE: At 64 FR 404, Jan. 5, 1999, §809.6 was removed, effective May 20, 1999.

Subpart B-Labeling

§ 809.10 Labeling for in vitro diag. nostic products.

(a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise specified in a standard for a particular product class or as provided in paragraph (e) of this section. Section 201(k) of the act provides that "a requirement made by or under authority of this act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper."

(1) The proprietary name and established name (common or usual name), if any.

(2) The intended use or uses of the product.

(3) For a reagent, a declaration of the established name (common or usual name), if any, and quantity, proportion or concentration of each reactive ingredient; and for a reagent derived from biological material, the source and a measure of its activity. The quantity, proportion, concentration, or activity shall be stated in the system generally used and recognized by the intended user, e.g., metric, international units, etc.

(4) A statement of warnings or precautions for users as established in the regulations contained in 16 CFR part 1500 and any other warnings appropriate to the hazard presented by the product; and a statement "For In Vitro Diagnostic Use" and any other limiting statements appropriate to the intended use of the product.

(5) For a reagent, appropriate storage instructions adequate to protect the stability of the product. When applicable, these instructions shall include such information as conditions of temperature, light, humidity, and other pertinent factors. For products requiring manipulation, such as reconstitution and/or mixing before use, appropriate storage instructions shall be provided for the reconstituted or mixed product which is to be stored in the original container. The basis for such instructions shall be determined by reliable, meaningful, and specific test methods such as those described in § 211.166 of this chapter.

(6) For a reagent, a means by which the user may be assured that the product meets appropriate standards of identity, strength, quality and purity at the time of use. This shall be provided, both for the product as provided and for any resultant reconstituted or mixed product, by including on the label one or more of the following:

(i) An expiration date based upon the stated storage instructions.

(ii) A statement of an observable indication of an alteration of the product, e.g., turbidity, color change, precipitate, beyond its appropriate standards.

(iii) Instructions for a simple method by which the user can reasonably determine that the product meets its appropriate standards.

(7) For a reagent, a declaration of the net quantity of contents, expressed in terms of weight or volume, numerical count, or any combination of these or other terms which accurately reflect the contents of the package. The use of metric designations is encouraged, wherever appropriate. If more than a single determination may be performed using the product, any statement of the number of tests shall be consistent with instructions for use and amount of material provided.

(8) Name and place of business of manufacturer, packer, or distributor.

(9) A lot or control number, identified as such, from which it is possible to determine the complete manufacturing history of the product.

(i) If it is a multiple unit product, the lot or control number shall permit tracing the identity of the individual units.

(ii) For an instrument, the lot or control number shall permit tracing the identity of all functional subassemblies.

(iii) For multiple unit products which require the use of included units together as a system, all units should bear the same lot or control number, if appropriate, or other suitable uniform identification should be used.

(10) Except that for items in paragraphs (a) (1) through (9) of this section: (i) In the case of immediate containers too small or otherwise unable to accommodate a label with sufficient space to bear all such information and which are packaged within an outer container from which they are removed for use, the information required by paragraphs (a) (2), (3), (4), (5), (6) (ii), (iii) and (7) of this section may appear in the outer container labeling only.

(ii) In any case in which the presence of this information on the immediate container will interfere with the test, the information may appear on the outside container or wrapper rather than on the immediate container label.

(b) Labeling accompanying each product, e.g., a package insert, shall state in one place the following information in the format and order specified below, except where such information is not applicable, or as specified in a standard for a particular product class. The labeling for a multiple-purpose instrument used for diagnostic purposes, and not committed to specific diagnostic procedures or systems, may bear only the information indicated in paragraphs (b) (1), (2), (6), (14), and (15) of this section. The labeling for a reagent intended for use as a replacement in a diagnostic system may be limited to that information necessary to identify the reagent adequately and to describe its proper use in the system.