Improving FDA Reviews of Combination Products
The FDA and Intercenter Consultations Just a few short weeks ago, Robert Califf, [...]
3
11, 2015
29
10, 2015
FDA Guidance Answers (Some) Medical Device Cybersecurity Concerns
A new FDA guidance calls on the medical device community to be more proactive wh [...]
14
10, 2015
FDA Inspectors Leave Calling Cards For Medical Device Manufacturers Nationwide
Our latest round of warning letters emphasize the importance for medical device [...]
29
09, 2015
FDA Touts Improved IDE Review Stats
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals [...]
22
09, 2015
Got Patient Care Ideas? FDA Wants to Hear Them
As promised, the FDA just announced its first Patient Engagement Advisory Commit [...]
14
09, 2015
FDA’s New 510(k) Guidance Emphasizes Software as Device Factor
The path to medical device commercialization requires FDA approval, which most o [...]
25
08, 2015
FDA Pilot Program Encourages Quarterly Malfunction Summary Filings
FDA will be taking applications starting Sept 1, 2015, looking for makers of cla [...]
19
08, 2015
FDA Takes GUDID Offline: Security breach? Or Proactive Measures?
FDA detected a "security vulnerability" earlier this month that spooked it enoug [...]
11
08, 2015
Cybersecurity – A Real Threat to Medical Devices
The FDA just issued a Safety Communication on cybersecurity vulnerabilities of t [...]
4
08, 2015
GAO Report Finds Steady Medical Device Profit Climb – Especially the Big Boys
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals [...]
