Device Accessories: FDA Drafts List for Reclassification to Class I
Posted 17 August 2018 | By
The US Food and Drug Administration (FDA) on Thursday published a proposed list of medical device accessories that it believes can be reclassified to the agency's lowest risk class, Class I.
The list currently includes accessories that fall under nine distinct product codes, from gastroenterology-urology accessories to a biopsy instrument and ureteral stent accessories.
The agency is also seeking comment from the public on the list, including recommendations for additional accessories that would be suitable for reclassification to Class I and arguments against reclassifying any of the accessories FDA has included on the list.
The move is part of a statutory requirement under the FDA Reauthorization Act of 2017,
which called on the agency to publish such a list within a year of its enactment to allow the agency to focus resources on higher risk products.
"Finalizing the list of accessories suitable for classification into Class I will reduce the regulatory burden for those devices and help support the agency's risk-based approach so that resources can be better focused on the products that pose the most risk to patients," FDA writes.
To be eligible for reclassification into Class I, FDA says the accessories must not be life-supporting or life-sustaining or "of substantial importance in preventing impairment to human health" and do not pose a potential unreasonable risk of illness or injury.
Additionally, only accessories for which general controls alone would be sufficient "to provide a reasonable assurance of safety and effectiveness" were considered.
|Proposed List of Accessories Suitable for Classification into Class I
|Current Classification Regulation (21 CFR)
||Device Type (Product Code)
||Gastroenterology-urology accessories to a biopsy instrument (FCG)
|876.3350 and 876.3630
||Penile implant surgical accessories (JCW and FHW)
||Ureteral stent accessories (FAD)
||Biliary stent, drain and dilator accessories (FGE)
||Suprapubic catheter accessories (KOB)
||Implanted mechanical/hydraulic urinary continence device surgical accessories (EZY)
||Air-handling apparatus accessory (FYD)
|No corresponding CFR Section
||Corneal inlay inserter handle (LQE)