Compliance Cosmetics In-Vitro Marketing 
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. In the pre-market area, Ms. In the post-market area, Ms. Prior to joining the Firm, Ms. In addition, Ms.
pharmaphorum
OCTOBER 27, 2022
To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. What is the scope of the Guidance? Companies can sponsor website content if the role of the company is made clear.
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FDA Law Blog
DECEMBER 6, 2023
We’ve previously written about this proposed rule (see here , here , and here ) which would transform the diagnostic market in the United States. 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.
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.
pharmaphorum
OCTOBER 4, 2022
The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) were considered. Part 2 of this series is devoted to clinical decision support (CDS) software.
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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