Drafting Healthcare Manufacturing 
JURIST
APRIL 27, 2023
The EU Wednesday released a draft of its proposed overhaul of drug manufacturing laws. The changes have caused controversy among manufacturers, with some stating they will leave the region if the laws take effect. However, the changes sparked some pushback from the drug manufacturing industry.
FDA Law Blog
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.” The first scenario is a healthcare facility using a medical device 3D-printing production system. use in education, construction, art, and jewelry).
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FDA Law Blog
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.” The first scenario is a healthcare facility using a medical device 3D-printing production system. use in education, construction, art, and jewelry).
FDA Law Blog
NOVEMBER 29, 2023
Since that time, FDA issued a draft guidance for predetermined change control plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML) software functions. Transparency This guiding principle calls for manufacturers to be transparent with users regarding the device performance before and after the implementation of the change.
FDA Law Blog
DECEMBER 12, 2022
Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The draft guidance purports to apply to current PMA holders. Draft Guidance. By Jeffrey K.
FDA Law Blog
SEPTEMBER 15, 2022
For both draft guidances, it is unclear what induced FDA to publish these draft guidances now. Draft Guidance Regarding the Statement of Identity and Strength for Human Nonprescription Drug Products. For both guidances, comments must be submitted by November 8, 2022, to be considered by FDA.
FDA Law Blog
OCTOBER 10, 2023
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”
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