§ 860.132 - Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the Federal Food, Drug, and Cosmetic Act.

§ 860.132 Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the act.

Cross Reference

Link to an amendment published at 83 FR 64457, Dec. 17, 2018

Federal Food, Drug, and Cosmetic Act.

(a) Sections 514(b) and 515(b) of the act Federal Food, Drug, and Cosmetic Act require the Commissioner to provide, by notice in the Federal Register, an opportunity for interested parties to request a petition to change in the classification of a device based upon new information relevant to its classification when the Commissioner initiates a proceeding either to develop a performance standard for the device if in class II , or to promulgate a regulation issue an order requiring premarket approval for the device if in class III. In either case, if

(b) If the Commissioner agrees that the new information submitted in response to a proposed order to require premarket approval of a device issued under section 515(b) of the Federal Food, Drug, and Cosmetic Act warrants a change in classification, the Commissioner

will publish in the Federal Register notice of the Commissioner's intent to initiate a proceeding

shall follow the administrative order procedures under section 513(e) of the

act and

Federal Food, Drug, and Cosmetic Act and § 860.130 to effect such a change.

(

b) The procedures for effecting

c) If the Commissioner does not agree that the new information submitted in response to a proposed order to require premarket approval of a device issued under section 515(b) of the Federal Food, Drug, and Cosmetic Act warrants a change in classification

under sections

, the Commissioner will deny the petition.

(d) The procedures under section 514(b)

and 515(b)

of the

act

Federal Food, Drug, and Cosmetic Act are as follows:

(1) Within

15

30 days after publication of the Commissioner's notice referred to in paragraph (a) of this section, an interested person files a petition for reclassification in accordance with § 860.123.

(2) The Commissioner consults with the appropriate classification panel with regard to the petition in accordance with § 860.125.

(3) Within 60 days after publication of the notice referred to in paragraph (a) of this section, the Commissioner

, by order published in the Federal Register,

either denies the petition or gives notice of

his

the intent to initiate a change in classification in accordance with § 860.130.

[43 FR 32993, July 28, 1978, as amended at 83 FR 64457, Dec. 17, 2018]