Prior to conducting a FDA sanctioned medical clinical trial, you need to have Investigational Device Approval (IDE). An article in Healing Innovations provides some good tips on when to not have a pre-IDE meeting with the FDA.
Many companies utilize the an informal pre-IDE process prior to the IDE application for the purpose of gaining insight from a FDA review team and presenting their product and testing or clinical plan. This seems like a slam dock strategy, right?
The article suggests there are times when a company needs to know when to drop the informal interaction when it no longer serves its purpose. The FDA has noted that the Office of Device Evaluation (ODE) has received complaints from the medical device industry indicating that the pre-IDE process, in some cases, was too burdensome and time consuming. Here are some of the reasons why:
- Set-up Time – There is a 60-day lead time to set up a meeting. This is after the FDA officially receives the pre-IDE submission packet.
- Open-ended Questions – Many questions that cannot be answered at the session need to be eventually addressed. It becomes challenging to schedule follow-up meeting to address them.
- Lack of Commitment – Some of the input and guidance provided can become obsolete if team members change.
- Subjectivity – Pre-IDE meetings are good if you have a good team leader. Unfortunately, these team leaders are becoming rare, which often results in a company leaving the pre-IDE meeting with more questions than those answered.
In closing, pre-IDE meetings can be worthwhile, but you need to be aware of timing and other issues that might waste valuable time and resources. Be prepared to think through the pros and cons of the process.
Do you have an example where a pre-IDE meeting was burdensome and not helpful?
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