C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES › Subpart A—General

21 C.F.R. § 814.19

Product development protocol (PDP)

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A class III device for which a product development protocol has been declared completed by FDA under this chapter will be considered to have an approved PMA.

Notes of Decisions
Cited in 2 cases, 2014–2015 · leading case: Ricardo Rodriguez v. Am. Med. Sys., Inc, 597 F. App'x 226 (5th Cir. 2014).
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Ricardo Rodriguez v. Am. Med. Sys., Inc, 597 F. App'x 226 (5th Cir. 2014). “§ 360e(f)(1); see also 21 C.F.R. § 814.19 (“A class III device for which a product development protocol has been declared completed by the FDA under this chapter will be considered to have an approved PMA.”
Stanfield v. Boston Sci. Corp., 166 F. Supp. 3d 873 (S.D. Tex. 2015). · cites it 2× “3610 (Date PMA or notice of completion of PDP is required “for implantable pacemaker pulse generator”); 21 C.F.R. 814.19 (“A class III device for which a product development protocol has been declared completed by the FDA under this chapter will be considered to have an approved…”
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