In an effort to promote innovation while protecting the population at large, the US Food and Drug Administration (FDA) has for several years been on a course to revise the existing regulatory pathway surrounding the 510(k) process for medical devices. One topic of concern focuses upon clinical data.
Historically, this has plagued device manufacturers who risk submitting their 510(k) only to discover afterwards that clinical data will be required, or that perhaps even if they submitted clinical data, it was not enough. How does one determine the responsibilities regarding clinical data requirements?
IMARC’s CEO and President, Sandra Maddock, recently published an article in ORTHOWORLD’s BoneZone Magazine titled “510(k) Clinical Data Requirements: Current Status and Considerations for Clinical Studies .” This article intends to:
• Establish the current status of the 510(k) process
• Provide answers to whether or not clinical data is required, and to what extent
• Considerations for conducting a well-controlled clinical study
After all, knowing the regulations to be followed and the responsibilities for sponsors outlined within those regulations is important in developing a strategy for compliance. Ensuring that the clinical study team has an understanding of the regulations is important throughout the clinical study process. Upfront training on the regulations for everyone involved will set the stage for a well-controlled, compliant clinical study. The end result is a clinical study in which patients are protected and the resulting data provided to the FDA to support the 510(k) submission has integrity.
Do you have any lingering questions about the 510(k) process? Let us know what you think.