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Medical Devices-USA/Europe Regulatory News-October 2023

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  • Premarket Notification (510(k)) submissions
  • De Novo requests;
  • Premarket Approval Applications (PMAs) and PMA supplements;
  • Product Development Protocols (PDPs);
  • Investigational Device Exemption (IDE) submissions;
  • Humanitarian Device Exemption (HDE) submissions;
  • Biologics License Application (BLA) submissions; and
  • Investigational New Drug (IND) submissions.
  • Apply for an MDEL
  • Submit an annual license review before April 1 of each year
  • Make change(s) to your existing license (for example, an amendment or section 48 notification)
  • Cancel your MDEL
  • Reinstate your license after a suspension

EUROPE

The Innovative Devices Access Pathway (IDAP) (Published on 19 September, 2023)

https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap

https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap/the-innovative-devices-access-pathway-idap-pilot-phase