DEA Extends COVID-19 Telemedicine Rules

The Drug Enforcement Administration (“DEA”), jointly with the Department of Health and Human Services (“HHS”), has announced that the current telemedicine regulations will continue in place through the end of December 31, 2024.  To view the full text of the announcement, please click here.  The full text of the extension is available here. The decision…

Read More

FDA Releases Final Guidance on Cybersecurity for Medical Devices

The Food and Drug Administration (“FDA”) has issued final guidance to advice developers on their compliance obligations for premarket submissions.  To view the FDA’s finalized document, please click here: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (fda.gov).   The guidance issued by the FDA supersedes the earlier draft guidance issued on…

Read More