Just released from FDAnews — Investigations Operations Manual 2014 — the FDA’s own internal guidance on how to inspect a drug or device company. Know what the investigators look for — before they even get there.
Websites, medical meetings, television talk shows, trade shows . . . wherever your products are being mentioned, chances are good the FDA is watching and looking for violations of the rules covering promotions. And with the agency cranking out three more social media guidances in 2014, you can expect even more challenges in the way the FDA evaluates promotions in the months ahead. Now’s the time to take stock of your promotional review practices and see if they’re really covering all the places they need to – even those you might least expect. And what you can do about it if they’re not.
The Chinese Department of Health has issued a recall for Draeger Medical Hong Kong’s Delta, Delta XL, Vista XL, Gamma XXL and Kappa with software version VF6.2, VF6.3, VF6.4, VF7.1 and VF7.2 because ventricular fibrillation arrhythmias will not be recognized by the monitor and will not alarm when the Masimo SET pod is used for SpO2 measurements.