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- 21 CFR 801.122 · Medical devices for processing, repacking, or manufacturing.
- 21 CFR 801.125 · Medical devices for use in teaching, law enforcement, research, and analysis.
- 21 CFR 801.127 · Medical devices; expiration of exemptions.
- 21 CFR 801.128 · Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.
- 21 CFR 801.150 · Medical devices; processing, labeling, or repacking.
- 21 CFR 801.405 · Labeling of articles intended for lay use in the repairing and/or refitting of dentures.
- 21 CFR 801.410 · Use of impact-resistant lenses in eyeglasses and sunglasses.
- 21 CFR 801.415 · Maximum acceptable level of ozone.
- 21 CFR 801.417 · Chlorofluorocarbon propellants.
- 21 CFR 801.422 · Prescription hearing aid labeling.
- 21 CFR 801.430 · User labeling for menstrual tampons.
- 21 CFR 801.433 · Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
- 21 CFR 801.435 · User labeling for latex condoms.
- 21 CFR 801.437 · User labeling for devices that contain natural rubber.
- 21 CFR 803.1 · What does this part cover?
- 21 CFR 803.3 · How does FDA define the terms used in this part?
- 21 CFR 803.9 · What information from the reports do we disclose to the public?
- 21 CFR 803.10 · Generally, what are the reporting requirements that apply to me?
- 21 CFR 803.11 · What form should I use to submit reports of individual adverse events and where do I obtain these forms?
- 21 CFR 803.12 · How do I submit initial and supplemental or followup reports?
- 21 CFR 803.13 · Do I need to submit reports in English?
- 21 CFR 803.15 · How will I know if you require more information about my medical device report?
- 21 CFR 803.16 · When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?
- 21 CFR 803.17 · What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
- 21 CFR 803.18 · What are the requirements for establishing and maintaining MDR files or records that apply to me?
- 21 CFR 803.19 · Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
- 21 CFR 803.20 · How do I complete and submit an individual adverse event report?
- 21 CFR 803.21 · Where can I find the reporting codes for adverse events that I use with medical device reports?
- 21 CFR 803.22 · What are the circumstances in which I am not required to file a report?
- 21 CFR 803.23 · Where can I find information on how to prepare and submit an MDR in electronic format?
- 21 CFR 803.30 · If I am a user facility, what reporting requirements apply to me?
- 21 CFR 803.32 · If I am a user facility, what information must I submit in my individual adverse event reports?
- 21 CFR 803.33 · If I am a user facility, what must I include when I submit an annual report?
- 21 CFR 803.40 · If I am an importer, what reporting requirements apply to me?
- 21 CFR 803.42 · If I am an importer, what information must I submit in my individual adverse event reports?
- 21 CFR 803.50 · If I am a manufacturer, what reporting requirements apply to me?
- 21 CFR 803.52 · If I am a manufacturer, what information must I submit in my individual adverse event reports?
- 21 CFR 803.53 · If I am a manufacturer, in which circumstances must I submit a 5-day report?
- 21 CFR 803.56 · If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?
- 21 CFR 803.58 · Foreign manufacturers.
- 21 CFR 806.1 · Scope.
- 21 CFR 806.2 · Definitions.
- 21 CFR 806.10 · Reports of corrections and removals.
- 21 CFR 806.20 · Records of corrections and removals not required to be reported.
- 21 CFR 806.30 · FDA access to records.
- 21 CFR 806.40 · Public availability of reports.
- 21 CFR 807.3 · Definitions.
- 21 CFR 807.20 · Who must register and submit a device list?
- 21 CFR 807.21 · How to register establishments and list devices.
- 21 CFR 807.22 · Times for establishment registration and device listing.
- 21 CFR 807.25 · Information required for device establishment registration and device listing.
- 21 CFR 807.26 · Additional listing information.
- 21 CFR 807.28 · Updating device listing information.
- 21 CFR 807.34 · Summary of requirements for owners or operators granted a waiver from submitting required information electronically.
- 21 CFR 807.35 · Notification of registrant.
- 21 CFR 807.37 · Public availability of establishment registration and device listing information.
- 21 CFR 807.39 · Misbranding by reference to establishment registration or to registration number.
- 21 CFR 807.40 · Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States.
- 21 CFR 807.41 · Identification of importers and persons who import or offer for import.
- 21 CFR 807.65 · Exemptions for device establishments.
- 21 CFR 807.81 · When a premarket notification submission is required.
- 21 CFR 807.85 · Exemption from premarket notification.
- 21 CFR 807.87 · Information required in a premarket notification submission.
- 21 CFR 807.90 · Format of a premarket notification submission.
- 21 CFR 807.92 · Content and format of a 510(k) summary.
- 21 CFR 807.93 · Content and format of a 510(k) statement.
- 21 CFR 807.94 · Format of a class III certification.
- 21 CFR 807.95 · Confidentiality of information.
- 21 CFR 807.97 · Misbranding by reference to premarket notification.
- 21 CFR 807.100 · FDA action on a premarket notification.
- 21 CFR 808.1 · Scope.
- 21 CFR 808.3 · Definitions.
- 21 CFR 808.5 · Advisory opinions.
- 21 CFR 808.20 · Application.
- 21 CFR 808.25 · Procedures for processing an application.
- 21 CFR 808.35 · Revocation of an exemption.
- 21 CFR 808.53 · [Reserved]
- 21 CFR 808.55 · California.
- 21 CFR 808.57-808.101 · §§ 808.57-808.101 [Reserved]
- 21 CFR 809.3 · Definitions.
- 21 CFR 809.4 · Confidentiality of submitted information.
- 21 CFR 809.10 · Labeling for in vitro diagnostic products.
- 21 CFR 809.11 · Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.
- 21 CFR 809.20 · General requirements for manufacturers and producers of in vitro diagnostic products.
- 21 CFR 809.30 · Restrictions on the sale, distribution and use of analyte specific reagents.
- 21 CFR 809.40 · Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.
- 21 CFR 810.1 · Scope.
- 21 CFR 810.2 · Definitions.
- 21 CFR 810.3 · Computation of time.
- 21 CFR 810.4 · Service of orders.
- 21 CFR 810.10 · Cease distribution and notification order.
- 21 CFR 810.11 · Regulatory hearing.
- 21 CFR 810.12 · Written request for review of cease distribution and notification order.
- 21 CFR 810.13 · Mandatory recall order.
- 21 CFR 810.14 · Cease distribution and notification or mandatory recall strategy.
- 21 CFR 810.15 · Communications concerning a cease distribution and notification or mandatory recall order.
- 21 CFR 810.16 · Cease distribution and notification or mandatory recall order status reports.
- 21 CFR 810.17 · Termination of a cease distribution and notification or mandatory recall order.
- 21 CFR 810.18 · Public notice.
- 21 CFR 812.1 · Scope.