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. § 814.2

Purpose

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The purpose of this part is to establish an efficient and thorough device review process—

(a) To facilitate the approval of PMA's for devices that have been shown to be safe and effective and that otherwise meet the statutory criteria for approval; and

(b) To ensure the disapproval of PMA's for devices that have not been shown to be safe and effective or that do not otherwise meet the statutory criteria for approval. This part shall be construed in light of these objectives.

Notes of Decisions
Cited in 5 cases, 1996–2015 · leading case: United States ex rel. Modglin v. DJO Global Inc., 48 F. Supp. 3d 1362 (C.D. Cal. 2014).
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United States ex rel. Modglin v. DJO Global Inc., 48 F. Supp. 3d 1362 (C.D. Cal. 2014). “21 C.F.R. § 814.2 (a). It is “a ‘rigorous’ process in which the manufacturer submits to the FDA extensive study reports, design specifications and descriptions, samples of the device, and proposed labeling, and the FDA conducts a comprehensive review and *1370 evaluation of all…”
Worthy v. Collagen Corp., 967 S.W.2d 360 (Tex. 1998). “’ 21 C.F.R. § 814.2 (a).”); Steele v. Collagen Corp.”
United States ex rel. Modglin v. DJO Global Inc., 114 F. Supp. 3d 993 (C.D. Cal. 2015). “21 C.F.R. § 814.2 (a). It is “a ‘rigorous’ process in which the manufacturer submits extensive study reports, design specifications and descriptions, samples of the device, and proposed labeling to the FDA, and the FDA conducts a comprehensive review and evaluation of all the…”
Milkiewicz v. Baxter Healthcare Corp., 963 F. Supp. 1150 (M.D. Fla. 1996). “The FDA publishes the notice of approval in the Federal Register and includes a “detailed summary of the information respecting the safety and effectiveness of the device which was the basis for the order approving the PMA.”
Mattingly v. Medtronic, Inc., 486 F. Supp. 2d 964 (E.D. Mo. 2007). “See 21 C.F.R. § 814.2 (a). Thus, Plaintiffs contention that Defendant represented that the device was "safe and effective" and that it was not because of the alleged defect necessarily is seeking to impose requirements that are "different from or in addition to" those required…”
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