Last week, tech behemoth Apple signaled its interest in further pursuing the development of new medical devices with a new patent granted for an electronic device that "computes health data." According to the patent , the device computes health data based on sensors and electrical contacts with one or more body parts of the user. The device, comprised of a camera, an ambient light sensor, a proximity sensor and a processing unit communicably coupled to the camera...

The US Food and Drug Administration (FDA) this week sought to answer some frequently asked questions regarding the rollout of its new precertification pilot program for digital health products, which is expected to begin 1 September and only include nine participating companies. The third-party certification program, first announced in June by FDA Commissioner Scott Gottlieb, will assess developers based on their software development, validation and mai...

The US Food and Drug Administration (FDA) on Thursday released new details on its plans for regulating digital health technologies, including more information about its upcoming pilot program to pre-certify software-based medical devices. According to the agency's newly released Digital Health Innovation Action Plan , FDA's Center for Devices and Radiological Health (CDRH) plans to improve the landscape for digital health technologies by developing guidance on the medic...

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday announced an upcoming pilot program that would create a third-party certification program under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA review. The pilot, part of a new approach to regulating digital health tools, would help to certify, according to Gottlieb, whether a company ...

With ongoing work on guidance related to software as a medical device, and a new dedicated unit to digital health coming to the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), the agency is slowly but surely dipping its toe into the rapidly advancing field. Bakul Patel, ‎associate center director for digital health at FDA, told attendees at MedCon in Cincinnati on Thursday that current work is directed at funneling through abou...

The US Food and Drug Administration (FDA) has accepted for review what is being considered the first new drug application (NDA) for a combination product to include a sensor embedded into the tablet. The developer of the sensor – Proteus Digital Health – said it could help improve patient medication adherence and better inform physician decision-making to tailor treatments to the patient's needs. In the case of this new drug application, the sensor is paired with Otsuka...

This article analyzes adverse event reporting obligations and identifies ways to reduce regulatory risk and cost associated with digital health initiatives. The pharmaceutical industry, most would agree, has been slow to embrace the use of digital technologies, such as the cloud and mobile devices, in delivering healthcare. As with social media, pharmaceutical company involvement in digital health presents many difficult questions, making executives uneasy. Among...

In recent years, the US Food and Drug Administration (FDA) has issued several guidance documents attempting to clarify its approach to regulating medical apps. However, the authors of "A regulatory framework emerges for digital medicine," a commentary appearing in Nature this week, raise several regulatory challenges remaining unanswered. Background Since gaining oversight of medical devices through the passage of the Medical Device Amendments of 1976 , the US Food a...

New draft guidance issued by the US Food and Drug Administration (FDA) offers a high-level roadmap for developers of digital imaging devices known as digital pathology whole slide imaging devices. As explained by FDA in the guidance and elsewhere on its website, the devices are used to convert analog microscope images into digital images, making it easier to diagnose patients without the use of a microscope. The devices generally consist of a larger system of devices (ca...

This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. India’s Central Drugs Standard Control Organization (CDSCO) has published a proposal to create an information technology (IT) system that would permit the online submission of information on clinical trials by sponsors, clinical research organizations (CROs), investigators, e...

In March 2011, the European Commission launched a public consultation on an updated eHealth Action Plan for the period 2012-2020 1 , which had been called upon by the Council Conclusions on Safe and Efficient Healthcare through eHealth of December 2009 2 , and superseded the first plan adopted in 2004. Similarly, the US Food and Drug Administration (FDA) promotes the development of mobile medical apps that provide consumers and healthcare professionals with valuable he...

A recent memo from the White House to the heads of executive departments and agencies directs them to immediately begin implementation of a new "digital strategy" aimed at making governmental information more readily and easily accessible to citizens and stakeholders. The 23 May memo outlines the government's new information accessibility strategy, contained in an accompanying report entitled, " Digital Government: Building a 21 st Century Platform to Better Serve the A...