On December 30, 2016, FDA-CDRH issued a final guidance document entitled Medical Device Accessories – Describing Accessories and Classification Pathway for new Accessory Types. On January 30, 2017, they updated it to correct “an imprecise statement regarding finished devices”.
In the US, the Food, Drug, and Cosmetics Act, FD&CA, defines a medical device, which includes “any component, part, or accessory”. Consequently, FDA regulates accessories as devices.
Traditionally, FDA classified accessory types in one of two ways:
- Inclusion in the same classification as the parent device
- Issuing a unique, separate classification regulation for the accessory
The guidance document introduces a policy to classify accessories based on two factors:
- Is the article an accessory?
- What are the risks of the accessory when used as intended with the parent device
The guidance document identifies three issues for classification:
- New accessory types may be classified by the de novo process
- Accessory types already classified may seek reclassification
- Accessory types already classified may seek an exemption from 510(k) submission