FDA 21 CFR Part 801 Medical Device Labeling:
Click the title below for complete guidelines
Table of contents
Subpart A - General Labeling Provisions
801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
801.4 Meaning of intended uses.
801.5 Medical devices; adequate directions for use.
801.6 Medical devices; misleading statements.
801.15 Medical devices; prominence of required label statements; use of symbols in labeling.
801.16 Medical devices; Spanish-language version of certain required statements.
801.18 Format of dates provided on a medical device label.
Subpart B - Labeling Requirements for Unique Device Identification
801.20 Label to bear a unique device identifier.
801.35 Voluntary labeling of a device with a unique device identifier.
801.40 Form of a unique device identifier.
801.45 Devices that must be directly marked with a unique device identifier.
801.50 Labeling requirements for stand-alone software.
801.55 Request for an exception from or alternative to a unique device identifier requirement.
801.57 Discontinuation of legacy FDA identification numbers assigned to devices.
Subpart C - Labeling Requirements for Over-the-Counter Devices
801.60 Principal display panel.
801.62 Declaration of net quantity of contents.
Subpart D - Exemptions From Adequate Directions for Use
Subparts F-G [Reserved] (and),
Subpart H - Special Requirements for Specific Devices
FDA 21 CFR Part 801 Medical Device Labeling:
0 Comments