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.
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.,
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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.
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).
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.
Drug & Device Law
JUNE 24, 2022
Plaintiff allegedly suffered an injury that, according to the informed consent form he signed, was a one in 10,000 possibility. 341 (2001). . Vesoulis rejected the plaintiff’s contention that the written consent form he signed did not include a statistical presentation of the risk at issue. at *3 (citation omitted).
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.
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