Quick Notes:
CONTEXT: USA, IVDs, RWE, Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics (IVDs)
IMPACT: step forward in providing the valuable information that IVD manufacturers and others need to address those considerations and facilitate use of RWE
Time to Read = 10 mins
Quotes from Source:
1. “ARLINGTON, Va.–(BUSINESS WIRE)–The Medical Device Innovation Consortium (MDIC) has announced the release of its Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics (IVDs).”
2. “Created through a collaborative process between MDIC, FDA CDRH, and industry partners, the framework aims to help industry and FDA consider when and how real-world data might be incorporated into product development and regulatory decision-making in support of clearance or approvals of IVDs.”
3. “A Step Forward in Using RWE for IVDs. The Real-World Evidence Framework for IVDs builds off CDRH’s guidance Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.”
4. ““MDIC’s framework document represents a step forward in providing the valuable information that IVD manufacturers and others need to address those considerations and facilitate use of RWE,” said Danelle Miller, JD, Chair of the MDIC IVD Real-World Evidence Working Group and Vice President of Global Regulatory Policy & Intelligence at Roche Diagnostics.”
5. ““We hope the framework will stir the conversations and actions needed to facilitate greater use of real-world evidence in regulatory decision-making, and ultimately, accelerate patient and healthcare provider access to innovative IVDs that are safe and effective,” said Miller.”