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FDA Guidance Answers (Some) Medical Device Cybersecurity Concerns
A new FDA guidance calls on the medical device community to be more proactive when it comes to developing a solid set of [...]
FDA Inspectors Leave Calling Cards For Medical Device Manufacturers Nationwide
Our latest round of warning letters emphasize the importance for medical device manufacturers to generate and control ad [...]
FDA Touts Improved IDE Review Stats
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals Ironically, FDA is sometimes wary of is [...]
Got Patient Care Ideas? FDA Wants to Hear Them
As promised, the FDA just announced its first Patient Engagement Advisory Committee, designed to bring together patients [...]
FDA’s New 510(k) Guidance Emphasizes Software as Device Factor
The path to medical device commercialization requires FDA approval, which most often means filing a pre-marketing notifi [...]
FDA Pilot Program Encourages Quarterly Malfunction Summary Filings
FDA will be taking applications starting Sept 1, 2015, looking for makers of class I and suitable class II medical devic [...]
