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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.

Learn more about US FDA medical device regulations at Emergo by UL:

  • FDA 510(k) consulting for medical device companies
  • FDA medical device classification consulting
  • Whitepaper: Preparing a US FDA 510(k) submission
  • Whitepaper: Navigating the US FDA medical device classification system

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