Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (Draft Guidance for Industry and FDA Staff)

Lexim Summary: This draft guidance outlines the FDA's approach to utilizing real-world data (RWD) to generate real-world evidence (RWE) for medical device regulatory decision-making. It provides comprehensive recommendations for sponsors, addressing key factors such as data relevance (availability, timeliness, generalizability) and reliability (accrual, quality, integrity). RWE applications are relevant for Investigational Device Exemptions (IDEs), premarket notifications (510(k)), and post market surveillance.  Additionally, the guidance details expectations for RWD sourced from devices authorized for emergency use and specifies submission requirements, including cover letters, fit-for-purpose assessments, protocols, and reports. Appendix B offers practical examples of RWE applications. By setting clear expectations, the FDA aims to facilitate the efficient use of RWD while maintaining rigorous evaluation standards.
 

Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response (Draft Guidance for Laboratory Manufacturers and FDA Staff)

Lexim Summary: This guidance introduces the FDA’s enforcement policy for “immediate response” in vitro diagnostic devices (IVDs) during public health emergencies when no Section 564 declaration exists. It applies to tests detecting serious or life-threatening conditions caused by novel or unusual chemical, biological, radiological, or nuclear (CBRN) agents.
Laboratories meeting specific criteria—such as CLIA certification, proper validation, and notification to the FDA—may offer these tests. Transparency about their regulatory status is also required. The document provides a framework for reporting, validation, and addressing concerns while underscoring that these tests have not undergone full FDA review or authorization.
 

Predetermined Change Control Plans for Medical Devices (Draft Guidance for Industry and FDA Staff)

Lexim Summary: This guidance outlines the FDA’s policy on predetermined change control plans (PCCPs) and provides recommendations for including PCCP information in premarket submissions. A PCCP should detail planned modifications, a protocol for their development and validation, and an assessment of their impact on safety and effectiveness.
The FDA will evaluate PCCPs as part of marketing submissions to ensure safety and efficacy without requiring new submissions for each modification. The guidance includes examples of suitable modifications for PCCPs, inappropriate use cases, and a decision flowchart for determining modification suitability.
 

Select Updates to the 506J Guidance (Draft Guidance for Industry and FDA Staff)

Lexim Summary: This draft proposes updates to the FDA's guidance on manufacturing notifications under Section 506J of the FD&C Act. The updates include introducing a "506J Device List," identifying devices critical to public health during emergencies. Factors considered include life-sustaining functionality and the risk of serious harm if unavailable.
The guidance encourages voluntary notifications about manufacturing disruptions—such as labor shortages or supply chain issues—outside of public health emergencies. Timely communication is emphasized to enhance the FDA’s ability to manage supply chain challenges effectively.