21 C.F.R. §807.100 - FDA action on a premarket notification
| Cite as | 21 C.F.R. §807.100 |
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33 cases
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Burgstahler v. AcroMed Corp.
...... Device Amendments of 1976 ("The MDAs"), 21 U.S.C. §§ 360c et seq. . FACTUAL BACKGROUND . ... physician, on June 23, 1988, and this action was subsequently instituted by appellee. . ... See: 21 U.S.C. § 360c(a)(1)(B); 21 CFR § 860.3(c)(2). Class III devices are those ... III devices are required to obtain premarket approval prior to being released for sale and ... manufacturer must submit a Premarket Notification (PMN), also known as a 510(k) notification, which ......
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Dow v. Baxter Healthcare Corp., Civ. A. No. 94-30099-MAP.
...FDA may request additional information in an effort to determine whether the device is substantially equivalent to a predicate device. 21 C.F.R. § 807.100. The process has been described as Under section 510(k), devices that are shown to be substantially equivalent to a device on the market......
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Almy v. Sebelius
...the predicate device” and the sponsor must “demonstrate[ ] that the device is as safe and as effective as a legally marketed device.” 21 C.F.R. § 807.100(b)(ii)(B). In July 1997, the FDA issued approval under 510(k) for the BIO–1000 to be marketed, finding that it was substantially equivale......
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Ginochio v. Surgikos, Inc., C-93-2587-CAL.
...as a legally marketed device, and (II) does not raise different questions of safety and efficacy than the predicate device. see also 21 C.F.R. § 807.100(b). 5 Defendants cite some regulations which are not general controls but which are discretionary, but do not argue that the FDA has appli......
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