Compliance Cosmetics Development In-Vitro 
pharmaphorum
SEPTEMBER 29, 2022
Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. If so, developers must develop and execute on a regulatory strategy. The FDA’s General Approach to Regulating mHealth Products.
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.
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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.
FDA Law Blog
DECEMBER 6, 2023
filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. As a threshold matter, FDA lacks the power to regulate tests developed and used in a laboratory. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.
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
OCTOBER 6, 2023
Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). There is much to unpack, and we intend to do so in a series of blog posts. In this post, we focus on the proposed changes themselves, and the many questions the agency leaves unanswered.
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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