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
