21 CFR 814.1 - Scope
| Cite as | 21 CFR 814.1 |
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50 practice notes
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Blanco v. Baxter Healthcare Corp., No. G038255.
...the PMA process "to provide reasonable assurance of [its] safety and effectiveness...." (21 U.S.C. §§ 360c(a)(l)(C), 360e(d)(2); 21 C.F.R. § 814.1 et The MDA requires the PMA application to contain the following information: full reports on investigations concerning whether the device is sa......
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Fogal v. Steinfeld
...under 21 U.S.C. § 360e(b) requiring the device to have an approved premarket approval application. [21 U.S.C. § 360c(f)(3); 21 C.F.R. § 814.1(c) ] Such an exemption is obtained by submitting a premarket notification or "510(k)" 2 application to the FDA 90 days before the manufacturer propos......
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In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Prods. Liab. Litig., MDL No. 2775
...and completes the requisite PMA." Lohr , 518 U.S. at 478, 116 S.Ct. 2240 (first citing 21 U.S.C. § 360e(b)(1)(A), and then citing 21 C.F.R. § 814.1(c)(1) (1995) ). "Second, to prevent manufacturers of grandfathered devices from monopolizing the market while new devices clear the PMA hurdle,......
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Worthy v. Collagen Corp., No. 96-0675
...spending an average of 1,200 hours on each submission." Medtronic, 518 U.S. at 477, 116 S.Ct. at 2246-2247; see 21 U.S.C. § 360e(c); 21 C.F.R. 814.1-.126 Specifically, a PMA application must contain: (A) full reports of all information, published or known to or which should reasonably be kn......
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49 cases
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Blanco v. Baxter Healthcare Corp., G038255.
...the PMA process "to provide reasonable assurance of [its] safety and effectiveness...." (21 U.S.C. §§ 360c(a)(l)(C), 360e(d)(2); 21 C.F.R. § 814.1 et The MDA requires the PMA application to contain the following information: full reports on investigations concerning whether the device is sa......
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Fogal v. Steinfeld
...under 21 U.S.C. § 360e(b) requiring the device to have an approved premarket approval application. [21 U.S.C. § 360c(f)(3); 21 C.F.R. § 814.1(c) ] Such an exemption is obtained by submitting a premarket notification or "510(k)" 2 application to the FDA 90 days before the manufacturer propos......
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In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Prods. Liab. Litig., MDL No. 2775
...and completes the requisite PMA." Lohr , 518 U.S. at 478, 116 S.Ct. 2240 (first citing 21 U.S.C. § 360e(b)(1)(A), and then citing 21 C.F.R. § 814.1(c)(1) (1995) ). "Second, to prevent manufacturers of grandfathered devices from monopolizing the market while new devices clear the PMA hurdle,......
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Worthy v. Collagen Corp., 96-0675
...spending an average of 1,200 hours on each submission." Medtronic, 518 U.S. at 477, 116 S.Ct. at 2246-2247; see 21 U.S.C. § 360e(c); 21 C.F.R. 814.1-.126 Specifically, a PMA application must contain: (A) full reports of all information, published or known to or which should reasonably be kn......
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1 firm's commentaries
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FDA Issues Final Guidance On Refuse To Accept Policy For 510(K)S And PMAS
...PMA if the Applicant has a 510(k) pending for same device, and the FDA has not determined whether the device falls within the scope of 21 C.F.R. § 814.1(c). A PMA will not be accepted if it contains a false statement of material fact or is not accompanied by a statement of either certificat......