Apr 15, 2019
EMERGO BY UL SUMMARY OF KEY POINTS:
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.
FDA identified Class I classification criteria for accessories based on the following requirements:
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.
EMERGO BY UL SUMMARY OF KEY POINTS:
EMERGO BY UL SUMMARY OF KEY POINTS:
EMERGO BY UL SUMMARY OF KEY POINTS: