pharmaphorum

SEPTEMBER 29, 2022

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. When assessing mHealth technology, the FDA will determine whether an application is either: i.

Development 104

Development Regulation Production Life Science 104

FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software.

In-Vitro 81

In-Vitro Regulation Manufacturing Licensing 81

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.

In-Vitro 64

In-Vitro Regulation Production Compliance 64

FDA Law Blog

AUGUST 3, 2022

If anything, the announcement was remarkably inconspicuous: a seemingly throwaway sentence in a draft compliance policy guide for research use only and investigational use only products. These products are subject to the same regulatory requirements as any unapproved medical device”).

In-Vitro 98

In-Vitro Regulation Production Compliance 98

FDA Law Blog

FEBRUARY 23, 2025

By Steven J. Gonzalez & Allyson B. Mullen As the device industry is well aware, one of the greyest areas in device regulation (of which there are many) is determining when changes to a 510(k)-cleared device trigger the need for a new clearance. See 21 C.F.R. But this guidance has its limitations.

Manufacturing 64

Manufacturing In-Vitro Reagent Production 64