FDA 21 CFR Part 801 Medical Device Labeling


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.

801.3 Definitions.

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.

801.30 General exceptions from the requirement for the label of a device 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.

801.61 Statement of identity.

801.62 Declaration of net quantity of contents.

801.63 Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.

Subpart D - Exemptions From Adequate Directions for Use

Subpart E - Other Exemptions

Subparts F-G [Reserved] (and),

Subpart H - Special Requirements for Specific Devices

FDA 21 CFR Part 801 Medical Device Labeling:

Post a Comment


Post a Comment (0)