CFR - Code of Federal Regulations Title 21

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 860 MEDICAL DEVICE CLASSIFICATION PROCEDURES

Subpart A - General
   § 860.1 - Scope.
   § 860.3 - Definitions.
   § 860.5 - Confidentiality and use of data and information submitted in connection with classification and reclassification.
   § 860.7 - Determination of safety and effectiveness.
   § 860.10 - Implants and life-supporting or life-sustaining devices.
   § 860.15 - Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act.

Subpart B - Classification
   § 860.84 - Classification procedures for "preamendments devices."
   § 860.90 - Consultation with panels.

Subpart C - Reclassification
   § 860.120 - General.
   § 860.123 - Reclassification petition: Content and form.
   § 860.125 - Consultation with panels.
   § 860.130 - General procedures under section 513(e) 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 Federal Food, Drug, and Cosmetic Act.
   § 860.133 - Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act.
   § 860.134 - Procedures for reclassification of "postamendments devices" under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.
   § 860.136 - Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act.

Subpart D - De Novo Classification
   § 860.200 - Purpose and applicability.
   § 860.210 - De Novo request format.
   § 860.220 - De Novo request content.
   § 860.230 - Accepting a De Novo request.
   § 860.240 - Procedures for review of a De Novo request.
   § 860.250 - Withdrawal of a De Novo request.
   § 860.260 - Granting or declining a De Novo request.

Authority: 21 U.S.C. 321(h), 353(g), 360c, 360d, 360e, 360i, 360j, 371, 374.
Source: 43 FR 32993, July 28, 1978, unless otherwise noted.