The FDA Releases New Guidance Document to Strengthen Cybersecurity of Medical Devices

The US FDA has released a final guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices to strengthen the safety of medical devices.

Although medical devices have the ability to improve patient care and create efficiencies in the healthcare system as they become more interconnected and interoperable, risks for Continue reading

Expedited Access for Premarket Approval (EAP) Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions – Draft Guidance

FDA Draft Guidance: Expedited Access for Premarket Approval (EAP) Medical Devices On April 23, 2014 the FDA released for comment purposes only, the Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions – Draft Guidance for Industry. Comments should be received by the FDA within 90 days of publication in the Federal Register.

The Expedited Access for Premarket Approval (EAP) is a new “voluntary program for Continue reading