ARTICLE SUMMARY:
In this week’s roundup: FDA follows through on plans to revise and adopt COVID-19 510(k) exemptions for remote monitoring modifications; “structured dialogue” discussion in the EU; India extends compliance deadlines for high-risk devices; Capitol Hill hearings this week on EPA and Medicare; CMS expands stent and PET coverage; China explores monkeypox guidance; EU notified body update, and more.
Top Picks
FDA, EU, and India updates:
FDA extends COVID flex policies for remote monitoring. In a guidance published today, FDA permanently adopts COVID-19-era 510(k) exemptions for modifications to certain devices with remote monitoring features. The agency had signaled plans earlier this year to revise and maintain its COVID-19 enforcement policy for “non-invasive remote monitoring devices” beyond the now-expired Public Health Emergency, and the October 18 guidance finalizes that plan. The enforcement discretion allows manufacturers of qualifying devices to expand indications to home settings and to make certain hardware or software changes, such as adding wireless/Bluetooth capability, to increase remote monitoring capability without submitting a 510(k). The COVID-19 policy targeted 22 device types, but FDA is removing pulse oximeters and clinical electronic thermometers from the exemption categories in the post-COVID version of the policy. Cardiac monitors, blood pressure measurement systems, and cognitive assessment aids are among the 20 device types that can continue to benefit from the regulatory flexibilities.
