Tag Archives: Software

FDA Issues Draft Guidance Document on Cybersecurity in Medical Devices

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 … Continue Reading

Lessons from FDA’s First Public Mobile Medical Apps Enforcement Letter

As we discussed in a previous post, 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) … Continue Reading

FDA Takes First Public Mobile App Enforcement Action

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.  Although FDA reportedly has approached app developers in the past about obtaining 510(k) clearances for their products, this is the first time that FDA … Continue Reading

Growth in the Wearable Sensor Market Puts New Focus on Difficult Regulatory Questions

Big news came out of the digital health industry this week, when Jawbone announced that it would acquire BodyMedia, reportedly for more than $100 million.  Both companies market products in a rapidly growing sector of the digital health industry:  wearable sensors that track and analyze users’ lifestyles.  Jawbone’s UP can track sleep, movement, and diet, … Continue Reading

FDA Issues Draft Guidance on Molecular Diagnostic Instruments with “Combined Functions” That Reflects Regulatory Creep

On April 9, 2013, FDA published a Federal Register notice announcing a new draft guidance on molecular diagnostic instruments with “combined functions” — i.e., combining functions subject to FDA approval or clearance as well as functions not subject to FDA approval or clearance (such as research use only (RUO)).  The draft guidance has significant implications … Continue Reading

New UK Guidance for Doctors on Prescribing Medical Devices and Medicines

The General Medical Council in the UK has issued new prescribing guidance for doctors that includes detailed provisions on prescribing medical devices and managing patients using medical devices. The GMC’s previous guidance was focused almost exclusively on medicines.  The new guidance recognizes that medical devices — particularly software-based devices and remote monitoring devices — are … Continue Reading

Rethinking FDA’s Regulation of Mobile Medical Apps

In the Winter/Spring edition of the SciTech Lawyer, published by the American Bar Association’s Section of Science & Technology Law, Scott Danzis and Chris Pruitt argue that FDA should rethink its approach to regulating mobile medical apps, including making significant revisions to its draft guidance document, Draft Guidance for Industry and Food and Drug Administration Staff: Mobile … Continue Reading

CJEU Clarifies Medical Device Borderline

The Court of Justice of the European Union (CJEU) has recently ruled that products which fall within the definition of a medical device, but are not intended by their manufacturer to be used for a “medical purpose,” do not fall within the scope of the Medical Devices Directive 93/42/EEC (MDD). Case C-219/11 Brain Products GmbH … Continue Reading
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