With a few exceptions, it is necessary for manufacturers, system integrators and importers of lasers or laser containing products to implement best practices for compliance with FDA 21 CFR 1040. This is because The Center for Devices and Radiological Health (CDRH) requests documentation using the current version of their Form 3632 Guide for Preparing Product Reports for Lasers or Products Containing Lasers for laser self-certification submittals, which have to comply with…
Posted on May 24, 2017 at 6:31am
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Posted on May 22, 2017 at 7:53am
Both the FDA and the European Medicines Agency (EMA) have regulations that cover the labeling requirements of both prescription and over-the-counter (OTC) drugs, cosmetics, generics, medical devices, nutraceuticals and other related products. These regulations have to be strictly complied with. 21 CFR under its various parts, the Federal Food, Drug, and…
Posted on May 19, 2017 at 6:17am
The knowledge of combination products and their regulations is essential for regulatory professionals. This is because of the high proportion of combination products in the market, as well as the array of regulations that govern them.
21 CFR 3.2 (e) has a complete definition of a combination product. A combination product is one…
Posted on May 17, 2017 at 6:40am