AssurX Blog
Straight talk for regulated industries.
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 [...]
FDA Takes GUDID Offline: Security breach? Or Proactive Measures?
FDA detected a "security vulnerability" earlier this month that spooked it enough to take the highly-touted Global Unique Device Identification Database (GUDID) offline until it was ab [...]
US Drug Shortage Hits Patients, Pharmacies the Hardest
Patrick Stone, President, TradeStoneQA The corner drug store is not currently affected by many drug shortages. Instead, the pain is being inflicted on a vulnerable group of patients [...]
Cybersecurity – A Real Threat to Medical Devices
The FDA just issued a Safety Communication on cybersecurity vulnerabilities of the Hospira Symbiq Infusion System. The Hospira Symbiq Infusion System is a computerized pump designed fo [...]
