(a) This section implements sections 515 and 515A of the act by providing procedures for the premarket approval of medical devices intended for human use.
(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
(c) This part applies to any class III medical device, unless exempt under section 520(g) of the act, that:
(1) Was not on the market (introduced or delivered for introduction into commerce for commercial distribution) before May 28, 1976, and is not substantially equivalent to a device on the market before May 28, 1976, or to a device first marketed on, or after that date, which has been classified into class I or class II; or
(2) Is required to have an approved premarket approval application (PMA) or a declared completed product development protocol under a regulation issued under section 515(b) of the act; or
(3) Was regulated by FDA as a new drug or antibiotic drug before May 28, 1976, and therefore is governed by section 520(1) of the act.
(d) This part amends the conditions to approval for any PMA approved before the effective date of this part. Any condition to approval for an approved PMA that is inconsistent with this part is revoked. Any condition to approval for an approved PMA that is consistent with this part remains in effect.
[51 FR 26364, July 22, 1986, as amended at 79 FR 1740, Jan. 10, 2014]
Notes of Decisions
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).
· cites it 2× “§ 360e(b)(1)(A); 21 CFR § 814.1 (c)(1) (1995). [3] Second, to prevent manufacturers of grandfathered devices from monopolizing the market while new devices clear the PMA hurdle, and to ensure that improvements to existing devices can be rapidly introduced into the market, the…”
Joseph Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017).
“21 C.F.R. § 814.1 . Premarket approyal is a rigorous process of federal review that evaluates a medical device’s safety and effectiveness.”
D'Agostino v. EV3, Inc., 845 F.3d 1 (1st Cir. 2016).
“See 21 C.F.R, § 814.1(c). During that process, the device manufacturer supplies the FDA with extensive information regarding the device — including its design, manufacturing, packing, labeling, and testing — to satisfy the agency that the device is safe and effective.”
Worthy v. Collagen Corp., 967 S.W.2d 360 (Tex. 1998).
· cites it 2× “§ 360e(b)(l)(A); 21 C.F.R. § 814.1 (c)(1) (1997). A second is for devices “substantially equivalent” to devices marketed before May 28, 1976.”
Gomez v. St. Jude Med. Daig Div. Inc., 442 F.3d 919 (5th Cir. 2006).
“§ 360e(b)(1)(A); 21 C.F.R. § 814.1 (c)(1)). Second, devices that are “substantially equivalent” to a preexisting medical device are exempt from the PMA process and instead subject to a streamlined approval process.”
Charlotte Kennedy & Robert L. Kennedy v. Collagen Corp., 67 F.3d 1453 (9th Cir. 1995).
· cites it 2× “§ 360e; 21 C.F.R. § 814.1 (c). In order to attain premarket approval, the manufacturer of a Class III device must submit all of its information on any investigations concerning the device’s safety or effectiveness, a statement of the intended use of the product, a description of…”
Henson v. Dep't of Health & Human Servs., 892 F.3d 868 (7th Cir. 2018).
“He was not satisfied with the response, so he sued, alleging that the agency failed to satisfy its obligations under the Freedom of Information Act.”
Walker v. Johnson & Johnson Vision Prods., Inc, 552 N.W.2d 679 (Mich. Ct. App. 1996).
· cites it 2× “§ 360e; 21 CFR 814.1. The fact that the premarket approval process involves specific requirements, see 21 CFR 814, 820, must not be confused with the premarket approval requirement itself acting as a specific requirement.”
Rosci v. AcroMed, Inc., 669 A.2d 959 (Pa. Super. Ct. 1995).
· cites it 2× “They include Zyderm, as well as pacemakers, heart valves and replacement joints.”
Steele v. Collagen Corp., 97 Cal. Daily Op. Serv. 3683 (Cal. Ct. App. 1997).
· cites it 2× “§ 360e(b)(1)(A); 21 CFR § 814.1 (c)(1). Second, to prevent manufacturers of grandfathered devices from monopolizing the market while new devices clear the PMA hurdle, and to ensure that improvements to existing devices can be rapidly introduced into the market, the Act also…”
— 21 C.F.R. § 814.1(c) — 1 case
D'Agostino v. EV3, Inc., 845 F.3d 1 (1st Cir. 2016).
“See 21 C.F.R, § 814.1(c). During that process, the device manufacturer supplies the FDA with extensive information regarding the device — including its design, manufacturing, packing, labeling, and testing — to satisfy the agency that the device is safe and effective.”
— 21 C.F.R. § 814.1(c)(1) — 2 cases
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