ARTICLE SUMMARY:
In this week’s roundup: Looking to new postmarket requirements in Canada; the latest report from the Medicare Payment Advisory Commission urges caution on diagnostics payments, and more Medicare updates; the fifth notified body has been designated under the EU IVD Regulation, and more from Europe and China; FDA updates on MDUFA V, remanufacturing, quality system; and dates to remember.
Next Picks
What we’re watching for:
New Canadian safety regs. We will be watching for the impact of an array of new postmarket device safety surveillance requirements that take effect in Canada on June 23. The new rules are tied to mandates contained in a 2014 law focused on improving drug and device safety. In particular, starting next week, holders of Canadian device licenses will be subject to requirements to submit information to Health Canada about foreign regulatory actions against a device, including safety alerts, labeling changes, and recalls. Health Canada will also have new authority to order device firms to conduct an assessment or compile information if there is new uncertainty or there are reasonable grounds to believe the benefits or risks of a device are significantly different than when a device license was issued.
