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.
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It’s Raining Guidance Docs: FDA Expands Abbreviated 510(k) Program
In a new final guidance, the US agency has expanded its abbreviated 510(k) program for certain devices to look beyond conformity assessments and instead look at performance criteria. Alongside the guidance, the agency also released four draft guidances for devices it is considering clearing under the new pathway.
FDA Guidance Aims To Cut Down On Incomplete De Novo Submissions
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.
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.