IDE (Investigational Device Exemption)

IDE (Investigational Device Exemption) Submission

We provide comprehensive support for IDE submissions, assisting manufacturers in obtaining FDA approval for the clinical investigation of high-risk medical devices, ensuring compliance with regulatory requirements and facilitating a smooth approval process.

The IDE submission process is an important requirement for manufacturers who want to conduct clinical trials on high-risk medical devices intended for human use. An IDE allows for the investigational use of a device in clinical studies, providing an exemption from the usual FDA premarket approval requirements. This process is an important step in making sure that a device is safe and effective before it hits the market.

Why ADBC CRO IDE Submissions?

  • Expert Regulatory Expertise
    Our team has extensive experience with the FDA's IDE process, ensuring a smooth and efficient submission.
  • Customized Support
    We offer tailored solutions to meet the unique needs of your clinical investigation, ensuring compliance with FDA standards and facilitating a successful outcome.
  • End-to-End Service
    From pre-submission consultation to post-approval monitoring, ADBC CRO provides full-service support throughout the entire IDE submission process.

Our services that are part of the IDE submission include

Regulatory Strategy and Planning We work with you to develop a tailored strategy for your IDE submission, ensuring that all regulatory requirements are met and that your clinical trial is well-prepared.
Pre-Submission Consultation We offer pre-submission meetings with the FDA to clarify submission expectations, address potential challenges, and ensure that your clinical trial design meets the FDA’s requirements.
Clinical Trial Design and Management We offer support in designing and conducting clinical trials to match up the guidelines set by the FDA with proper robustness and reliability and compliance of regulatory procedures.
Document Preparation and Submission We support document preparation and submission work involving a detailed description of devices, a clinical protocol, informed consent, and an investigator's brochure.
Interaction with FDA and Liaison We offer suppoThrough the IDE process, we manage all communication with the FDA, addressing any questions posed, requests for additional data required, or modifications needed in an endeavor to facilitate approval.rt after the submission for FDA queries, guiding you through the final stages of obtaining clearance.
Post Approval Services Once IDE approval is issued, we offer support in aspects of trial monitoring, reporting adverse events, and in regulatory compliance to ensure a safe and sound study in terms of integrity.

Contact us for IDE submission services and clinical investigation support!

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Regulatory Submissions