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- 21 CFR 812.2 · Applicability.
- 21 CFR 812.3 · Definitions.
- 21 CFR 812.5 · Labeling of investigational devices.
- 21 CFR 812.7 · Prohibition of promotion and other practices.
- 21 CFR 812.10 · Waivers.
- 21 CFR 812.18 · Import and export requirements.
- 21 CFR 812.19 · Address for IDE correspondence.
- 21 CFR 812.20 · Application.
- 21 CFR 812.25 · Investigational plan.
- 21 CFR 812.27 · Report of prior investigations.
- 21 CFR 812.28 · Acceptance of data from clinical investigations conducted outside the United States.
- 21 CFR 812.30 · FDA action on applications.
- 21 CFR 812.35 · Supplemental applications.
- 21 CFR 812.36 · Treatment use of an investigational device.
- 21 CFR 812.38 · Confidentiality of data and information.
- 21 CFR 812.40 · General responsibilities of sponsors.
- 21 CFR 812.42 · FDA and IRB approval.
- 21 CFR 812.43 · Selecting investigators and monitors.
- 21 CFR 812.45 · Informing investigators.
- 21 CFR 812.46 · Monitoring investigations.
- 21 CFR 812.47 · Emergency research under § 50.24 of this chapter.
- 21 CFR 812.60 · IRB composition, duties, and functions.
- 21 CFR 812.62 · IRB approval.
- 21 CFR 812.64 · IRB's continuing review.
- 21 CFR 812.65 · [Reserved]
- 21 CFR 812.66 · Significant risk device determinations.
- 21 CFR 812.100 · General responsibilities of investigators.
- 21 CFR 812.110 · Specific responsibilities of investigators.
- 21 CFR 812.119 · Disqualification of a clinical investigator.
- 21 CFR 812.140 · Records.
- 21 CFR 812.145 · Inspections.
- 21 CFR 812.150 · Reports.
- 21 CFR 814.1 · Scope.
- 21 CFR 814.2 · Purpose.
- 21 CFR 814.3 · Definitions.
- 21 CFR 814.9 · Confidentiality of data and information in a premarket approval application (PMA) file.
- 21 CFR 814.15 · Research conducted outside the United States.
- 21 CFR 814.17 · Service of orders.
- 21 CFR 814.19 · Product development protocol (PDP).
- 21 CFR 814.20 · Application.
- 21 CFR 814.37 · PMA amendments and resubmitted PMAs.
- 21 CFR 814.39 · PMA supplements.
- 21 CFR 814.40 · Time frames for reviewing a PMA.
- 21 CFR 814.42 · Filing a PMA.
- 21 CFR 814.44 · Procedures for review of a PMA.
- 21 CFR 814.45 · Denial of approval of a PMA.
- 21 CFR 814.46 · Withdrawal of approval of a PMA.
- 21 CFR 814.47 · Temporary suspension of approval of a PMA.
- 21 CFR 814.80 · General.
- 21 CFR 814.82 · Postapproval requirements.
- 21 CFR 814.84 · Reports.
- 21 CFR 814.100 · Purpose and scope.
- 21 CFR 814.102 · Designation of HUD status.
- 21 CFR 814.104 · Original applications.
- 21 CFR 814.106 · HDE amendments and resubmitted HDE's.
- 21 CFR 814.108 · Supplemental applications.
- 21 CFR 814.110 · New indications for use.
- 21 CFR 814.112 · Filing an HDE.
- 21 CFR 814.114 · Timeframes for reviewing an HDE.
- 21 CFR 814.116 · Procedures for review of an HDE.
- 21 CFR 814.118 · Denial of approval or withdrawal of approval of an HDE.
- 21 CFR 814.120 · Temporary suspension of approval of an HDE.
- 21 CFR 814.122 · Confidentiality of data and information.
- 21 CFR 814.124 · Institutional Review Board requirements.
- 21 CFR 814.126 · Postapproval requirements and reports.
- 21 CFR 820.1 · Scope.
- 21 CFR 820.3 · Definitions.
- 21 CFR 820.5 · [Reserved]
- 21 CFR 820.7 · Incorporation by reference.
- 21 CFR 820.10 · Requirements for a quality management system.
- 21 CFR 820.20-820.30 · §§ 820.20-820.30 [Reserved]
- 21 CFR 820.35 · Control of records.
- 21 CFR 820.40 · [Reserved]
- 21 CFR 820.45 · Device labeling and packaging controls.
- 21 CFR 821.1 · Scope.
- 21 CFR 821.2 · Exemptions and variances.
- 21 CFR 821.3 · Definitions.
- 21 CFR 821.4 · Imported devices.
- 21 CFR 821.20 · Devices subject to tracking.
- 21 CFR 821.25 · Device tracking system and content requirements: manufacturer requirements.
- 21 CFR 821.30 · Tracking obligations of persons other than device manufacturers: distributor requirements.
- 21 CFR 821.50 · Availability.
- 21 CFR 821.55 · Confidentiality.
- 21 CFR 821.60 · Retention of records.
- 21 CFR 822.1 · What does this part cover?
- 21 CFR 822.2 · What is the purpose of this part?
- 21 CFR 822.3 · How do you define the terms used in this part?
- 21 CFR 822.4 · Does this part apply to me?
- 21 CFR 822.5 · How will I know if I must conduct postmarket surveillance?
- 21 CFR 822.6 · When will you notify me that I am required to conduct postmarket surveillance?
- 21 CFR 822.7 · What should I do if I do not agree that postmarket surveillance is appropriate?
- 21 CFR 822.8 · When, where, and how must I submit my postmarket surveillance plan?
- 21 CFR 822.9 · What must I include in my submission?
- 21 CFR 822.10 · What must I include in my surveillance plan?
- 21 CFR 822.11 · What should I consider when designing my plan to conduct postmarket surveillance?
- 21 CFR 822.12 · Do you have any information that will help me prepare my submission or design my postmarket surveillance plan?
- 21 CFR 822.13 · [Reserved]
- 21 CFR 822.14 · May I reference information previously submitted instead of submitting it again?
- 21 CFR 822.15 · How long must I conduct postmarket surveillance of my device?
- 21 CFR 822.16 · What will you consider in the review of my submission?