The new exemptions may prove to be a relief of regulatory burden that allows manufacturers of affected devices to move forward with business in the United States. 510(k) requirements are often prohibitive for manufacturers; the regulations are extensive and the testing and research required can be expensive.
Manufacturers of devices subject to 510(k) requirements must prove to FDA that the devices are “substantially equivalent” to similar legally marked devices. 510(k) submissions must contain information such as proposed labeling and advertisements, a summary of the technological characteristics of the device, discussion of submitted tests, and much more. There is no 510(k) form or template, but all information must be formatted as described in 21 CFR 807.
Manufacturers of 510(k) exempt devices are still subject to other FDA requirements for medical devices, such as annual registration and listing, UDI requirements, adverse event reporting, labeling requirements, and complying with good manufacturing practices.
