Government Manufacturing Medical Presentation 
FDA Law
JUNE 22, 2025
By JP Ellison — Last Friday, the Supreme Court delivered a trio of decisions making it easier to litigate against the federal government. That said, it’s hard to see how the score on Friday wasn’t 3 for regulated industry and 0 for the federal government. Reynolds Vapor Co. , Finally, in McLaughlin Chiropractic Associates, Inc.
FDA Law
JANUARY 18, 2022
Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. Rather, it is meant to present various scenarios related to use of 3D?printed
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FDA Law
JANUARY 18, 2022
Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. Rather, it is meant to present various scenarios related to use of 3D?printed
FDA Law
MARCH 3, 2024
This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act? House of Representatives ( H.B.
FDA Law
OCTOBER 25, 2021
The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. befitted a very important pathway to market for novel medical devices. FDCA § 513(f)(5).
FDA Law
MARCH 20, 2022
Baumhardt, Senior Medical Device Regulation Expert & Anne K. Almost all recalls are conducted on a voluntary basis by the manufacturer. Most FDA-regulated entities have an established SOP that governs the evaluation, decision, notification, and process for conducting a recall. By Philip Won & Lisa M.
FDA Law
AUGUST 17, 2022
We note, however, that some of the most important clarifications are not codified in the actual rule but are presented in the Preamble; thus, while FDA currently plans to interpret the rule as it states in the Preamble, it is not bound to do so. FYI, FDA does not use the term “regular hearing aids,” but we are for simplicity.)
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