MEDIcept Insights
510(k) vs. De Novo vs. PMA: Which FDA Pathway Is Right for Your Device?
If you're asking which FDA pathway fits your device, the short version is this: it comes down to how FDA views your device's risk, and whether a legal predicate already exists for it. A 510(k) works when you can show substantial equivalence to something already on the...
The FDA isn’t experimenting with AI anymore — it’s operationalizing it.
Regulatory expectations are evolving rapidly — driven by increased FDA scrutiny, modernization initiatives, and the growing role of data and artificial intelligence in regulatory review. MEDIcept’s Knowledge Hub brings together expert insights, white papers, and...
QMSR Compliance Deadline: February 2, 2026
The FDA’s transition to the new Quality Management System Regulation (QMSR) introduces expanded risk-based expectations, deeper inspection focus, and additional FDA-specific requirements aligned with ISO 13485. Manufacturers should begin preparations now for the February 2026 compliance deadline.
Strengthening Medical Device Security in the Age of AI Threats
Cybersecurity in medical devices has never been more critical. As connected technologies advance, so too do the risks posed by cyber threats—threats that could have direct consequences for patient safety. In a recent MD+DI article, MEDIcept’s own Gregg Van Citters,...
High-Risk IVDs Drive Immediate Transition to IVDR
The European Commission (EC) introduced 2017/746, the In Vitro Diagnostic Regulation (IVDR) back in 2017, with a transition period of 5 years, entering into force on 26 May 2022 (with differences for certain articles). As the deadline loomed, it became apparent that...
Top 5 Upcoming FDA and EU Regulations – What to Know for 2025
As the medical device industry moves into 2025, manufacturers must stay ahead of the latest regulatory changes. The FDA and EU are implementing several significant updates that will impact various aspects of device development, approval, and post-market surveillance....