SQA

FEBRUARY 15, 2023

Following the draft consultation in November 2022, the NMPA announced the issuance of the Regulations on the Supervision and Management of Enterprises Implementing the Main Responsibility of the Quality and Safety of Medical Devices , which will come into force on 01 March 2023.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Health Law Advisor

OCTOBER 3, 2022

Over the spring and summer, I did a series of posts on extracting quality information from FDA enforcement initiatives like warning letters , recalls , and inspections. But obviously FDA enforcement actions are not the only potential sources of quality data that FDA maintains. Methodology.

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FDA 52

Health Populi

JANUARY 2, 2020

Next week, the Consumer Technology Association (CTA) will convene CES, the Consumer Electronics Show, where over 180,000 tech-minded people from around the world will convene to kick the tires on new TVs, games, smart home devices, 5G connections, 3-D printing, drones, and to be sure, digital health innovations.

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FDA Public Health Telemedicine 124

Drug & Device Law

APRIL 28, 2022

The rules for what federal, state, or local governments can and cannot regulate when it comes to commercial speech by drug and device companies about their products, the conditions they treat, and competitors’ products are not less complex. The Supreme Court decision in Reed v. Town of Gilbert , 576 U.S. Colorado , 530 U.S. at **36-37.

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FDA Governance 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.”

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Informed Consent FDA Doctors 59

Drug & Device Law

JANUARY 30, 2023

The availability of this type of cutting-edge presentations is yet another reason why drug and medical device manufactures would be well served by joining PLAC. For those of you accessing the Blog on mobile devices, this post may be hard to read. So, here are links to both the slide images and the accompanying text.

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FDA Fraud Governance Medicare 72

Drug & Device Law

SEPTEMBER 9, 2022

470 (1996), has nothing useful to say about the FDA’s current system for clearing medical devices. FDA: A Lesson from Pelvic Mesh Litigation on Relative Competence to Decide a Legal Question,” 76 Food & Drug L.J. The device classification process is something Congress took seriously. Lohr , 518 U.S.

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FDA Hospitals 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. Western States Medical Center , 535 U.S. FDA , 119 F.

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FDA Health Insurance Nurses Medicare 64