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Archive for month: November, 2017


New FDA Breakthrough Medical Devices Programme

The FDA has released draft guidance for its new Breakthrough Medical Device Programme which will replace the current priority review programs including the Expedited Access Pathway (EAP) and the Priority Review Program.

Features included in the new guidance:

  • Review of product which could lead to jumping the queue
  • More interactive communications
  • Post Market data collection in lieu of Pre Market data collection
  • Ease sponsors’ clinical study design obligations
  • Support from FDA review teams
  • Expedited review of manufacturing sites
  • Impacts 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE) and de novo applications.

For more information or a discussion with our experts on how this impacts your medical device products please reach out to Instem and the Samarind RMS team on [email protected] or call the team on +44 1244 287 900.

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