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Donawa Lifescience Consulting (DLC) > Clinical Study Submissions > US IDE Applications and IRB Submissions

US IDE Applications and IRB Submissions

DLC Clinical Regulatory Unit services include:

  • Determination of Investigational Device Exemption (IDE) requirements for:

> IDE non-exempt studies applicable to significant-risk or non-significant risk devices
> IDE exempt studies

  • Writing / review of submission documents (i.e., study protocol, informed consent, Investigator’s Brochure, Case Report Form, other documents) for compliance with applicable US requirements and recognized standards including:

> 21 CFR 812, Investigational Device Exemptions (IDEs)
> 21 CFR 50, Protection of Human Subjects and Informed Consent
> 21 CFR 54, Financial Disclosure of Investigators
> 21 CFR 56, Institutional Review Boards
> 21 CFR 11, Electronic records and signatures
> FDA-recognized standard, ISO14155

  • Determination of required study compliance with 21 CFR part 812 (exempted, abbreviated, full requirements)
  • Regulatory review of technical documents, such as, Risk Analysis, Instructions for Use,
  • Institutional Review Board (local or central) submissions
  • IDE applications to FDA
  • Submissions of amendments, renewals, yearly reports, etc. as required

The DLC Clinical Study services are managed from our headquarters in the historical centre of Rome, Italy. Contact us either by e-mail for a confidential discussion about your project, or call Daniela Karrer, VP Operations and Clinical Affairs, on +39 06 578 2665.