Enforcement Actions

When To Write A CAPA

When To Write A CAPA

A Corrective and Preventative Action (CAPA) is a tool utilized in order to address an issue or a potential issue with a product or process. According to the FDA “The purpose of the corrective and preventive action subsystem is to collect information,…

How to Submit a 510K

How to Submit a 510K

Three types of Premarket Notifications can be submitted to the Food and Drug Administration (FDA) Traditional, abbreviated, and special 510Ks. The traditional 510K program is utilized to seek marketing authorization for any device. When submitting a 510K there is not a form to submit however submission requirements can be found under 21 CFR part 807.

FDA Enforcement Actions

FDA Enforcement Actions

The FDA has numerous methods of enforcing its regulations, known as enforcement actions. There are 4 total main...

Ending a Recall

Ending a Recall

All things must inevitably come to an end, including a medical device recall. Whether voluntary or FDA mandated, all...

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