Sep 30, 2019 · Example: Software that allows a smartphone to view images obtained from a magnetic resonance imaging (MRI) medical device for diagnostic purposes

This guide provides an overview of how health insurers evaluate and determine coverage for new medical devices, including those typically covered by insurance (e.g., diabetic glucose …

For questions about this document regarding CBER-regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010, or …

CFR Title 21: Part 820, Quality System Regulation and ISO13485, Medical Device Quality Management Systems, contain a set of requirements for regulatory purposes that outline the …

Implantable cardiac devices include defibrillators, pacemakers, and their associated electrical leads. Practitioners implant these devices during either an inpatient or outpatient procedure.

What GAO Recommends We recommend HHS work with FDA: 1) to conduct workforce planning for device recalls, and 2) assess and seek, if needed, additional authority for manufacturer …

Feb 24, 2021 · In response to the National Strategy, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) led an effort to develop recommendations …