21 CFR 814.2 - Purpose
| Cite as | 21 CFR 814.2 |
-
- This document is available in original version only for vLex customers
View this document and try vLex for 7 days - TRY VLEX
- This document is available in original version only for vLex customers
8 practice notes
-
United States ex rel. Modglin v. Djo Global Inc., Case No. CV 12–07152 MMM (JCGx).
...PMA application contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use. 21 C.F.R. § 814.2(a). It is “a ‘rigorous' process in which the manufacturer submits to the FDA extensive study reports, design specifications and descriptions,......
-
United States ex rel. Modglin v. DJO Global Inc., Case No. CV 12–07152 MMM (JCGx).
...PMA application contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use. 21 C.F.R. § 814.2(a). It is "a ‘rigorous' process in which the manufacturer submits extensive study reports, design specifications and descriptions, samples of......
-
United States ex rel. Modglin v. DJO Global Inc., Case No. CV 12–07152 MMM JCGx.
...PMA application contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use. 21 C.F.R. § 814.2(a). It is “a ‘rigorous' process in which the manufacturer submits to the FDA extensive study reports, design specifications and descriptions,......
-
Worthy v. Collagen Corp., 96-0675
...for those devices 'that have been shown to be safe and effective and that otherwise meet the statutory criteria for approval.' 21 C.F.R. § 814.2(a)."); Steele v. Collagen Corp., 54 Cal.App.4th 1474, 63 Cal.Rptr.2d 879, 882 (1997) ("Most courts that have dealt with the issue of MDA preemptio......
Request a trial to view additional results
7 cases
-
United States ex rel. Modglin v. DJO Global Inc., Case No. CV 12–07152 MMM JCGx.
...PMA application contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use. 21 C.F.R. § 814.2(a). It is “a ‘rigorous' process in which the manufacturer submits to the FDA extensive study reports, design specifications and descriptions,......
-
United States ex rel. Modglin v. DJO Global Inc., Case No. CV 12–07152 MMM (JCGx).
...PMA application contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use. 21 C.F.R. § 814.2(a). It is "a ‘rigorous' process in which the manufacturer submits extensive study reports, design specifications and descriptions, samples of......
-
Worthy v. Collagen Corp., No. 96-0675
...for those devices 'that have been shown to be safe and effective and that otherwise meet the statutory criteria for approval.' 21 C.F.R. § 814.2(a)."); Steele v. Collagen Corp., 54 Cal.App.4th 1474, 63 Cal.Rptr.2d 879, 882 (1997) ("Most courts that have dealt with the issue of MDA preemptio......
-
United States ex rel. Modglin v. Djo Global Inc., Case No. CV 12–07152 MMM (JCGx).
...PMA application contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use. 21 C.F.R. § 814.2(a). It is “a ‘rigorous' process in which the manufacturer submits to the FDA extensive study reports, design specifications and descriptions,......
Request a trial to view additional results