Christopher Hanson

Christopher Hanson

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Health Care Task Force Pre-Releases Report on Cybersecurity Days Before Ransomware Attack

Last week, the Health Care Industry Cybersecurity (HCIC) Task Force (the “Task Force”) published a pre-release copy of its report on improving cybersecurity in the health care industry.  The Task Force was established by Congress under the Cybersecurity Act of 2015.  The Task Force is charged with addressing challenges in the health care industry “when … Continue Reading

President Issues New Executive Order, Requires Agencies to Establish Regulatory Reform Task Forces

On February 24, 2017, President Donald Trump signed an executive order entitled “Enforcing the Regulatory Reform Agenda” (the “Order”).  The Order is one of several actions the Trump Administration has taken concerning regulatory reform since the presidential inauguration, and directs federal agencies to identify personnel to oversee the implementation of the Administration’s regulatory reform initiatives.  Among … Continue Reading

FDA Issues Discussion Paper on Possible Regulatory Approach for Laboratory Developed Tests

On January 13, 2017, the U.S. Food and Drug Administration (FDA or Agency) released a discussion paper synthesizing public feedback on FDA’s 2014 draft guidance documents and outlining a possible approach to regulation of laboratory developed tests (LDTs) (Discussion Paper). This approach is intended to “advance the public discussion by providing a possible approach to … Continue Reading

CDRH Releases Postmarket Cybersecurity Final Guidance

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 remediate cybersecurity … Continue Reading

Obama Administration Will Not Finalize LDT Framework Guidance

On November 18, 2016, the U.S. Food and Drug Administration (FDA or Agency) announced that it would not finalize the draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (Draft Guidance) prior to the end of the Obama administration. As we previously reported, FDA issued the Draft Guidance on October 3, 2014.  … Continue Reading

After Two-Day Workshop, CDRH Releases Postmarket Cybersecurity Draft Guidance

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 the Agency’s … Continue Reading

CDRH Schedules January 2016 Cybersecurity Workshop

CDRH has scheduled a cybersecurity workshop entitled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity,” on January 20-21, 2016 (see here for the Federal Register announcement). Background and Workshop Context As we discussed in a previous blog post, cybersecurity vulnerability is an increasing concern as medical devices are becoming more connected to the Internet, hospital … Continue Reading

FDA Issues Draft Guidance Concerning the Use of Electronic Informed Consent in Clinical Investigations

On March 9, FDA announced the availability of a draft guidance document focusing on the use of electronic informed consent (eIC) in clinical investigations. The document provides recommendations for investigators, sponsors, and institutional review boards (IRBs) concerning eIC, which refers to “using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, … Continue Reading

CDRH Releases 2015 Guidance Document Agenda, Announces Retrospective Guidance Document Review

On January 9, FDA announced the availability of a website that includes two lists of guidance documents that the Center for Devices and Radiological Health (“CDRH” or the “Center”) plans to publish in Fiscal Year (“FY”) 2015.  The first is a list of draft and final guidance documents that the Agency “fully intends” to publish (the … Continue Reading

FDA Releases Final Guidance Concerning In Vitro Companion Diagnostic Devices

On July 31, 2014, the Food and Drug Administration (FDA) released a final guidance entitled “In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff” (the Final Guidance). The Final Guidance explains FDA’s views on development, review, and authorization of in vitro diagnostic (IVD) devices that provide essential information for the … Continue Reading

FDA Issues Long-Awaited Draft Guidance Documents Concerning Internet/Social Media

Recently, the United States Food and Drug Administration (FDA) released two long-awaited draft guidance documents pertaining to internet and social media: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices Internet/Social Media Platforms with Character Space Limitations–Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices. The first draft guidance … Continue Reading

Senate Republicans Press FDA on Draft Guidances

On May 6, 2014, four of the ten Republicans on the United States Senate’s Committee on Health, Education, Labor, and Pensions (HELP) sent a letter (recently posted by Hyman Phelps) to FDA Commissioner Margaret Hamburg expressing “significant concern” about FDA’s penchant for using draft guidances to make “substantive policy changes.”  In addition to the Committee’s Ranking Member … Continue Reading
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