AssurX Blog
Straight talk for regulated industries.
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 medical device cybersecurity controls to assure safety and effi [...]
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 adequate records in order to produce reports when an FDA inspector [...]
FDA Touts Improved IDE Review Stats
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals Ironically, FDA is sometimes wary of issuing guidances out of concern it will appear it is imposing new [...]
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, advocacy groups, and experts to discuss complex patient care i [...]
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 notification, also known as a 510(k). The FDA has specific criteria fo [...]
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 devices to participate in an FDA pilot program to file malfunction re [...]
