Click the title below for complete guidelines
Table of contents
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
“pre amendments 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
“post amendments 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 xxx
FDA 21 CFR Part 860 Medical Device Classification Procedures:
