Read e-book online Code of federal regulations 21 : parts 807, 812, and 814 : PDF

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content material: Subpart A. normal provisions --
subpart B. approaches for machine institutions --
subpart C. Registration techniques for international machine institutions --
subpart D. Exemptions --
subpart E. Premarket notification procedures.

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

Example text

94 Format of a class III certification. (a) A class III certification submitted as part of a premarket notification shall state as follows: I certify, in my capacity as (position held in company), of (company name), that I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety or effectiveness problems that have been reported for the (type of device). I further certify that I am aware of the types of problems to which the (type of device) is susceptible and that, to the best of my knowledge, the following summary of the types and causes of safety or effectiveness problems about the (type of device) is complete and accurate.

G) [Reserved] (h) Carriers by reason of their receipt, carriage, holding or delivery of devices in the usual course of business as carriers. ) with a device or the benefits to be derived from the use of a device; for example, a hearing aid dispenser, optician, clinical laboratory, assembler of diagnostic x-ray systems, and personnel from a hospital, clinic, dental laboratory, orthotic or prosthetic retail facility, whose primary responsibility to the ultimate consumer is to dispense or provide a service through the use of a previously manufactured device.

D) Any other information reasonably deemed necessary by the agency. 44 PH2203_pages 10/8/03 9:16 AM Page 45 [57 FR 18066, Apr. 28, 1992, as amended at 59 FR 64295, Dec. 93 Content and format of a 510(k) statement. (a)(1) A 510(k) statement submitted as part of a premarket notification shall state as follows: I certify that, in my capacity as (the position held in company by person required to submit the premarket notification, preferably the official correspondent in the firm), of (company name), I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent.

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