Download Code of federal regulations 21 : parts 807, 812, and 814 : PDF

content material: Subpart A. common provisions --
subpart B. approaches for equipment institutions --
subpart C. Registration systems for international gadget institutions --
subpart D. Exemptions --
subpart E. Premarket notification procedures.

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Extra resources for Code of federal regulations 21 : parts 807, 812, and 814 : medical device approval

Example text

18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981; 53 FR 11252, Apr. 6, 1988; 62 FR 4165, Jan, 29, 1997; 62 FR 12096, Mar. 3 Definitions. (a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. C. 301-392)). (b) Custom device means a device that: (1) Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist; (2) Is not generally available to, or generally used by, other physicians or dentists; (3) Is not generally available in finished form for purchase or for dispensing upon prescription; (4) Is not offered for commercial distribution through labeling or advertising; and (5) Is intended for use by an individual patient named in the order of a physician or dentist, and is 62 PH2203_pages 10/8/03 9:16 AM Page 63 to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.

B) Custom device means a device that: (1) Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist; (2) Is not generally available to, or generally used by, other physicians or dentists; (3) Is not generally available in finished form for purchase or for dispensing upon prescription; (4) Is not offered for commercial distribution through labeling or advertising; and (5) Is intended for use by an individual patient named in the order of a physician or dentist, and is 62 PH2203_pages 10/8/03 9:16 AM Page 63 to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.

10 Waivers. 18 Import and export requirements. 19 Address for IDE correspondence. 38 Application. Investigational plan. Report of prior investigations. FDA action on applications. Supplemental applications. Treatment use of an investigational device. Confidentiality of data and information. 47 General responsibilities of sponsors. FDA and IRB approval. Selecting investigators and monitors. Informing investigators. Monitoring investigations. 24 of this chapter. 66 IRB composition, duties, and functions.

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