FDA Exempts Certain Class II Devices from Premarket Notification (510(k))
On July 10, 2017, the U.S. Food and Drug Administration (FDA) announced it is exempting or partially exempting certain class II devices from premarket notification (510(k)) requirements. According to FDA, the newly exempt devices “are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness.”
What is a partially exempt device?
Certain devices are only exempt from 510(k) under the Federal Register if they meet criteria specified by FDA. FDA created new product codes for listed devices that fit these criteria. Listed devices that do not meet the criteria will continue to use the pre-existing product code. The criteria are included in the list. The majority of FDA’s partial exemptions are for products intended for employment and insurance testing.
What does this mean for medical device companies?
The new exemptions may prove to be a relief of regulatory burden that allows manufactures 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. Registrar Corp can assist manufacturers of newly exempt products to comply with FDA’s other regulations.
For questions or assistance with FDA regulations for medical devices, contact Registrar Corp at +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.