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FDA Releases 3D Printing at the Point of Care Discussion Paper

Developing technologies in manufacturing, patient-matching and timely personalized patient care have identified the need to establish guidance and policy around the regulatory responsibilities of entities engaging in Point of Care (PoC) 3D printing. On December 10, 2021, the U.S. Food and Drug Administration (FDA) released a discussion paper regarding 3D printing medical devices at the … Continued

FDA Announces Release of “Playbook for Threat Modeling Medical Devices”

On November 30, 2021, the U.S. Food and Drug Administrations (FDA) announced the release of a new playbook to assist medical device manufacturers in developing and evolving threat modeling approaches to strengthen the cybersecurity and safety of their products. The new “Playbook for Threat Modeling Medical Devices,” commissioned by the FDA and co-authored by MITRE Corporation … Continued