Section 803.3 - How does FDA define the terms used in this part?
2 Citing briefs
Moon et al v. Advanced Medical Optics, Inc.
REPLY BRIEF re MOTION for Partial Summary Judgment
Filed April 19, 2010
Case 4:08-cv-00021-HLM Document 191 Filed 04/19/2010 Page 7 of 17 8 cause or contribute to a death or serious injury. 21 C.F.R. § 803.3 (emphasis supplied). From the time CMP was approved by the FDA for sale to the public through 2003, AMO received only 1 report of someone who claimed to have used CMP and developed AK.
Plumbers and Pipefitters Local Union 719 Pension Fund v. Zimmer Holdings, Inc. et al
BRIEF/MEMORANDUM in Support re MOTION for Leave to File Amended Complaint
Filed January 15, 2010
By law, a manufacturer must report an MDR within 30 days after it became aware that a device “may have caused or contributed” to a death or serious injury, or a malfunction that would likely cause or contribute to a death or serious injury. 21 C.F.R. §803.3. Case 1:08-cv-01041-SEB-DML Document 67 Filed 01/15/10 Page 16 of 38 - 11 - 478683_1 ¶125.