Title 21
PART 860
Part 860 - Medical Device Classification Procedures
PART 860 - MEDICAL DEVICE CLASSIFICATION PROCEDURES Authority:21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374. Source:43 FR 32993, July 28, 1978, unless otherwise noted. Editorial Note:Nomenclature changes to part 860 appear at 73 FR 35341, June 23, 2008.
- Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.
- Source: 43 FR 32993, July 28, 1978, unless otherwise noted.
| 21:8.0.1.1.16.1 | SUBPART A
| Subpart A - General | |
| 21:8.0.1.1.16.1.1.1 | SECTION 860.1
| 860.1 Scope. | |
| 21:8.0.1.1.16.1.1.2 | SECTION 860.3
| 860.3 Definitions. | |
| 21:8.0.1.1.16.1.1.3 | SECTION 860.5
| 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification. | |
| 21:8.0.1.1.16.1.1.4 | SECTION 860.7
| 860.7 Determination of safety and effectiveness. | |
| 21:8.0.1.1.16.1.1.5 | SECTION 860.10
| 860.10 Implants and life-supporting or life-sustaining devices. | |
| 21:8.0.1.1.16.1.1.6 | SECTION 860.15
| 860.15 Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act. | |
| 21:8.0.1.1.16.2 | SUBPART B
| Subpart B - Classification | |
| 21:8.0.1.1.16.2.1.1 | SECTION 860.84
| 860.84 Classification procedures for “preamendments devices.” | |
| 21:8.0.1.1.16.2.1.2 | SECTION 860.90
| 860.90 Consultation with panels. | |
| 21:8.0.1.1.16.3 | SUBPART C
| Subpart C - Reclassification | |
| 21:8.0.1.1.16.3.1.1 | SECTION 860.120
| 860.120 General. | |
| 21:8.0.1.1.16.3.1.2 | SECTION 860.123
| 860.123 Reclassification petition: Content and form. | |
| 21:8.0.1.1.16.3.1.3 | SECTION 860.125
| 860.125 Consultation with panels. | |
| 21:8.0.1.1.16.3.1.4 | SECTION 860.130
| 860.130 General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act. | |
| 21:8.0.1.1.16.3.1.5 | SECTION 860.132
| 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. | |
| 21:8.0.1.1.16.3.1.6 | SECTION 860.133
| 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. | |
| 21:8.0.1.1.16.3.1.7 | SECTION 860.134
| 860.134 Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act. | |
| 21:8.0.1.1.16.3.1.8 | SECTION 860.136
| 860.136 Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act. | |