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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 [...]
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 notifi [...]
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 devic [...]
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 Uniqu [...]
US Drug Shortage Hits Patients, Pharmacies the Hardest
Patrick Stone, President, TradeStoneQA The corner drug store is not currently affected by many drug shortages. Instea [...]
Cybersecurity – A Real Threat to Medical Devices
The FDA just issued a Safety Communication on cybersecurity vulnerabilities of the Hospira Symbiq Infusion System. The H [...]
