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- 21 CFR 822.17 · How long will your review of my submission take?
- 21 CFR 822.18 · How will I be notified of your decision?
- 21 CFR 822.19 · What kinds of decisions may you make?
- 21 CFR 822.20 · What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct surveillance in accordance with my approved plan?
- 21 CFR 822.21 · What must I do if I want to make changes to my postmarket surveillance plan after you have approved it?
- 21 CFR 822.22 · What recourse do I have if I do not agree with your decision?
- 21 CFR 822.23 · Is the information in my submission considered confidential?
- 21 CFR 822.24 · What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?
- 21 CFR 822.25 · What are my responsibilities after my postmarket surveillance plan has been approved?
- 21 CFR 822.26 · If my company changes ownership, what must I do?
- 21 CFR 822.27 · If I go out of business, what must I do?
- 21 CFR 822.28 · If I stop marketing the device subject to postmarket surveillance, what must I do?
- 21 CFR 822.29 · May I request a waiver of a specific requirement of this part?
- 21 CFR 822.30 · May I request exemption from the requirement to conduct postmarket surveillance?
- 21 CFR 822.31 · What records am I required to keep?
- 21 CFR 822.32 · What records are the investigators in my surveillance plan required to keep?
- 21 CFR 822.33 · How long must we keep the records?
- 21 CFR 822.34 · What must I do with the records if the sponsor of the plan or an investigator in the plan changes?
- 21 CFR 822.35 · Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?
- 21 CFR 822.36 · Can you inspect and copy the records related to my postmarket surveillance plan?
- 21 CFR 822.37 · Under what circumstances would you inspect records identifying subjects?
- 21 CFR 822.38 · What reports must I submit to you?
- 21 CFR 830.3 · Definitions.
- 21 CFR 830.10 · Incorporation by reference.
- 21 CFR 830.20 · Requirements for a unique device identifier.
- 21 CFR 830.40 · Use and discontinuation of a device identifier.
- 21 CFR 830.50 · Changes that require use of a new device identifier.
- 21 CFR 830.60 · Relabeling of a device that is required to bear a unique device identifier.
- 21 CFR 830.100 · FDA accreditation of an issuing agency.
- 21 CFR 830.110 · Application for accreditation as an issuing agency.
- 21 CFR 830.120 · Responsibilities of an FDA-accredited issuing agency.
- 21 CFR 830.130 · Suspension or revocation of the accreditation of an issuing agency.
- 21 CFR 830.200 · When FDA will act as an issuing agency.
- 21 CFR 830.210 · Eligibility for use of FDA as an issuing agency.
- 21 CFR 830.220 · Termination of FDA service as an issuing agency.
- 21 CFR 830.300 · Devices subject to device identification data submission requirements.
- 21 CFR 830.310 · Information required for unique device identification.
- 21 CFR 830.320 · Submission of unique device identification information.
- 21 CFR 830.330 · Times for submission of unique device identification information.
- 21 CFR 830.340 · Voluntary submission of ancillary device identification information.
- 21 CFR 830.350 · Correction of information submitted to the Global Unique Device Identification Database.
- 21 CFR 830.360 · Records to be maintained by the labeler.
- 21 CFR 860.1 · Scope.
- 21 CFR 860.3 · Definitions.
- 21 CFR 860.5 · Confidentiality and use of data and information submitted in connection with classification and reclassification.
- 21 CFR 860.7 · Determination of safety and effectiveness.
- 21 CFR 860.10 · Implants and life-supporting or life-sustaining devices.
- 21 CFR 860.15 · Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act.
- 21 CFR 860.84 · Classification procedures for “preamendments devices.”
- 21 CFR 860.90 · Consultation with panels.
- 21 CFR 860.120 · General.
- 21 CFR 860.123 · Reclassification petition: Content and form.
- 21 CFR 860.125 · Consultation with panels.
- 21 CFR 860.130 · General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act.
- 21 CFR 860.132 · Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the Federal Food, Drug, and Cosmetic Act.
- 21 CFR 860.133 · Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act.
- 21 CFR 860.134 · Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.
- 21 CFR 860.136 · Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act.
- 21 CFR 860.200 · Purpose and applicability.
- 21 CFR 860.210 · De Novo request format.
- 21 CFR 860.220 · De Novo request content.
- 21 CFR 860.230 · Accepting a De Novo request.
- 21 CFR 860.240 · Procedures for review of a De Novo request.
- 21 CFR 860.250 · Withdrawal of a De Novo request.
- 21 CFR 860.260 · Granting or declining a De Novo request.
- 21 CFR 861.1 · Purpose and scope.
- 21 CFR 861.5 · Statement of policy.
- 21 CFR 861.7 · Contents of standards.
- 21 CFR 861.20 · Summary of standards development process.
- 21 CFR 861.24 · Existing standard as a proposed standard.
- 21 CFR 861.30 · Development of standards.
- 21 CFR 861.34 · Amendment or revocation of a standard.
- 21 CFR 861.36 · Effective dates.
- 21 CFR 861.38 · Standards advisory committees.
- 21 CFR 862.1 · Scope.
- 21 CFR 862.2 · Regulation of calibrators.
- 21 CFR 862.3 · Effective dates of requirement for premarket approval.
- 21 CFR 862.9 · Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
- 21 CFR 862.1020 · Acid phosphatase (total or prostatic) test system.
- 21 CFR 862.1025 · Adrenocorticotropic hormone (ACTH) test system.
- 21 CFR 862.1030 · Alanine amino transferase (ALT/SGPT) test system.
- 21 CFR 862.1035 · Albumin test system.
- 21 CFR 862.1040 · Aldolase test system.
- 21 CFR 862.1045 · Aldosterone test system.
- 21 CFR 862.1050 · Alkaline phosphatase or isoenzymes test system.
- 21 CFR 862.1055 · Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
- 21 CFR 862.1060 · Delta-aminolevulinic acid test system.
- 21 CFR 862.1065 · Ammonia test system.
- 21 CFR 862.1070 · Amylase test system.
- 21 CFR 862.1075 · Androstenedione test system.
- 21 CFR 862.1080 · Androsterone test system.
- 21 CFR 862.1085 · Angiotensin I and renin test system.
- 21 CFR 862.1090 · Angiotensin converting enzyme (A.C.E.) test system.
- 21 CFR 862.1092 · Anti-mullerian hormone test system.
- 21 CFR 862.1093 · Menopause test system.
- 21 CFR 862.1095 · Ascorbic acid test system.
- 21 CFR 862.1100 · Aspartate amino transferase (AST/SGOT) test system.
- 21 CFR 862.1110 · Bilirubin (total or direct) test system.
- 21 CFR 862.1113 · Bilirubin (total and unbound) in the neonate test system.
- 21 CFR 862.1115 · Urinary bilirubin and its conjugates (nonquantitative) test system.