IDE Clinical Study Submissions and Reports
The Investigational Device Exemption (IDE) allows unapproved medical devices to be used in clinical studies to collect safety and efficacy data.
We help prepare and manage:
- Pre-submission meetings with FDA
- Risk determination for significant vs. non-significant risk devices
- IDE application documentation
- Early Feasibility Studies (EFS)
- Progress reports and ongoing FDA compliance
Our support ensures your IDE process is efficient, strategic, and FDA-ready.
Trusted by top-tier teams worldwide
Featured case studies
Borderline device classification
Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and wellness product manufacturer identified revenue opportunities marketing their cosmetics devices with increase claims. Apotech was engaged to perform a blanket regulatory assessment of cosmetic devices and provide judgement and pathways for market authorisation as a medical device…
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