FDA Unveils Plan for Expedited Device Approvals (ODTMag)
FDA Draft Guidance Document --> Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions
The U.S. Food and Drug Administration (FDA) has unveiled a proposal designed to speed up development and approval of medical devices that treat life-threatening diseases and debilitating conditions.Under the Expedited Access Program, companies developing devices for critical and unmet medical needs would get earlier access to FDA staff to di...
