US FDA provided requirement guidelines to allow three categories of medical device into market

Medical Device Diabetes Blood Test

US FDA provided requirement guidelines to allow 3 categories of medical device into market that rely on performance criteria to demonstrate safety and effectiveness.

These 3 medical device categories are spinal plating systems, orthopedic non-spinal metallic bone screws and washers, and magnetic resonance receive-only coils.

 

Contact RegASK for more details Read more

Have a
regulatory affairs
challenge?

Regulatory Affair Icon