AssurX Blog
Straight talk for regulated industries.
FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR
FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR - No more paper. That's what the FDA requires from the medical device community starti [...]
FDA’s Action Plan Demands Some Industry Action, Too
“The following Pharmaceuticals FY 2015 Action Plan (the Action Plan), developed by the Office of Regulatory Affairs (ORA), the Center for Drug Evaluation and Research (CDER), and the C [...]
FDA Works to Clarify Device Data Collection Priorities
A new FDA guidance issued by the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) offers some helpful detail for device firms [...]
FDA Plays Catch Up In Brave New World of Electronic Consent
Informed consent (IC) is more than getting a quick signature from a clinical trial participant, the FDA gently reminds industry in a new guidance addressing increasingly complicated el [...]
Brookings Looks to Advance Medical Device Postmarket Surveillance System
Patients and medical device innovators will benefit if the United States is able to launch a National Device Postmarket Surveillance System (MDS), says a new report by the Brookings I [...]
FDA Gives MDDS World a Big Break
Sometimes it’s nice to be told what the FDA isn’t going to do. The agency issued a guidance last month that should give anyone building or working with a Medical Device Data System (M [...]
