US FDA Roundup: Final Rules for Combination Products, Patient Reports for Medical Device Evaluation

The US Food and Drug Administration (FDA) has issued regulatory guidance updates affecting premarket pathways for combination products; patient-reported outcome (PRO) instruments for medical device evaluation; and patient engagement in medical device clinical study design and conduct.

Final rule on premarket pathways for combination products

Combination product manufacturers should take note that final guidance from the US Food and Drug Administration, Principles of Premarket Pathways for Combination Products, has been issued. The rule describes combination products and how the FDA works with the applicable lead center to review premarket submissions and regulate these medical components. The report offers options for pathway selection based upon the product’s primary mode of action (PMOA) and information on how to select the most appropriate type of premarket submission process for your combination product type.

FDA guidance on patient-reported outcomes for medical device evaluation

Medical device manufacturers seeking options for choosing, manufacturing, modifying and adapting patient-reported outcome (PRO) instruments for use in clinical evaluation of medical devices will find answers in the FDA’s latest guidance document on the subject. This guidance includes best practices on using the most appropriate approach to determining that these instruments are the best fit for their purpose and produce trustworthy data to aid in the regulatory and healthcare decision-making process.

Patient feedback on medical device clinical studies

Device developers and sponsors can use patient experiences, concerns, needs and preferences to enhance clinical study design and conduct, according to this latest guidance finalized by the FDA. The ruling gives examples of how to incorporate input from advisors (defined by the FDA as people who have had or currently have a certain condition or disease but aren’t clinical trial participants) into clinical investigation. The guidance also provides information on how sponsors can receive commentary from the FDA on plans to include such input in their clinical study via the Pre-Submission (Pre-Sub or Q-Sub) process.

Related US FDA medical device regulatory resources from Emergo by UL:

• US FDA 510(k) consulting for medical device and IVD companies
• FDA Pre-Sub (Q-Sub) consulting support for medical device manufacturers