ProRelix Research

JUNE 26, 2023

As per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, […] The post US FDA Medical Device Applications appeared first on ProRelix Research.

Reagent 52

Reagent In-Vitro Cosmetics Drugs 52

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 ).

In-Vitro 80

In-Vitro Regulation Manufacturing Licensing 80

Roots Analysis

AUGUST 15, 2023

Overview of Cell Free Systems Cell-free systems are ­in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells. In addition to the healthcare industry, other industries, such as food industry, cosmetics industry and enzyme synthesis industry, are also benefiting from the cell free manufacturing process.

Protein 52

Protein In-Vitro Production Reagent 52

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 62

In-Vitro Regulation Production Compliance 62

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

APRIL 19, 2021

We have blogged recently about several FDA setbacks in court ( here , for example). Add one more to that tally. Genus Medical Technologies secured an important victory in the D.C. Circuit Court of Appeals on Friday. In Genus Medical Technologies v. Two judges on the D.C.

Regulation 40

Regulation Production Drugs In-Vitro 40