Background and aim:
Source: SciPol
Disclaimer: Views expressed are solely of the author and have no bearing on Advy Chemical Pvt Ltd.
FDA proposes future regulatory oversight on Laboratory Developed Tests (LDTs), including a risk-based, phased-in approach, and amends key.
Synopsis
Key proposals in the FDA’s 2017 discussion paper include:
Focused Oversight : on new and significantly modified LDTs of high or moderate risk.
Risk-Based, Phased-in Oversight: the FDA proposes a four year phased-in approach for premarket review of LDTs,
Year 1: Serious adverse event and malfunction reporting
Year 2: Premarket review for new/modified LDTs with the same intended use as an in vitro diagnostic (IVD)
Year 3: Premarket review for new/modified LDTs with the same intended use as a Class II device type
Year 4: Premarket review for new/modified LDTs that do not fall into the above categories.
Evidence Standards: to complement the Centers for Medicare and Medicaid Services (CMS)’s requirements for clinical oversight.
Third-party Review program for eligible LTDs.
Clinical Collaboratives: for the development of standards for analytical and clinical validity of LDTs.
Transparency: of analytical and clinical validity reviews of all LDTs so that the public can understand the test performance and results.
Modifications: To include change protocols in their premarket submissions so that the relevant test modifications can be implemented without the need for a new premarket submission.
CMS/CLIA Quality System (QS) Requirements: Supplement CLIA QS requirements for LDTs with three requirements:
Design controls
Acceptance activities
Procedures for corrective and preventive actions
Postmarket Surveillance: for LDTs to monitor postmarket modifications and serious adverse events.
