FDA Issues Guidance on 510(k) Exemption of Certain Low-Risk Devices

By MedTech Intelligence Staff

The agency’s intent is to decrease regulatory burden while promoting patient access to products.

On Friday FDA issued a guidance on its intent for exemption of certain unclassified, low-risk medical devices from premarket notification requirements. The guidance, “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements”, aims to decrease the regulatory burden as well as reduce compliance costs while still providing patients with access to devices.

“In a commitment letter drafted as part of the reauthorization process for the Medical Device User Fee Amendments of 2012, the FDA committed to identifying low-risk medical devices to exempt from 510(k) requirements. In addition, the 21st Century Cures Act, signed into law on December 13, 2016, granted the FDA authority to exempt from 510(k) requirements Class II and Class I reserved devices the agency believes are sufficiently well understood and no longer warrant 510(k) review prior to allowing the manufacturer to market the device.” – FDA

Devices identified as exempt per the guidance are a small number and include certain:

  • Hearing protectors
  • Aids for speech training for hearing impaired
  • Alcohol disinfectant pads
  • Neurological devices for vibration threshold measurement (not applicable to devices that provide interpretation or clinical implication of the measurement)
  • Monitor for spine curvature
  • Fertility monitors

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