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The FDA’s focus on encouraging devicemakers who want to market Class III devices that could benefit patients with rare diseases or conditions has led to the humanitarian device exemption (HDE) for these very small markets.
The FDA is requiring that labeling for all food allergen skin diagnostic tests be updated to contain a warning of false negative results and potential life-threatening anaphylaxis from subsequent allergen exposure.
The FDA has cleared the Abbott FreeStyle Libre 2 and FreeStyle Libre3 continuous glucose monitoring (CGM) sensors to be integrated with automated insulin delivery systems (AID) which automatically adjusts and administers insulin based on real-time blood glucose data.
The suit’s ability to retrain corrective movement patterns without injury or exhaustion allows the patient to achieve a freedom of performance that is otherwise unattainable.
Be sure you understand the investigator’s questions during an FDA inspection – and always ask for clarification if you are unclear, advised inspection expert David Chesney, principal of DL Chesney Consulting, in a recent WCG FDAnews webinar.
Missouri-based Hi-Dow International, a manufacturer of transcutaneous nerve stimulators (TENS) units, received a form 483 for several repeat observations of failure to establish proper complaint procedures, lack of design controls, and inadequate procedures for corrective and preventive actions, among other lapses.
Neuro20 Technologies has received FDA clearance for its wearable Neuro20 PRO suit that contracts muscles to help correct habits that were formed in response to old injuries.