Health Law Advisor

DECEMBER 6, 2022

I thought this month might be an opportunity to show how two different FDA databases produce quite different results when they should be the same. For context, I should explain that I didn’t set out to find differences in the FDA data sets. I don’t know why, and frankly I hope the FDA changes that. Background.

FDA 98

FDA 98

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

OCTOBER 18, 2022

The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada. device identifier “COV-19C25.” that the devices were counterfeit. appears to no longer be manufacturing medical devices.

US Department of Health and Human Services 40

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

Health Law Advisor

MAY 3, 2022

In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter. We have just gone through an extraordinary two years where, in unprecedented fashion, FDA’s inspection process was essentially shut down. Just a short while ago FDA recommenced inspections.

FDA 52

FDA Compliance 52

Drug & Device Law

APRIL 18, 2022

2016), “ Probably the Best Wisconsin Law Decision We’ve Ever Seen.” make clear that Wisconsin adopts the doctrine, as consistently predicted by Wisconsin federal courts since 2016. Teleflex Medical, Inc. We designated the opinion In re Zimmer Nexgen Knee Implant Products Liability Litigation , 218 F. 3d 700 (N.D. Teleflex Med.

FDA 59

FDA 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.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

OCTOBER 7, 2022

This dynamic has not been limited to drugs or drug-device combination products. Contraceptive devices without a pharmacologic action have not avoided litigation. One particular “permanent” implantable contraceptive device has been the subject of litigation for years, even though it was approved by FDA as a class III device. (Our

FDA 59

FDA Fraud Doctors Public Health 59

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.

FDA 59

FDA Hospitals 59