FDA Pre-submissions: They're a hot, timely topic.
We had a recent episode on the pre-submission process, but because there is so much to know, we decided to have our expert speaker, Mike Drues, back to make sure our listeners have the information necessary to properly deal with the FDA.
Regulatory non-compliance is one of the biggest risks that medical device companies face, and it’s so important to have a good rapport with the FDA and any other relevant regulatory agencies.
Mike Drues is the president of Vascular Sciences. He’s an expert on regulatory topics, as he works with all different types of medical device companies in addition to working with the FDA and other regulatory bodies.
Some of the topics that we discuss today include:
- Why the pre-submission process has become such a hot topic.
- The mechanics of the submission process.
- The content of the pre-submission meeting and what questions should be answered.
- Why you should not have expectations as to how long the process will take.
- How early in the pre-development process you should contact the FDA.
- Why the majority of submissions are rejected.
- How this process can help you get through changes made post-submission.
Quotes by Mike:
“The most important ingredient... is communication with the FDA.”
“At the end of the day, we want to demonstrate to the FDA that we are the experts.”
“FDA really doesn’t know anything that we don’t know.”
About The Global Medical Device Podcast:
The Global Medical Device Podcast powered by greenlight.guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.