2015 Individual Manufacturing Medical 
FDA Law
NOVEMBER 1, 2023
Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.
FDA Law
FEBRUARY 21, 2024
By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. The final rule emphasizes risk management activities and risk-based decision making.
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FDA Law
MARCH 8, 2023
By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.
FDA Law
DECEMBER 18, 2022
Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. The VMSR Program allows manufacturers to bundle malfunction reports of “like events” together in a single summary report. FDA began an initial VMSR pilot program in 2015.
GeriPal
MARCH 2, 2023
By 2015 that number increased to 4% of US adults. It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. I also heard that if you look at all individuals in the US, about 4% of individuals are taking one of the gabapentinoids, 10% over 65.
FDA Law
AUGUST 21, 2023
Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Interestingly, the Plaintiffs alleged that this duty existed when the mother was pregnant in 2015 even though the studies relied upon in the litigation are from 2021.
GeriPal
DECEMBER 7, 2023
was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. And we have gone from 250 members at the end of 2015 to about 26,000 right now across the United States and a number of chapters that have grown. And then for medical education, I know they are doing a lot as well.
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