§ 807.94 Format of a class III certification.
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Title 21 CFR: Food and Drugs › Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › Part 807: ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES › Subpart E: Premarket Notification Procedures › § 807.94: § 807.94 Format of a class III certification.
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(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.
(b) The statement in paragraph (a) of this section should be signed by the certifier, clearly identified as “class III certification,” and included at the beginning of the section of the premarket notification submission that sets forth the class III summary.
[59 FR 64296, Dec. 14, 1994]
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