FDA Releases Modifications to the List of Recognized Standards

May 15, 2014

The FDA has updated its list of recognized standards, restoring recognition to three radiology standards used in premarket reviews of radiology devices. The list is used by devicemakers that opt to declare conformity with consensus standards to meet certain regulatory requirements for their products.

The standards being restored are:

  • IEC 60601-2-33 Edition 3.0 2010-03, Medical electrical equipment—Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis.
  • IEC 60601-2-22 Third edition 2007-05 Medical electrical equipment—Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
  • IEC 60601-1-3 Edition 2.0 2008-01 Medical electrical equipment—Part 1-3: General requirements for basic safety and essential performance – Collateral standard: radiation protection in diagnostic x-ray equipment.

Thursday’s Federal Register notice says recognition will be restored “with transition period,” but does not specify a timeline.  Requests to the FDA for additional information were not returned by press time.

Read the full notice here. — Kellen Owings

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