Healthcare, Industry News, Medical Devices, Regulatory Affairs

FDA finalizes Class I classification for some medical device accessories

The US Food and Drug Administration has published a final rule that will go into effect from May 13, 2019, it includes a finalized list of accessories to be designated as low-risk Class I medical devices in accordance with the FDA Reauthorization Act of 2017 (FDARA).

FDA have considered an accessory to be eligible for classification into class I distinct from another device if the accessory based on the following requirements:

  • The accessory is not for use in supporting or sustaining human life, or of substantial importance in preventing impairment to human health;
  • The accessory does not represent a potential unreasonable risk of illness or injury; and
  • If general controls alone would be sufficient to provide a reasonable assurance of safety and effectiveness of the accessory.

The list of accessories to fall under Class I classification includes gastroenterology-urology accessories; ureteral stent accessories; implanted mechanical and hydraulic urinary continence device surgical accessories; air-handling apparatus accessories; and corneal inlay inserter handles.

Within five years, FDA plans to propose additional medical device accessories appropriate for Class I designation.

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