Katrina’s Blog™

Data integrity continues to be a top observation during FDA inspections, with many observations leading to significant regulatory actions (warning letters, import alerts, and consent decrees). To help companies comply with expectations, the FDA has issued a new...

In December the FDA issued two rules that will affect the classification and reclassification of medical devices. The first rule, which will become final on 18MAR2019, the agency is amending 21 CFR Part 860 to establish new processes for PMA applications for...

In December, the FDA issued their first report on the impact of changes to the regulation of non-device software functions under the 21st Century Cures Act. These changes removed certain software functions from the definition of a medical device in the amended...

Guidance on When and What to File for Holders of PMAs/HDEs/IDEsCDRH and CBER have issued a new guidance clarifying the definitions of changes to a manufacturing site for medical devices and giving clearer instructions on what type of supplement to file for each type...

In early December the FDA published their Framework for Real World Evidence (RWE) Program. The intent of the program is to allow the agency to work with sponsors to evaluate the use of RWE to support approval of new indications or satisfy post-approval study...