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AAMI News
Updated: 3 hours 40 min ago

FDA Approves Myopia-Slowing Contact Lens for Children

Thu, 2019-12-05 23:00
The Food and Drug Administration (FDA) has granted premarket approval for the first contact lenses shown to slow the progression of myopia (i.e., nearsightedness) in children aged 8–12. The soft, disposable contact lenses, called MiSight, sharpens distance vision like a typical contact lens. Concentric rings help prevent the eye from elongating and progressively worsening the condition.

Webinar Will Provide MDS2 Insights

Wed, 2019-12-04 15:07
Join us for a free webinar hosted by the Health Technology Alliance to learn about the new version of the Manufacturer Disclosure Statement for Medical Device Security form and why it’s important for your organization.

CDRH Pilot, Innovation Challenges Address Ethylene Oxide Hurdles

Mon, 2019-11-25 23:00
The Food and Drug Association (FDA) Center for Devices and Radiological Health (CDRH) has launched a voluntary pilot project for industry to help facilitate new sterilization methods that use less ethylene oxide (EtO) and hasten approvals for sterilization site relocations. The new program is among the FDA’s recent efforts to prevent potential shortages of safe and effective medical equipment and to reduce reliance on EtO for device sterilization.

FDA Guidance Describes Process for Requesting Review of Denied Export Certificates

Mon, 2019-11-18 23:00
The Food and Drug Administration (FDA) has issued final guidance describing the process an establishment must undertake if seeking review of a denied request for a Certificate to Foreign Government (CFG) for a medical device.

Fully Implantable Heart Pump Wins FDA Breakthrough Designation

Tue, 2019-11-05 23:00
The Food and Drug Administration (FDA) has awarded breakthrough status for an implantable and fully internal left ventricular assist device (LVAD), or heart pump. Developed by Medtronic, the new LVAD design is intended to increase oxygenated blood flow through the body for patients with advanced heart failure without the need for wires leading to an external power source.

CDRH Quality Pilot Expands to Include Noncompliant Manufacturers

Thu, 2019-10-24 23:00
The Food and Drug Administration (FDA) is awarding the nonprofit Medical Device Innovation Consortium (MDIC) $2.8 million to expand their Case for Quality Voluntary Improvement Program (CfQ VIP) pilot to include medical manufacturers that are not compliant with the agency’s quality system regulations.

FDA Outlines 2020 Guidance Priorities

Mon, 2019-10-14 23:00
The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has released its final and draft guidance publication priorities for the 2020 fiscal year. This year’s announcement comes days after President Donald Trump issued a pair of executive orders aimed at curtailing enforcement actions through guidance documents.

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.