The Accreditation Scheme for Conformity Assessment (ASCA) is a program being developed by CDRH to reduce the number of sponsor questions in areas where the agency has observed inconsistent practices with respect to testing and conformance declarations. These...
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SBIA offers a great way for small businesses to get help from FDA
Small pharmaceutical companies are at a distinct disadvantage when it comes to understanding and accessing the process for new or generic drug approval. Many of these companies have one person fulfilling many roles, and their teams may have limited direct experience...
Benefit-Risk Determinations in Pre-market Approvals for Devices
– new draft and final guidanceOver the past decade, the FDA has published a number of guidance documents on benefit-risk determinations for a variety of medical device application types. This fall the agency supplemented that guidance package by releasing two...
Use of Consensus Standards to Meet Submission Requirements
The FDA hosted a webinar in October in conjunction with release of the final guidance discussing the appropriate use and documentation of consensus standards in submissions as well as how the agency intends to rely on them during review. Consensus standards (also...
What is De Novo Classification for Medical Devices?
In a previous post, I mentioned the Bose Hearing Aid was approved by CDRH under the De Novo Classification Request process. This process allows CDRH to grant premarket approval for new devices for which there is no legally marketed predicate device as a newly...
WSU Translational Medicine Symposium
Last week I participated in the 2018 Translational Medicine Symposium held on the campus of Washington State University in Spokane, WA. This annual conference is planned to discuss novel solutions for clinical problems, and this session covered clinical trials in 2...
Draft Guidance on Managing Cybersecurity in Medical Devices
Now Open for CommentThis month the FDA released a draft guidance on managing cybersecurity in Medical Devices (“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”; download the draft here). The guidance will available for public...
The Bose Hearing Aid permits user adjustment in real time
The FDA granted a De Novo classification for the Bose Hearing Aid on October 5, 2018. The De Novo program allows manufacturers to submit a request for a device to receive a new classification under categories I or II when a new medical device can be shown to have...