C&M Health Law

C&M Health Law

Analysis, commentary, and the latest developments in health care law and policy

Category Archives: FDA

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Interoperability by Design: FDA Issues New Final Guidance for Connected Medical Devices

Posted in FDA, Health IT
The FDA is focusing on safety and effectiveness of interconnected medical devices with the issuance of final guidance on medical device interoperability, released last week. As the FDA notes, medical devices are becoming increasingly connected to one another and to other technologies, and it is critical to address their ability to exchange and use information… Continue Reading

U.S. Copyright Office Authorizes New Access to Medical Device Programs and Data under Digital Millennium Copyright Act

Posted in FDA, Health IT
On October 28, 2015, the U.S. Copyright Office of the Library of Congress (the “Office”) issued a Final Rule containing several exemptions to the Digital Millennium Copyright Act that expanded access to medical device computer programs and the patient data they generate.  The Digital Millennium Copyright Act allows intellectual property holders to install “technological protection… Continue Reading

Trailblazing Biosimilar Approval Delivers on Biologics Price Competition and Innovation Act’s Promise and Raises New Questions

Posted in FDA
The Food and Drug Administration’s (FDA) March 2015 approval of Zarxio, the first biosimilar product licensed under the Biologics Price Competition and Innovation Act of 2009 (BPIA) is expected to usher in a new wave of faster approvals, greater choice, and lower costs for the biologics market. Along with these exciting opportunities, however, come a… Continue Reading

Sunscreen Innovation Act Paves Way for New OTC Sunscreen Ingredients U.S. Market Approval

Posted in FDA
In late 2014, Congress passed the Sunscreen Innovation Act (SIA) to speed the approval of innovative new sunscreen ingredients and formulations, many of which have long been available in Europe, Asia, and Latin America. While the SIA requires FDA to take concrete steps to more quickly review submissions regarding OTC sunscreen ingredients, the SIA does… Continue Reading

After More than Thirty Years, FDA Recommends Lifting Controversial Ban on Blood Donations From Men Who Have Sex with Men

Posted in FDA
On December 23, 2014, FDA Commissioner Margaret A. Hamburg announced that the agency favors supplanting the outright ban on blood donations from men who have sex with men (MSM) with a new policy that would prohibit donations from men who have engaged in homosexual activity in the previous 12 months. This shift for MSM would… Continue Reading

FDA Publishes Cyber Guidance for Medical Devices

Posted in FDA, HIPAA & Privacy
On October 2, 2014, the FDA released a set of comprehensive guidelines governing the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The guidelines are intended to provide direction for manufacturers of medical devices on how to appropriately safeguard devices from a potential security breach; particularly in light of the sensitive medical… Continue Reading

FDA May Consider Lifting Controversial Ban on Blood Donations from Men Who Have Sex with Men

Posted in FDA
The Food and Drug Administration (“FDA”) is considering whether to revise a controversial policy prohibiting blood donations from men who have sex with other men. Dating to 1983, the FDA policy, commonly referred to as the “MSM Deferral Policy,” which prohibits men who have had sex with other men (referred to in medical literature as… Continue Reading