21 CFR 807.100 - FDA action on a premarket notification

Cite as21 CFR 807.100
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41 practice notes
  • Burgstahler v. AcroMed Corp.
    • United States
    • Superior Court of Pennsylvania
    • February 20, 1996
    ...90 days before marketing a device. The FDA must then clear the device for marketing. 21 U.S.C. § 360(k); 21 C.F.R. §§ 807.87, 807.90, 807.100; Duvall v. Bristol-Myers-Squibb Co., 65 F.3d 392, 396 (4th The Pre-Market Notification process requires applicants to submit descriptions of their de......
  • 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
    • September 21, 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, No. 10–2241.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (4th Circuit)
    • April 26, 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., No. C-93-2587-CAL.
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
    • August 22, 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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33 cases
  • Burgstahler v. AcroMed Corp.
    • United States
    • Superior Court of Pennsylvania
    • February 20, 1996
    ...90 days before marketing a device. The FDA must then clear the device for marketing. 21 U.S.C. § 360(k); 21 C.F.R. §§ 807.87, 807.90, 807.100; Duvall v. Bristol-Myers-Squibb Co., 65 F.3d 392, 396 (4th The Pre-Market Notification process requires applicants to submit descriptions of their de......
  • 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
    • September 21, 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, No. 10–2241.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (4th Circuit)
    • April 26, 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., No. C-93-2587-CAL.
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
    • August 22, 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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8 firm's commentaries
  • FDA Device Clearance – Clearly Relevant
    • United States
    • LexBlog United States
    • July 5, 2013
    ...a legally marketed device” and “does not raise different questions of safety and effectiveness.” 21 U.S.C. §360c(i)(1)(A). See also 21 C.F.R. §807.100(B)(2)(ii) (regulation paralleling the statute). According to the FDA, these statutory changes mean that §510(k) is now explicitly concerned ......
  • Implied Preemption And Medical Devices
    • United States
    • JD Supra United States
    • July 13, 2011
    ...as a legally marketed device; and (C) Does not raise different questions of safety and effectiveness than the predicate device.” 21 C.F.R. §807.100 (emphasis added). There are undoubtedly Guidance Documents, device-specific clearance letters, and other FDA materials that give flesh to the s......
  • Is Your Smart Phone An FDA-Regulated Medical Device?
    • United States
    • Mondaq United States
    • August 9, 2011
    ...21 C.F.R. Chapter 1, Subchapter H. Many devices cannot be marketed without prior permission from the FDA. FD&C Act, § 510(k); 21 C.F.R. § 807.100(a). Novel or potentially dangerous devices may be subject to a rigorous premarket approval process requiring expensive and time-consuming cli......
  • Is Your Smart Phone An FDA-Regulated Medical Device? - FDA Announces Plans To Regulate 'Mobile Medical Applications'
    • United States
    • Mondaq United States
    • August 9, 2011
    ...21 C.F.R. Chapter 1, Subchapter H. Many devices cannot be marketed without prior permission from the FDA. FD&C Act, § 510(k); 21 C.F.R. § 807.100(a). Novel or potentially dangerous devices may be subject to a rigorous premarket approval process requiring expensive and time-consuming cli......
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