Hiring Plans Are Central To US FDA's Digital Health Plan
Hiring experts in artificial intelligence, cloud computing, cybersecurity and related fields is a central part of US FDA's recently announced "Digital Health Innovation Action Plan." The goal of the expanded team will be to make better regulatory decisions, issue new guidances and initiate a "pre-certification" pilot program for software.
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Senate Approves FDA User Fee Reauthorization Bill On 94-1 Vote
The Senate Aug. 3 swiftly approved the FDA Reauthorization Act (FDARA) on a 94-1 vote. The president is expected to sign the bill, which previously passed the House and will enact the MDUFA IV user-fee agreement and make reforms tied to device accessory review, device facility inspections, and medical imaging FDA reviews.
Software At The Speed Of Trust: US FDA Launches Pilot To Expedite Digital Health Products
Nine companies are asked to volunteer for a pilot program that could lead to a new pathway for sponsors of digital health products. Under the plan, the agency would allow firms to market a product with fewer if any pre-market review requirements based on trust developed in the company's software design and testing. If the project works out, FDA digital health leader Bakul Patel tells Medtech Insight, the agency hopes it will attract more non-traditional medical device firms that specialize in software development.
US FDA's New Game Plan For Digital Health
Commissioner Scott Gottlieb outlined his plans to implement software provisions of the 21st Century Cures Act and go much further than that in clarifying regulatory policy and piloting novel strategies to streamline the path to market for digital health technologies.