FDA Guidance Aims To Cut Down On Incomplete De Novo Submissions
Executive Summary
To help make the review process more efficient, the US agency has published a final guidance that goes into effect in early October that lists items sponsors should submit when filing a de novo application. The FDA has created two checklists to make it easy on de novo sponsors to keep track of the documents and format them appropriately for agency review.
You may also be interested in...
Wave Of Overhauled FDA 510(k) Guidance Documents Aims To Streamline Reviews
The US agency has released four updated guidance documents aimed at providing more clarity on how it intends to review 510(k) applications. The FDA says the guidances are intended to reduce unnecessary burdens for its review staff and to help sponsors avoid wasting resources. We break down each of the docs and explain what your company needs to know.
Massive Family Dollar Rat Infestation Leads To Multi-State Recall
The US FDA found more than 2,000 rats at an Arkansas Family Dollar distribution center, leadingto a six-state recall for products including feminine hygiene products, contact lens cleaners and face masks.
Digital Health Roundup: Exec Chats With Illumina, Bloom, AngelMed; M&A, Funding; FDA Down-Classifies Apps
In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights IBM Watson Health’s divestiture and other financing news, Exec Chats with Illumina, AngelMed and Bloom, Philips’ new hand-held ultrasound device and autonomous robotic surgery, as well as the latest FDA news on digital health.