Biomarker and Diagnostic Consulting, LLC is committed to protecting your privacy. We will not share your information with others without your written consent.
THE DATA PROTECTION ACT
Under the Data Protection Act, we have a legal duty to protect any private (non-public) information you share with us.
- We will not share or disclose any of your data or information with any third party or government agency without your permission.
- Electronic and hard-copy records will be secured at all times, and there will be restricted access to all records to prevent unauthorized use or tampering.
- After we complete our review, we will provide our decision along with the 510(k) summary, review materials, and all supporting documents to the FDA CDRH Office of Device Evaluation (ODE).
- All review records will be kept for three (3) years following the submission of review materials to the FDA. After the retention period ends, records will either be securely discarded or, if requested, transferred to the FDA.