FDA Law
JANUARY 18, 2022
In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” use in education, construction, art, and jewelry). FDA does regulate 3D printing equipment and activities when intended to produce regulated medical devices (i.e.,
FDA Law
JANUARY 18, 2022
In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” use in education, construction, art, and jewelry). FDA does regulate 3D printing equipment and activities when intended to produce regulated medical devices (i.e.,
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FDA Law
AUGUST 23, 2021
Kirschenbaum — On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of a revised PhRMA Code on Interactions with Health Care Professionals , which takes effect on January 1, 2022. Department of Health and Human Services (OIG) (see our blog post on this Special Fraud Alert here ).
FDA Law
SEPTEMBER 22, 2024
See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. issues with the design, manufacturing, and components of the device).
FDA Law
DECEMBER 20, 2021
Specifically, the issue is whether this provision applies to bar dietary supplements, such as NAC, that were on the market before the enactment of the Dietary Supplement Health Education Act (DSHEA), in 1994, which added this exclusionary clause into the FDC Act. FDA merely indicated that it was still considering that issue.
FDA Law
JANUARY 26, 2022
By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! These are the “pivot” situations, where it is helpful to clearly distinguish disease education from product promotion.
FDA Law
JULY 7, 2024
Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.
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