SQA

MAY 17, 2022

Requirements for classification and related issues established under RDC 185/2001, as well as other relevant medical device regulations, will apply for SaMD, as well. United States Food and Drug Administration (FDA) – Regulations and Guidances. Additional details for each annex are provided within the content section of the document.

FDA 75

FDA Compliance Informed Consent Hospitals 75

Drug & Device Law

JUNE 6, 2022

Because we encountered many stand up learned intermediary surgeons in the Bone Screw litigation, several of the relatively early decisions from the 1999-2001 timeframe are Bone Screw cases. 2001) (no causation where medical personnel “had no alternative other than to use the. . . Bayer HealthCare Pharmaceuticals, Inc. ,

FDA 59

FDA Doctors Malpractice Informed Consent 59

Drug & Device Law

NOVEMBER 28, 2022

2001) (Kilburn); and Wade-Greaux v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). I-Flow Corp. , 2d 1092, 1119-25 (D. 2010) (Matsen); Nelson v. Tennessee Gas Pipeline Co. 1998 WL 1297690, at *4, 7-8 (W.D. 31, 1998), aff’d , 243 F.3d 3d 244 (6th Cir. Whitehall Laboratories, Inc. ,

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

AUGUST 22, 2022

The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. First, the plaintiff’s non-parallel claims were “preempted to the extent” that they would have imposed “alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA.” 341 (2001).

Informed Consent 59

Informed Consent FDA Doctors 59