FDA Adds Five Additional Unclassified Medical Devices to 510(k) Enforcement Discretion Policy
FDA has updated its guidance on unclassified medical devices, adding five additional device types to its 510(k) enforcement discretion policy. Learn what this means for manufacturers and ongoing FDA compliance obligations.
New FDA Draft Guidance Sets Bar for Cuffless Blood Pressure Devices – Clinical Performance Now in Focus
The FDA has released a draft guidance outlining new clinical performance requirements for cuffless non-invasive blood pressure devices. Manufacturers using wearable sensors or AI must now meet specific testing standards, including ISO 81060-2. Learn how these updates affect premarket submissions and regulatory strategies.