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.
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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.
With less than one hundred days left before the European Union Medical Device Regulations kick in, Medtech Insight’s executive editor Ashley Yeo and managing editor Amanda Maxwell discuss growing concerns by medtech industry members that they may not be ready in time to comply with these regulations and may inadvertently go afoul of the new regulations.
A top clinical research expert says the medical device industry is lagging behind the pharmaceutical industry when it comes to engaging patients. While industry groups are pushing for more patient preference be factored in in regulatory decisions, John Lewis of patient advocacy group Heart Valve Voice says medtech companies themselves are not investing enough in this area.