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.
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