New Institute of Medicine Study Proposes Scrapping of FDA’s 510(k) Submission Process
Abstract:The Institute of Medicine has released a report that has found the FDA’s existing rules for the 510(k) clearance lacks the legal basis to be a reliable premarket screen of the safety and effectiveness.
The report has been criticized by the medical device industry while patient rights groups have welcomed its findings.
Trending Compliance Trainings
Design History File (DHF), Device Master Record (DMR) and DHR Utilizing the Principles of Lean Documents and Lean Configuration
By - Jose Mora
On Demand Access Anytime
By - Jose Mora
On Demand Access Anytime
QA Agreements for ISO 13485:2019 and other Regulatory Compliance
By - Betty Lane
On Demand Access Anytime
By - Betty Lane
On Demand Access Anytime
Understanding FDA Design Verification and Validation Requirements for Medical Devices
By - Meena Chettiar
On Demand Access Anytime
By - Meena Chettiar
On Demand Access Anytime
Deciding When to Submit a 510(k) for a Change to an Existing Device - FDA's Final Guidance
By - Angela Bazigos
On Demand Access Anytime
By - Angela Bazigos
On Demand Access Anytime
You Recently Viewed
