Modern technology has given rise to new legal questions. How does FDA regulate machine-learning computers that are changing so rapidly – given that the approved product may be drastically different than the product that ends up on the market? These questions arise from a lack of understanding of the complex nature of AI/ML-based SaMD, the opaqueness of the regulatory framework, and a dearth of relevant case law.
The exemption reduces the regulatory burden on the medical device industry—including the time and costs involved in preparing, submitting and responding to requests for additional information.
The FreeStyle Libre 2 now has indications for children ages four and older.
Medical device companies are committing significant resources to the fight against Covid-19. Collaboration tools can help expedite product design while supporting evolving compliance standards.
Special controls are also provided for reasonable assurance of the safety and effectiveness of the devices impacted by the reclassification.
Designers and manufacturers of both devices and software must conduct due diligence and ensure regulatory compliance in protecting user data.
This new pathway is a considerable change for the medical device industry.
The agency’s intent is to decrease regulatory burden while promoting patient access to products.
The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.
When FDA says stop, they mean stop!