FDA 21 CFR Part 888 Orthopedic Devices

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FDA 21 CFR Part 888 Orthopedic Devices:


FDA 21 CFR Part 888 Orthopedic Devices: (a) This part sets forth the classification of orthopedic devices intended for human use that are in commercial distribution.


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Table of contents

Subpart A - General Provisions

888.1 Scope.

888.3 Effective dates of requirement for premarket approval.

888.5 Resurfacing technique.

888.6 Degree of constraint.

888.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B - Diagnostic Devices

888.1100 Arthroscope.

888.1240 AC-powered dynamometer.

888.1250 Nonpowered dynamometer.

888.1500 Goniometer.

888.1520 Nonpowered goniometer.

Subpart C [Reserved]

Subpart D - Prosthetic Devices (and)

Subpart E - Surgical Devices


FDA 21 CFR Part 888 Orthopedic Devices:

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