The FDA has developed a draft document to provide guidance to industry and FDA staff about the regulation of accessories to medical devices. This guidance is intended to clarify and modify the FDA’s policy concerning the classification of accessories and to discuss the application of that policy to specific categories of devices that are commonly used as accessories to other medical devices.
This guidance document clarifies what FDA intends to consider an “accessory” and clarifies how FDA’s risk-based framework for classification applies to accessories to other medical devices. The considerations for determining applicable risk apply to all accessories.
Comments regarding this guidance document may be submitted for up to 90 days. Submit electronic comments to http://www.regulations.gov.