RAPS

FDA Issues Guidance on 'Substantial Equivalence' Process Used to Bring Devices to Market

The US Food and Drug Administration (FDA) has issued an extensive and long-awaited guidance document on its premarket notification program—also known as the 510(k) pathway—detailing how regulators ...
Convenience Store News

FDA Streamlines PMTA Process With Improved Web-Based Options

CTP Portal Next Generation also accepts Substantial Equivalence submissions. Step-by-step instructions on completing the forms; A more user-friendly interface that helps guide applicants through the ...
Health AffairsOpinion

Increasing Reliability And Availability Of Information About Devices Used To Support 510(k) Clearance

The FDA should improve device safety by increasing the amount and availability of information about previously marketed ...
RAPS

Experts Question Impact on Innovation, FDA Authority to Pursue Revamp of 510(k) Pathway

Following Monday’s announcement from the US Food and Drug Administration (FDA) on its plans to remodel one of the review pathways for medical devices, industry trade associations pushed back on ...

Miracell Receives FDA 510(k) Clearance for SMART M-CELL PRP Concentration System and SMART M-CELL Bone Marrow Concentration System

Blood- and bone marrow-based efficient growth factors extraction system demonstrates substantial equivalence and high cell ...
National Academies of Sciences%2c Engineering%2c and Medicine

Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report

To gain a foundation on which to build its discussions, the committee commissioned two former Center for Devices and Radiological Health (CDRH) staff to draft a background paper on the 510(k) or ...