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.,

Medical 98

Medical Manufacturing Healthcare Government 98

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.,

Medical 75

Medical Manufacturing Healthcare Government 75

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.

IT 52

IT Manufacturing Education Provider 52

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.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64