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Updated: 1 hour 49 min ago

Medical Devices at Risk of 'Urgent/11' Vulnerability

Mon, 2019-10-07 23:00
The Food and Drug Administration (FDA) is warning of 11 cybersecurity vulnerabilities that may introduce risks during the use of certain medical devices. These vulnerabilities, named “Urgent/11,” are particularly threatening because they could be used to propagate malware into and within hospital networks via their medical devices.

FDA Encourages Patient Engagement in Medical Device Development

Mon, 2019-09-30 23:00
How can the patient's perspective improve the design of the medical devices that they use? The Food and Drug Administration (FDA), though a new draft guidance, is providing recommendations for medical device manufacturers to more effectively engage patients in the design, clinical investigation process, and postmarket monitoring of their products, as well as collect and use patient engagement data in FDA submissions.

FDA Proposes Safer Technologies Program for Medical Devices

Tue, 2019-09-24 23:00
The Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) has published draft guidance that outlines a voluntary program for expediting the approval of promising treatments and diagnostics for non-life-threatening diseases.

FDA Draft Guidance Outlines Proposed Details of ASCA Pilot

Tue, 2019-09-24 23:00
The Food and Drug Administration (FDA) released a draft guidance outlining a pilot program designed to accredit third party testing laboratories for premarket review of medical devices. The guidance document defines the role of and participation criteria for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot’s accreditation bodies, test laboratories, and device manufacturers.

William 'Bill' Hyman, Dedicated Educator, Dies

Mon, 2019-09-23 23:00
William A. “Bill” Hyman, a dedicated educator, pioneering clinical engineer and prolific writer, has passed away

FDA Makes Progress on Safety and Performance Based Pathway

Mon, 2019-09-23 23:00
The Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) has issued a final guidance document related to the Special 510(k) Program, along with three other final documents describing the Abbreviated 510(k) Program, Format for Traditional and Abbreviated 510(k)s, and the agency's Refuse to Accept Policy for 510(k)s.

FDA Issues Four Guidance Documents with Aim to Modernize 510(k) Program

Mon, 2019-09-16 23:00
The Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) has issued a final guidance document related to the Special 510(k) Program, along with three other final documents describing the Abbreviated 510(k) Program, Format for Traditional and Abbreviated 510(k)s, and the agency's Refuse to Accept Policy for 510(k)s.

FDA Guidance Details Criteria for Assessing De Novo Requests

Wed, 2019-09-11 23:00
The Food and Drug Administration (FDA) has issued final guidance detailing the procedures and criteria it will use in when evaluating applications under the agency’s De Novo classification pathway, a way for new technologies to obtain marketing authorization as a Class I or II medical device rather than automatically receiving a Class III designation.

Eye-Tracking Technology Measures Severity of Brain Injuries

Mon, 2019-09-09 23:00
Traumatic brain injuries (TBIs) are often initially screened using the traditional “follow my finger” test. But can eye-tracking technology provide a more objective way to catch TBIs?

Safety Concerns Prompt FDA to Recommend Transition to ‘Innovative’ Duodenoscopes

Sun, 2019-09-08 23:00
In a recent Safety Communication, the Food and Drug Administration (FDA) urged hospitals and endoscopy facilities to “transition to duodenoscopes with innovative designs to enhance safety.” The agency's concerns stem from elevated contamination rates of "high-concern organisms” connected with conventional, fixed endcap duodenoscopes.

New TIR Helps Industry Meet Global Quality Management Expectations

Sun, 2019-09-08 23:00
A new technical information report (TIR) published by AAMI aims to help U.S. medical device manufacturers better understand Food and Drug Administration (FDA) regulatory requirements during the agency’s transition from the quality management standard 21 CFR 820 to the international standard, ISO 13485.