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. SaMD products registered with ANVISA will be subject to audis, market monitoring, surveillance, and inspections by the regulator.

FDA 75

FDA Compliance Informed Consent Hospitals 75

SQA

APRIL 30, 2021

In addition, considering the fact that one marketing authorization application is submitted in accordance with Article 8(3) of Directive 2001/83/EC and the other marketing authorization application is submitted under an abridged procedure (e.g.,

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

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. . . Smith & Nephew Richards, Inc. , 2d 35, 41 (D.D.C.

FDA 59

FDA Doctors Malpractice Medical Personnel 59

Drug & Device Law

MAY 30, 2022

2001) (no warning causation notwithstanding heeding presumption where prescriber testified that “the risk of him having a problem due to his [condition] was much greater than him taking the [drug]”) (applying Oklahoma law); Porterfield v. 2001), aff’d , 358 F.3d Stryker Co. , 3d 568, 576-77 (6th Cir. Parke, Davis & Co. ,

Doctors 59

Doctors Licensing Informed Consent Hospitals 59

Drug & Device Law

NOVEMBER 28, 2022

2001) (Kilburn); and Wade-Greaux v. 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. , 1441, 1559-62 (D.V.I. 1994), aff’d mem. , 3d 1120 (3d Cir. 1994) (Gilbert).

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

DECEMBER 9, 2022

And the court agreed, finding that “the undisputed facts reflected that [the doctor] testified she read the IFU, relied on the warnings provided by [the defendant], believed she had a comprehensive informed consent process, and would have passed on a warning about the risk of severe and chronic pain to patients. 2001), aff’d sub nom.

Doctors 64

Doctors Fraud Informed Consent 64

Drug & Device Law

AUGUST 22, 2022

This time, plaintiff pleaded “1) violation of [defendant’s] premarket approval; 2) breach of implied warranty; and 3) lack of informed consent (failure to warn).” Id. 341 (2001). Mentor Worldwide, LLC , 2019 WL 6766574 (M.D. She also tried to sue three new defendants – a doctor, a medical society and the FDA itself.

Informed Consent 59

Informed Consent FDA Doctors 59