Tag Archives: FDA

CDRH Releases Postmarket Cybersecurity Final Guidance

By Christopher Hanson On December 28, 2016, CDRH announced the publication of the final guidance “Postmarket Management of Cybersecurity in Medical Devices.”  In a separate post, we reported on the January 22, 2016 draft version of this guidance document.  The final guidance provides FDA’s recommendations on a risk-based framework for medical device manufacturers to assess and … Continue Reading

FDA Releases Draft Guidance on Dissemination of Patient-Specific Information by Device Manufacturers

Last month, the FDA released a draft guidance document on the sharing of patient-specific data associated with medical devices, including information recorded, stored, processed, retrieved, and/or derived from the device.  A new post on Covington’s Inside Medical Devices blog discusses the draft guidance and its implications for sharing patient information.… Continue Reading

After Two-Day Workshop, CDRH Releases Postmarket Cybersecurity Draft Guidance

By Christopher Hanson On January 22, 2016, CDRH announced in the Federal Register the publication of the draft guidance,“Postmarket Management of Cybersecurity in Medical Devices.”  The release of the draft guidance coincided with the conclusion of a two-day public workshop hosted by FDA entitled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.”  We previously discussed … Continue Reading

Cybersecurity Risks with Connected Devices

Cybersecurity vulnerability is becoming an increasing concern as medical devices are becoming more connected to the Internet, hospital networks, and other medical devices. As we previously reported, FDA has increasingly focused on promoting cybersecurity, recognizing that compromised medical devices can pose a risk to patient health and safety and to the confidentiality of personal medical … Continue Reading

FDA Releases Final Guidance on Cybersecurity in Medical Devices, Public Workshop to Follow on October 21-22, 2014

On October 2, 2014, the Food and Drug Administration (FDA) released a final guidance document titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”.  The FDA said that the “need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and … Continue Reading

FDA Issues Untitled Letter Focused On Promotional Claims On Facebook

FDA has previously included claims made on Facebook or other social media platforms along with broader allegations of misbranding using a variety of sources in its enforcement letters . . . [b]y contrast, the present untitled letter focuses solely on a single statement on a Facebook page, and does not take issue with any statements outside the Facebook page.… Continue Reading

FDA Issues Draft Guidance on Postmarketing Requirements for Promotion on Social Media

On January 13, 2014, FDA issued a draft guidance document entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.” This draft guidance addresses the procedural topic of submitting Forms FDA 2253 and 2301 when firms use social media such as blogs, microblogs, social networking sites, … Continue Reading
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