The draft guidance includes regulatory context in which use of real world evidence (RWE) may be appropriate, general considerations for the use of RWE, guidance on assessing data relevance and reliability, and considerations for methodologies for collection and analysis of real world data (RWD) to generate RWE.
The FDA is requesting feedback on three new draft guidances related to clinical trials, including how they should be applied to increasingly diverse trial types and data sources.
The CDRH notes that the goal of the guidance is to put safe and effective advancements in the hands of healthcare providers and users more quickly to help increase the pace of medical device innovation in the U.S. and enable more personalized medicine.
The Food and Drug Omnibus Reform Act (FDORA) authorized FDA to conduct remote device facility inspections. While it will take time for the FDA to take the necessary steps to start performing remote inspections, industry can look to remote regulatory assessments as a potential model.
“Content of Human Factors Information in Device Marketing Submissions” and “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers” are now open for comment.
The guidance seeks to balance the need to obtain data on the safety and effectiveness of drugs, biological products and medical devices in the pediatric population with risks associated with exposure to such products and the reality that children cannot themselves consent to take part in research.
The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing activities that may be applied to establish computer software assurance and meet regulatory software validation requirements.
The draft provides suggestions on device design, labeling and documentation that should be included in premarket submissions.
The document aims to clear up how the agency looks at device functions that aren’t subject to premarket review of safety and effectiveness.
FDA offers help on when and what type of clinical evaluation is appropriate for SaMD.
