Tag Archives: FDA

Considerations for 3D Printing of Medical Devices, Accessories, Components and Parts During the COVID-19 Pandemic

By Katrina M. Quicker, Lindsay Holmes, Lee H. Rosebush and Marc Wagner on April 13, 2020 Posted in 3D Printing

The medical device industry and the Food and Drug Administration (FDA) have been experimenting with three-dimensional (3D) printing for years. Shortages of medical devices such as personal protective equipment (PPE) and ventilators abound, making 3D printing particularly interesting with regard to fighting COVID-19. The FDA even issued some guidance on 3D printing of medical devices, … Continue Reading

Risks and Rewards of Digital Therapeutics in Treating Mental Disorders – Part II

By Michael Stein on June 25, 2019 Posted in Software

The Promise of Digital Therapeutics According to Wikipedia, digital therapeutics can be defined as a treatment or therapy that utilizes digital health technologies to spur changes in patient behavior. The first mention of the term in a peer-reviewed research publication was in 2015, in which Dr. Sepah et al. defined “digital therapeutics” as “evidence-based behavioral … Continue Reading

The Supreme Court Delivers a Win for Biosimilar Manufacturers in Sandoz v. Amgen

By Laura Gordon on June 28, 2017 Posted in Biosimilars

On June 12, 2017, the Supreme Court issued a unanimous opinion in Sandoz v. Amgen, interpreting key provisions of the Biologics Price Competition and Innovation Act (BPCIA) in favor of biosimilar manufacturers (applicants).[1] In particular, the Court held that (1) a federal injunction is not available to compel biosimilar applicants to disclose application and manufacturing … Continue Reading

As FDA Ramps Up Digital Health Program, BakerHostetler Hosts a Medical Device Connectivity Webinar Addressing Digital Technology Considerations

By Lindsay Holmes and Shannon McCue on June 9, 2017 Posted in Software

Recent reports indicate that Food and Drug Administration (FDA) plans to build a digital health unit within and assign a number of digital scientists to the Center for Devices and Radiological Health. The digital health unit addresses the proliferation of digital technology and software being used in the medical community, specifically in medical devices. As … Continue Reading