Today the Food and Drug Administration (FDA) released a list of 1,003 class II medical devices that it believes do not require premarket notification review. The premarket notification, also known as a 510(k) for its regulation number, is required for medical devices that present enough risk to require such an approval.
The FDA has been attempting to decrease its regulatory burdens and costs to the medical device industry since March. This new development shows a step in the right direction. For a complete list of the devices exempted, see the Federal Register Notice. FDA has also recently identified more than 70 class I devices that are now exempt from 510(k) requirements.
Additionally, the FDA stated that this exemption does not exempt devices from other regulatory controls. Thee controls can include: Current Good Manufacturing Practices, labeling, packaging, establishment registration and listing. All of these are other requirements that are generally necessary to market medical devices in the U.S.
The 510(k) process is daunting and can cost upwards of $70,000 for services and testing. The FDA has now allowed many in the medical device industry avoid this difficult process. Find out if a device you intend to market and sell is exempt. If not, Bustos Law Group can help with the process. Contact us today.