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United States Issues Finalized List of Accessories Applicable to Class I Medical Devices


The US Food and Drug Administration (FDA) determined the list of accessories suitable for Class I Medical Devices. This classification came into force on May 13, 2019. The Classification was carried out according to the risks of the accessory's intended application and the level of regulatory controls that require to provide a reasonable assurance of safety and effectiveness of the accessory.

The final list of accessories includes the following:

  • Gastroenterology-urology accessories to biopsy instruments

  • Penile implant surgical accessories

  • Urethral stent accessories

  • Biliary stent, drain, and dilator accessories

  • Suprapubic catheter accessories

  • Implanted mechanical/hydraulic urinary continence device surgical accessories

  • Air-handling apparatus accessories

  • Corneal inlay inserter handles

The following principles were used to determine whether the accessory can be classified as a Class I product when it is different from another device:

1. The accessory is not used for supporting or sustaining a human life or of substantial importance in preventing impairment to the human health

2. The accessory does not represent a potential unreasonable risk of illness or injury

3. General controls alone would be sufficient to provide a reasonable assurance of safety and effectiveness of the accessory.

Please, note that within five years the FDA plans to propose additional medical device accessories appropriate for Class I designation.

The information has been prepared by the GMA Consult Group team.

GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side.

Need your own guide to the world of certification and approvals? Don't hesitate to contact us via info@gma.trade.

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