by Katrina Rogers | Nov 4, 2018 | Uncategorized
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...
by Katrina Rogers | Nov 1, 2018 | Uncategorized
Now Open for CommentThis month the FDA released a draft guidance on managing cybersecurity in Medical Devices (“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”; download the draft here).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...
by Katrina Rogers | Oct 30, 2018 | Uncategorized
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...
by Katrina Rogers | Oct 28, 2018 | Uncategorized
Readers of this blog will be familiar with the webinars and workshops sponsored by CDRH as learning opportunities on the regulatory science for medical devices. If you are looking for continuing education on the subject, try the CDRH Learn page. A few new modules were...
by Katrina Rogers | Oct 25, 2018 | Uncategorized
Expanded Access (EA) is a program run by the Reagan-Udall Foundation to provide some patients with serious, life-threatening illnesses access to investigational treatments not yet approved by the FDA. Also known as compassionate use, named-patient use, or...
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