Published 2024
FDA's warning affects 510(k)s, De Novos and PMAs. Don't let questionable lab data derail your submission - get informed about this urgent issue.
FDA Letter to Industry
In the latest DuVal Client Alert, we provide an overview of the FDA's guidance and share insights from our experience assisting clients whose submissions were jeopardized and derailed by data integrity concerns. Learn the critical steps you should take to protect your applications.FDA's warning affects 510(k)s, De Novos and PMAs. Don't let questionable lab data derail your submission - get informed about this urgent issue.