MEDIcept Insights
FDA’s New Clinical Trial Guidance Allows you to Streamline!
On May 2, 2023, FDA published a draft guidance for Decentralized Clinical Trials for Drugs, Biological Products, and Devices – Guidance for Industry, Investigators and Other StakeHolders. In this draft guidance, the FDA states that “regulatory requirements for...
FDA “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry” Clinical Insight Paper
Introducing the game-changer in clinical investigations: The FDA has just released their highly anticipated guidance document on A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry in April 2023. This...
Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act
A “cyber device" is a device that (1) includes software validated, installed, or authorized by the sponsor as a device or in a device, (2) has the ability to connect to the internet, and (3) contains any such technological characteristics validated, installed, or...
Health Industry Cybersecurity: Managing Legacy Technology Security (HIC-MaLTS)
On March 2nd, 2023, the Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group (CWG) published a guidance, “Health Industry Cybersecurity – Managing Legacy Technology Security (HIC-MaLTS). The same day the White House published its...
A Focus on the Challenges with Utilizing Remote Monitoring in Patient Healthcare
Introduction Remote patient monitoring (RPM) technology allows healthcare providers to monitor patients without requiring them to be physically present in a healthcare facility. The potential use of remote monitoring technologies in patient health is endless in...
Team NB Position Paper Submission of Technical Documentation Highlights
On February 25, 2023, Team-NB issued a position paper titled Best Practice Guidance for the Submission of Technical Documentation under Annex II Technical Documentation and Annex III Technical Documentation for Post-Market Surveillance of EU In Vitro Diagnostic...