21 CFR 807.97 - Misbranding by reference to premarket notification
| Cite as | 21 CFR 807.97 |
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181 practice notes
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Mears v. Marshall
...of the device's safety and effectiveness." HRRep No 101-808, 101st Cong 2d Sess 14 (1990), reprinted in 1990 USCCAN 6305, 6307; see also 21 CFR § 807.97 (determination that device is "substantially equivalent" does not in any way denote official approval by the FDA). Plaintiff inappropriate......
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Fogal v. Steinfeld
...the FDA that the device is substantially equivalent to a pre-MDA device "does not in any way denote official approval of the device." (21 C.F.R. § 807.97) In 1990 Congress passed the Safe Medical Devices Act, Pub.L. 101-629, 104 U.S.Stat. 4511, to correct various perceived difficulties in t......
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United States ex rel. Nowak v. Medtronic, Inc., Civil Action Nos. 1:08–cv–10368
...cleared use of the device to those indications listed in the application as the intended uses. 21 U.S.C. § 352(f); 21 C.F.R. § 801.5; 21 C.F.R. § 807.97. These limited indications must be listed on the label, and a manufacturer may only promote a device for cleared or approved indications. ......
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Almy v. Sebelius, Civil Action No. RDB–08–1245.
...(9th Cir.2010) (“[u]nlike premarket approval, 510(k) clearance ‘does not in any way denote official approval of the device’ ”) (quoting 21 C.F.R. § 807.97). FDA clearance or approval—particularly of the form provided under § 510(k)—does not automatically guarantee Medicare coverage, as the ......
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179 cases
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Mears v. Marshall
...device's safety and effectiveness." HRRep No 101-808, 101st Cong 2d Sess 14 (1990), reprinted in 1990 USCCAN 6305, 6307; see also 21 CFR § 807.97 (determination that device is "substantially equivalent" does not in any way denote official approval by the FDA). Plaintiff inapp......
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Riegel v. Medtronic, Inc., Docket No. 04-0412-CV.
...approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding." 21 C.F.R. § 807.97 (emphasis Once a device has entered the market pursuant to the § 510(k) process, its manufacturer has broader latitude to make changes on......
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Fogal v. Steinfeld
...the device is substantially equivalent to a pre-MDA device "does not in any way denote official approval of the device." (21 C.F.R. § 807.97) In 1990 Congress passed the Safe Medical Devices Act, Pub.L. 101-629, 104 U.S.Stat. 4511, to correct various perceived difficulties in the ......
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United States ex rel. Nowak v. Medtronic, Inc., Civil Action Nos. 1:08–cv–10368
...cleared use of the device to those indications listed in the application as the intended uses. 21 U.S.C. § 352(f); 21 C.F.R. § 801.5; 21 C.F.R. § 807.97. These limited indications must be listed on the label, and a manufacturer may only promote a device for cleared or approved indications. ......
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2 firm's commentaries
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Guest Post − No One Should Ever Rely on What Lohr Says about FDA Device Clearance
...510(k) is inferior to approval of a riskier Class III device because a regulation precludes describing 510(k) clearance as “approval.” 21 C.F.R. §807.97. The FDA adopted that regulation in 1976, when all clearance was transitional, and required only the filing of the previously described 51......
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Guest Post − No One Should Ever Rely on What Lohr Says about FDA Device Clearance
...510(k) is inferior to approval of a riskier Class III device because a regulation precludes describing 510(k) clearance as “approval.” 21 C.F.R. §807.97. The FDA adopted that regulation in 1976, when all clearance was transitional, and required only the filing of the previously described 51......