C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES › Subpart E—Premarket Notification Procedures

21 C.F.R. § 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]
Notes of Decisions
Cited in 3 cases, 1995–2019 · leading case: prod.liab.rep. (Cch) P 14,260 Lora Lohr, Michael Lohr, Her Husband v. Medtronic, Inc., a Foreign Corp., 56 F.3d 1335 (11th Cir. 1995).
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prod.liab.rep. (Cch) P 14,260 Lora Lohr, Michael Lohr, Her Husband v. Medtronic, Inc., a Foreign Corp., 56 F.3d 1335 (11th Cir. 1995). “Surprisingly, Appellee does not cite to 21 C.F.R. § 807.94 , which requires Class III 510(k) *1349 submissions to be identified as such.”
Burningham v. Wright Med., 2019 UT 56 (Utah 2019). “21 C.F.R. § 807.94 (a). 10 There is a third process, not implicated here, of gaining market approval by designating the device as innovative technology and marketing it under an “investigational device exemption” (IDE).”
Lohr v. Medtronic, Inc. (11th Cir. 1995). “Moreover, Appellee identifies nothing in the statute's text, or even in its legislative history, to suggest that grandfathering 21 Surprisingly, Appellee does not cite to 21 C.F.R. § 807.94 , which requires Class III 510(k) submissions to be identified as such.”
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