USA – FDA Reclassifies Certain Device Accessories to Class I

The US Food and Drug Administration (FDA) on Thursday published a final classification action that would reclassify eight types of medical device accessories to class I.

The decision to reclassify the accessories — the final list is the same as the proposed list — is part of what’s required by the FDA Reauthorization Act of 2017, which also reauthorized the user fee programs.

The final classification action will be effective on 13 May, and the complete list of accessories includes:

  • Gastroenterology-urology accessories to a biopsy instrument
  • Penile implant surgical accessories
  • Ureteral stent accessories
  • Biliary stent, drain and dilator accessories
  • Suprapubic catheter accessories
  • Implanted mechanical/hydraulic urinary continence device surgical accessories
  • Air-handling apparatus accessory
  • Corneal inlay inserter handle

In response to comments suggesting additional products be classified into class I, FDA said: “We have reviewed all product codes suggested for distinct classification into class I in response to comments and have determined that additional product codes identified are not appropriate for this list at the present time for one or more of the following reasons: (1) the accessory type is already distinctly classified; (2) the accessory is of a type that is already class I; or (3) insufficient information was provided to demonstrate that general controls alone will provide reasonable assurance of safety and effectiveness.”…