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.
Augmented reality and extended reality will play a front-and-center role in patient care.
Designers and manufacturers of both devices and software must conduct due diligence and ensure regulatory compliance in protecting user data.
The agency wants to modernize its regulatory processes and make them more efficient.
IDE studies no longer have to rely on local IRBs; plus, changes are made to the patient threshold regarding HDE approval.
Several provisions are aimed at accelerating device innovation and access to medical products.