21 C.F.R. §807.100 - FDA action on a premarket notification

Cite as21 C.F.R. §807.100
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33 cases
  • Burgstahler v. AcroMed Corp.
    • United States
    • Superior Court of Pennsylvania
    • 20 Febrero 1996
    ...... 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 ......
  • Dow v. Baxter Healthcare Corp., Civ. A. No. 94-30099-MAP.
    • United States
    • United States District Courts. 1st Circuit. United States District Courts. 1st Circuit. District of Massachusetts
    • 21 Septiembre 1995
    ...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......
  • Almy v. Sebelius
    • United States
    • United States Courts of Appeals. United States Court of Appeals (4th Circuit)
    • 26 Abril 2012
    ...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......
  • Ginochio v. Surgikos, Inc., C-93-2587-CAL.
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
    • 22 Agosto 1994
    ...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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