Draft: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

The document titled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” is a draft guidance issued by the FDA aimed at clarifying how the FDA evaluates real-world data (RWD) for generating real-world evidence (RWE) to support regulatory decisions regarding medical devices. It offers expanded recommendations for sponsors considering using RWE in regulatory submissions.

The guidance outlines:

1. Introduction and Background: It sets the stage for understanding the use of RWE in regulatory decision-making and emphasizes the importance of real-world data sourced from patient health status and healthcare delivery.
2. Scope and Regulatory Context: It defines the scope of RWE use and describes the regulatory contexts where RWE might be appropriate, including general considerations, applications of Investigational Device Exemption (IDE) requirements, and the application of RWD from devices authorized for emergency use.
3. Assessing Data Relevance and Reliability: The document delves into the assessment of the relevance (availability, linkages, timeliness, and generalizability of data) and reliability (data accrual, quality, and integrity) of RWD. It emphasizes the need for data to be accurate, complete, and of adequate quality.
4. Considerations for Methodologies: It discusses methodologies for collection and analysis of RWD to generate RWE, defining study design elements and integration of data elements within study design and analysis.
5. Documentation for FDA Review: The guidance specifies what documentation should be included in regulatory submissions, covering aspects like cover letters, fit-for-purpose assessment, protocols, and reports.
6. Appendices: Appendices provide additional details on recommended elements for documentation and FDA review, as well as examples where RWE is used.

Throughout, the guidance emphasizes the importance of ensuring that RWD is fit-for-purpose, relevant, reliable, and appropriately documented to support regulatory submissions. It also notes that while this is a draft document and not yet implemented, it reflects the FDA’s current thinking and aims to guide industry and FDA staff on using RWE effectively for medical devices.

Find more: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-use-real-world-evidence-support-regulatory-decision-making-medical-devices 

For consultation on MEDGATE’s registration and import-export services ensuring compliance with current regulations, please contact us at the Hotline 098.546.1894