Compliance Cosmetics Drugs In-Vitro 
FDA Law Blog
NOVEMBER 16, 2021
Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics. Baumhardt advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters. In the pre-market area, Ms. In addition, Ms.
pharmaphorum
SEPTEMBER 29, 2022
Food and Drug Administration (FDA) regulation as a medical device. In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products.
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FDA Law Blog
DECEMBER 6, 2023
The Federal Food, Drug, and Cosmetic Act simply did not confer that power upon FDA. The PRIA also omits entire other categories of costs, such compliance with 21 C.F.R. Javitt — On Monday, Hyman, Phelps & McNamara, P.C. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation.
pharmaphorum
OCTOBER 4, 2022
On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criterion 1. Criterion 2.
FDA Law Blog
OCTOBER 6, 2023
The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. There is much to unpack, and we intend to do so in a series of blog posts.
FDA Law Blog
FEBRUARY 4, 2024
Medical Device Reporting, Quality System Regulation compliance, and reporting of corrections and removals). The joint press release largely repeats, and has CMS endorse, the arguments FDA has previously made in support of its proposed rule, which we rebut in the detailed comments we filed on behalf of a coalition of laboratories.
FDA Law Blog
NOVEMBER 1, 2023
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 ).
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