The FDA has updated the CDRH portal to allow users to track the progress of their pre-submissions. As of October 23, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using FDA’s eSTAR portal.
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 agency’s move is a win for early screening of a rare genetic disorder, which leads to progressive muscle deterioration.
The electrical nerve stimulator is intended to reduce functional abdominal pain in patients 11–18 years old.
The non-invasive trigeminal nerve stimulation system is intended for patients seven to 12 years old.
The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.
When applicable, the process provides novel products with a speedier route to market.
If all goes as planned, patients who suffer from life threatening or irreversible debilitating conditions will have faster access to new technologies.