FDA Issues List of Class 1 Accessories
The FDA has finalized a list of accessories that can be classified as Class 1 devices. The listing was required under the FDA Reauthorization Act of 2017.
The agency said it was willing to classify accessories as low-risk as long as they don’t support or sustain life, don’t present an unreasonable risk of injuries or illnesses and if Class 1 general controls assure reasonably low-risk.
The list includes specific accessories for biopsy instruments, stents and catheters, as well as other accessories used in surgery.