21 C.F.R. §814.80 - General
| Cite as | 21 C.F.R. §814.80 |
-
- 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
114 cases
-
Haidak v. Collagen Corp., Civ.A. 98-30056-FHF.
...in a manner that is inconsistent with any conditions to approval Page 27 specified in the PMA approval order for the device." 21 C.F.R. § 814.80. In keeping with its legislative purpose, the MDA empowers the FDA to notify the public of risks presented by medical devices, 21 U.S.C. § 360h(a)......
-
Menges v. Depuy Motech, Inc., 3:96 CV 0026 AS.
...being manufactured, packaged, stored, labeled, distributed, or advertised in a manner inconsistent with the conditions of approval. 21 C.F.R. § 814.80. The FDA retains the power to monitor the device and withdraw approval if the device becomes unsafe. 21 U.S.C. §§ 360e(e)(1)-(3) and During ......
-
McLaughlin v. Bayer Corp., CIVIL ACTION NOS. 14-7315
...prohibit a device from being labeled, advertised, or distributed in a manner inconsistent with any condition of approval in the PMA. See21 C.F.R. 814.80 (prohibiting a device from being labeled, advertised, or distributed in a manner inconsistent with any condition of approval in the PMA). ......
-
Mink v. Smith & Nephew, Inc., Case No. 15–CIV–61210–BLOOM/VALLE
...federal law.” See id. at ¶ 51. Mink's strict products liability claim (“Count II”) similarly relies on S & N's purported violation of 21 C.F.R. § 814.80 and other federal regulatory law by deviating from the manufacture specifications approved by the FDA in its PMA Approval Letter. Id. at ¶......
Request a trial to view additional results