Oct 22, 2018

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has updated its list of Recognized Consensus Standards for use in medical device premarket submissions.
  • FDA’s latest round of modifications and additions to the list cover orthopedic, materials, IVD and other medical device areas.

The US Food and Drug Administration’s latest changes and additions to its list of Recognized Consensus Standards for medical devices affect primarily orthopedic, IVD and materials areas as well as several other device categories.

FDA’s new list of modifications and changes to medical device consensus standards include withdrawals, revisions and replacements of existing standards used in 510(k) and other premarket review processes, as well as new entries to the recognized standards list.

Among modified standards on FDA’s updated list, 19 standards have been changed under the orthopedics category, followed by 16 under Materials, 10 under IVDs and seven under Sterility.

Among new standards added to the list, six pertain to orthopedics, five to dental and ear, nose and throat devices, and four to cardiovascular devices.

Related US FDA medical device and IVD regulatory information:

  • US FDA 510(k) medical device and IVD registration consulting
  • FDA medical device classification consulting
  • ISO 14971 risk management consulting for medical devices
  • ISO 17664 medical device sterilization and cleaning validation
  • Whitepaper: Medical device labeling, standards and symbols