regularly use IVDs to diagnose conditions, guide treatment decisions, and even mitigate or prevent future disease (for example, through screening tests that indicate a patient’s risk of developing a given condition in the future). Since the passage of the Medical Device Amendments of 1976, FDA has regulated medical devices, which
On the basis of this determination, the Secretary of HHS declared that circumstances exist justifying the authorization of emergency use of certain in vitro diagnostics for the detection and/or
Contact our pharma solutions experts to design a custom program to accommodate the needs of your study. We have proven expertise critical to the successful development, validation, and commercialization of in vitro diagnostics and share your commitment to scientific rigor, patient safety, and regulatory compliance. 1 Authorized settings noted as 'Near Patient/Point-of-Care' include environments where the patient specimen is both collected and analyzed and the test is performed by a qualified, trained j6l4R. 443 414 82 369 267 89 95 443 328