FDA

On March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the “DHT Framework”).  This DHT Framework is on the heels of a Discussion Paper the Agency released earlier this month on the use of artificial intelligence (AI) in drug manufacturing to seek public input on issues of critical focus (the “AI Discussion Paper”).  While both actions are significant, the AI Discussion Paper is one of CDER’s few policy statements related to the deployment of AI around regulated activities (though the Center did establish an AI steering committee in 2020).  CDRH, on the other hand, has issued several policy documents around AI-based software potentially regulated as “software as a medical device” (SaMD), including through an April 2019 discussion paper that proposed a regulatory framework for modifications to AI-based SaMD, an AI “Action Plan” for SaMD in January 2021, and guiding principles to inform the development of Good Machine Learning Practice for AI-based medical devices in October 2021.  CDER has requested public comment on the recent DHT Discussion Paper and AI Framework by May 1 and 23, respectively.Continue Reading FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development

On Wednesday, May 7, Covington attorneys Stefanie Doebler and Saurabh Anand will be participating in a webinar that might be of interest to many of the readers of this blog.  The presentation, entitled “Advertising Drugs and Health Care Products via Social Media,” will provide attendees with an overview of a recent FDA draft guidance addressing…
Continue Reading Upcoming Webinar: “Advertising Drugs and Health Care Products via Social Media: FDA Regulation”

On March 12, FDA’s Office of Prescription Drug Promotion (“OPDP”) posted an untitled letter on its webpage alleging that Institut Biochimique SA’s (“IBSA”) Facebook page for the drug Tirosint® misbranded the drug.  The untitled letter is particularly noteworthy for its focus on one statement on a firm’s Facebook page.
Continue Reading FDA Issues Untitled Letter Focused On Promotional Claims On Facebook

On January 13, 2014, FDA issued a draft guidance document entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs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  This draft guidance addresses the procedural topic of submitting Forms FDA 2253 and 2301 when firms use social media such as blogs, microblogs, social…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

On Monday, FDA released a final version of its guidance document, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff.    The guidance describes FDA’s approach for regulating certain mobile applications (apps) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).

Although the final guidance retains the basic framework…
Continue Reading FDA Releases Final Mobile Medical Apps Guidance

The issue of cybersecurity has been on FDA’s radar in the last year, due in part to a Government Accountability Office report issued last August that urged FDA to consider the risk of intentional threats to device information security.  Although the GAO report noted that FDA was not aware of any actual incident of device hacking, researchers have demonstrated the ability to remotely exploit devices such as implanted defibrillators and insulin pumps.

Addressing such threats, FDA has issued a draft guidance document entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.”  The draft guidance is intended to make “recommendations to consider and document in FDA medical  device premarket submissions to provide effective cybersecurity management and to reduce the risk that device functionality is intentionally or unintentionally compromised.”
Continue Reading FDA Issues Draft Guidance Document on Cybersecurity in Medical Devices

As our colleagues discussed in a previous post on InsideMedicalDevices, FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies.  The letter received extensive media coverage, and the mHealth sector was immediately abuzz with interest (and concern) about its implications.

Commentators observed that the letter appeared to be intended, in large part, as an educational tool for industry.  As such, it’s appropriate to ask:  what lessons should industry draw?  Although single enforcement actions do not always serve as reliable predictors of future actions, the letter offers a handful of key takeaways:
Continue Reading Lessons from FDA’s First Public Mobile Medical Apps Enforcement Letter

As was reported previously on our sister blog, InsideMedicalDevices, the regulation of mobile medical apps continues to be an issue on Congress’ radar.  Last week, the Republican-led House of Representatives Energy and Commerce Committee held three days of hearings addressing how FDA regulation and the medical device tax could affect innovation in mobile applications and devices, how technological advancements benefit patients, ways to ensure that innovation continues, and the Obama Administration’s perspective and future plans with regard to regulation of medical apps.

Christy Foreman, Director of CDRH’s Office of Device Evaluation, spoke on behalf of FDA.  She defended as a “narrowly tailored approach” the FDA’s proposed policy toward regulating mobile medical apps announced in the 2011 Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications.  (We discussed the draft guidance in a client alert and a recent article.)  Ms. Foreman also stated that the final version of this guidance is in the final stages of internal review and is expected to be issued before the end of fiscal year 2013.  The final guidance will address commenters’ requests for clarification and provide additional examples of regulated apps.  Ms. Foreman also deflected questions relating to the medical device tax, stating that taxes are not within FDA’s jurisdiction.
Continue Reading FDA Tells Congress to Expect Final Guidance on Mobile Medical Apps This Year