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Latest From Ferdous Al-Faruque
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.
While artificial intelligence has become the new big thing in medtech, privacy regulations under the Health Insurance Portability and Accountability Act have stayed the same. In this podcast interview with DLA Piper attorney Danny Tobey, Medtech Insight tries to get a clearer picture of what companies need to know in order to avoid running afoul of HIPAA.
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.
In this week’s Medtech Insight podcast, executive editor Shawn M. Schmitt explains how an ongoing "Quality as a Career" initiative from the Medical Device Innovation Consortium (MDIC) is aiming to train the next generation of QA experts.
After a study earlier this year found that fixed endcap duodenoscopes continued to pose a significant risk of infecting patients after being washed, the US agency is now urging providers to switch to newer-designed scopes that reduce or eliminate the risk from reprocessing, such as duodenoscopes that have interchangeable caps. The directive from the FDA is good news for Boston Scientific, which makes a disposable duodenoscope that is close to being approved by the agency.
The Medical Device Innovation Consortium has published a white paper that lists what information is needed to ensure that patients understand the risks and benefits of their treatments, as well as what are the most effective means of disseminating that information. Better communication in this area could help patients and physicians choose the right treatment while also helping researchers better inform their clinical-trial subjects.