Health Law Advisor

SEPTEMBER 5, 2023

It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is adequate to obtain FDA clearance through the 510(k) process. Indeed, 58% of the results are in that category. Eyes wide open.

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SQA

DECEMBER 16, 2022

ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. The CMDE published additional documents (link in Chinese) that outline the recommended paths for clinical evaluation of certain devices under select sub-categories of the Medical Device Classification Catalog. CMDE Announcement No.

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FDA Compliance COVID-19 Licensing 40

Drug & Device Law

JANUARY 9, 2023

555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. 341, 352 (2001) (“neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles”).

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FDA Governance Nurses 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).

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Informed Consent FDA Doctors 59

Drug & Device Law

JANUARY 30, 2023

341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S.

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FDA Fraud Governance Medicare 72

Drug & Device Law

SEPTEMBER 18, 2023

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” without adversely affecting FDA’s ability to monitor and react to such events.

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FDA Fraud Governance Compliance 59

Drug & Device Law

NOVEMBER 9, 2023

In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here ), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. FDA , 119 F. Caronia , 703 F.3d 3d 149 (2d Cir. 3d 196 (S.D.N.Y.

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FDA Health Insurance Nurses Medicare 64