(a) Identification. A replacement heart valve is a device intended to perform the function of any of the heart's natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of prosthetic and biologic materials.
(b) Classification. Class III (premarket approval).
(c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 9, 1987 for any replacement heart valve that was in commercial distribution before May 28, 1976, or that has on or before December 9, 1987 been found to be substantially equivalent to a replacement heart valve that was in commercial distribution before May 28, 1976. Any other replacement heart valve shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 18163, May 13, 1987; 52 FR 23137, June 17, 1987]
Notes of Decisions
Bravman v. Baxter Healthcare Corp., 842 F. Supp. 747 (S.D.N.Y. 1994).
· cites it 2× “An “identification provision” in the federal regulations does not act as a specific requirement which would preempt state common law.”
Blanco v. Baxter Healthcare Corp., 64 U.C.C. Rep. Serv. 2d (West) 790 (Cal. Ct. App. 2008).
“( 21 C.F.R. § 870.3925 (b) (2007).) Subject to two statutory exceptions not relevant here, 2 class III devices must receive premarket approval through the PMA process “to provide reasonable assurance of [its] safety and effectiveness .”
Kemp v. Pfizer, Inc., 835 F. Supp. 1015 (E.D. Mich. 1993).
“The defendants’ C/C valve is covered by the MDA under 21 C.F.R. § 870.3925 . At the time that the valve was implanted into Mr.”
Ministry of Health v. Shiley Inc., 858 F. Supp. 1426 (C.D. Cal. 1994).
“Federal and FDA Regulations of Class III Devices, including Heart Valves Under 21 C.F.R. § 870.3925 , written by the agency charged with implementing the legislation, artificial heart valves are Class III medical devices.”
Nw. Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993).
“21 C.F.R. § 870.3925 . A second regulation promulgated in 1987 subjects replacement heart valves to premarket approval.”
Alabama Tissue Ctr. of Univ. of Alabama Health Serv. Found. v. Sullivan, 975 F.2d 373 (7th Cir. 1992).
· cites it 3× “21 C.F.R. § 870.3925 (a). The FDA then issued a proposed regulation in 1986 requiring (i) the filing of a PMA or a product development protocol (“PDP”) for preamendment replacement heart valves and their equivalents; and (ii) an approved PMA or a declared and completed PDP for…”
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