AssurX Blog
Straight talk for regulated industries.
RAPS Preview: FDA CDRH Director Shuren Talks Priorities
FDA CDRH or Center for Devices and Radiological Health Director Jeff Shuren, MD, JD, will outline the agency's ambitious 2017 goals at a vitally important session that's part of the R [...]
FDA Eases Up a Bit on Enforcement Gas Pedal as Warning Letters Decline
Medical device warning letters and domestic inspections continue to show a slow decline, according to a new report issued FDA. The number of medical device-related warning letters dipp [...]
Improving FDA Reviews of Combination Products
The FDA and Intercenter Consultations Just a few short weeks ago, Robert Califf, the US Food and Drug Administration (FDA) Commissioner nominee, endorsed an internal report that provi [...]
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 [...]
