The U.S. Food and Drug Administration (FDA) has published a guidance document intended to help manufacturers and developers of medical device applications understand and apply the agency’s new regulations regarding the acceptance of clinical data in support of requests for FDA approval.
Published in February, the guidance “Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions” provides detailed information and recommendations on several key areas related to the collection of clinical data to be used in the FDA’s submission or application processes applicable to medical devices. Presented in a ‘frequently asked questions” format, the guidance specifically addresses provisions regarding human subject protection, institutional review boards and investigational device exemptions.
The FDA’s new requirements regarding the collection of clinical data are scheduled to take effect in early 2019.
Guidance documents are intended only to reflect the agency’s current thinking on a given subject and do not have the force of law. However, they can provide device developers and manufacturers with critical information to ensure an efficient device review process and a successful outcome.