Quality / Regulatory

The Binding Site is in strict compliance with all required regulatory and quality systems.

Regulatory Compliance

Specimenbank clinical specimens are typically collected as de-linked and de-identified diagnostic remnants, which are exempt from Title 45, Title 21, HIPAA IRB/Consent Requirements following current guideline and recommendations from :

  • FDA Center for Devices & Radiological Health (CDRH) – Office of In Vitro Diagnostics & Radiological Health (OIR)
  • FDA Center for Biologics Evaluation & Research (CBER)

Quality Assurance

In addition to our continuing commitment in achieving total product quality, Binding Sites’s manufacturing facilities are certified to the following quality standards :