Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Industry insiders can all agree that the U.S. Food & Drug Administration (FDA) regulates the use of medical devices. Most insiders agree that a medical device is any instrument, apparatus, implement, machine, contrivance,...more
Manufacturers of activity trackers and smartwatches have been fighting over the “serious” healthcare market for several years. Companies such as Apple (previously discussed here), Fitbit (previously discussed here), and...more
On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which updates the framework for FDA's oversight of CDS...more
On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc. had initiated a recall for the Visibly Online Refractive Vision Test, a software application offered...more
Regular readers of this blog know that we’re closely following the FDA’s proposed regulatory framework for software as a medical device (SaMD), known as precertification—Pre-Cert for short. Generally, Pre-Cert involves a...more
On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...more
On May 30, 2018, the U.S. Food and Drug Administration launched an innovation challenge as a way to combat the fight against opioid addiction. The challenge was issued to “spur the development of medical devices, including...more
The U.S. Food and Drug Administration (FDA) recently updated its software Precertification Program. A working program was originally rolled out in April 2018, but the program was updated in response to requested public input....more
Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more
The U.S. Food and Drug Administration (FDA) on Sept. 6, 2017, published the final version of its guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices. This final...more
The Food and Drug Administration (FDA) continues to flesh out its ideas for regulation of digital health. Last week, the agency published a notice in the Federal Register, announcing a pilot program to evaluate a “new...more
In recognition that the traditional regulatory approach toward moderate to high risk medical devices is not well-suited for current digital health software products, the US Food and Drug Administration published a Digital...more
Companies that develop software that functions as a medical device should be aware that the Food and Drug Administration (FDA) has issued draft guidance that, once finalized, will classify the endless variety of Software as a...more
The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...more
The Food and Drug Administration’s recent guidance on mobile medical applications illustrates the FDA’s growing efforts to combat emerging cybersecurity issues that affect patient safety. The guidance, issued in February...more
The U.S. Food and Drug Administration (“FDA”) recently issued guidance on an array of medical device-related software and systems. A first guidance for ”Data Systems and Imaging Devices” issued on February 9, 2015, and...more
The recent release of two guidance documents addressing current FDA enforcement policies for medical devices that are Medical Device Data Systems (MDDS) and mobile applications (mobile apps), provide further evidence that...more