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Are IDE Meetings important?

An IDE stands for investigational device exemption. The meeting is usually conducted to investigate any device used in clinical practice and examine its utility and effectiveness. It is conducted to support Premarket approval (PMA). It allows clinical evaluation of certain modifications or any new legal device to be used. It is necessary before conducting any FDA-sanctioned clinical trials. An approved IDE device can be used legally and serve its purpose. A pre-IDE meeting is required before the initiation of any device. 

When is Pre IDE meeting justified? 

Companies often conduct an informal Pre-IDE meeting, about 200 meetings per year. Pre IDE meeting is required before initiating any device. It would permit the legalization of any device. So Pre-IDE meetings are justified under these conditions: 

  1. When the 510(k) pathway is unclear, or de Novo possesses a possibility. 
  2. The use of the Pre IDE process has increased. 

Typically, it takes about 60 days to schedule a meeting after submission of background information. However, upfront time may save subsequent review time. 

What are the requirements of Pre-IDE meetings? 

There are certain procedures and rules to follow before the commencement of an informal Pre-IDE meeting. It takes 60 days to set up a Pre-IDE meeting, and that is after the submission of background information officially received by the FDA. 

Non-significant risk device requires IDE meetings to be conducted with no prior FDA approval. In contrast, a significant risk device shows that an investigator is also required to act as a sponsor and file FDA approval before starting. The sponsor Investigator is required to follow certain formats and rules. The meeting may commence 30 days after submitting the background package and information unless the FDA notifies the sponsor otherwise. 

If the meeting happens to continue, the Sponsor Investigator must be eligible and meet the criteria for performing the study and required reports from FDA. It is expected that the Investigator must understand and abide by the rules and regulations to permit a wide range of projects, or else the meeting will be denied. Relevant regulations with clear guidance are a must for an investigator. 

The whole objective of such a meeting is to study an unmodified medical device that is different from the FDA approved label

Conclusion 

Such meetings are conducted to investigate a clinical device. Clinical Investigators must meet all the requirements and needs to conduct such practices and studies.

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