US FDA issues finalized list of Class I medical device accessories
Regulatory Updates | Medical Devices
EMERGO BY UL SUMMARY OF KEY POINTS:
- FDA finalizes Class I classification for some medical device accessories;
- Class I designations take effect May 13, 2019;
- Additional accessories may be identified for low-risk classification by 2024.
The US Food and Drug Administration has published 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’s final rule will go into effect May 13, 2019.
Class I eligibility criteria for medical device accessories
FDA identified Class I classification criteria for accessories based on the following requirements:
- The accessory is not used to support or sustain human life, or is important in prevention of impairment to health;
- The accessory does not pose a potential risk of illness or injury;
- General controls can sufficiently provide reasonable assurance of the accessory’s safety and effectiveness.
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.