Rx REPORT

FDA Issues Final Guidance on Medical Device Accessories

On Friday, December 30, 2016, FDA issued final guidance is intended to provide guidance to industry and FDA staff about the regulation of accessories to medical devices.

Accordingly, this guidance describes the types of devices that FDA generally considers as accessories and discusses the risk- and regulatory control-based classification paradigm for these accessories.

This information is expected to provide a greater level of transparency with regards to the classification of accessories and will aid FDA staff and industry in assuring that these devices are subject to an appropriate level of regulatory oversight by FDA.

In addition, this guidance describes the use of the de novo classification process under section 513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)) for manufacturers to request risk- and regulatory control-based classifications of accessories of a new type that are low-moderate risk for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.

FDA will also be holding a webinar on February 2, 2017 to share information and answer questions about the final guidance document.  Information on the webinar can be found here.

Click here to access the final FDA guidance.