The Food and Drug Administration (FDA) is inviting public comments on a proposed collection of information concerning device classification and regulatory requirements, as part of their responsibilities under the Paperwork Reduction Act of 1995. The information collection supports regulations and guidance under section 513(g) of the Federal Food, Drug, and Cosmetic Act, which outlines how people can request the FDA's views on device classification and applicable requirements. Individuals can submit comments electronically or by mail by March 15, 2021. Comments should focus on the necessity, accuracy, and potential improvements of the proposed information collection process.
Simple Explanation
The FDA wants to know what people think about some new rules they are making for anyone who wants to ask them about their gadgets and how they should be classified. People can tell the FDA what they think by sending comments before March 15, 2021.