Almost There: Safety and Performance Pathway Option for 510(k) Submissions

Written by: Daniel Miranda, Globiox Consultant On 1/22/2019, the FDA posted their final guidance describing the Safety and Performance Pathway option for 510(k) submissions. This pathway gives another option for medical devices that have technological differences but that are still as safe and effective as a legally marketed predicate device. Typically, in these situations, the

Regulatory

Globiox’s team of consultants collectively, have experience in navigating regulatory pathways for a variety of life sciences products including drugs, medical devices, and combination products in both the United States and the European Union.  The regulatory landscape is constantly evolving, and Globiox prides itself on staying in tune with the latest developments.  Here is a