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Updated: 4 hours 13 min ago

FDA Looks to Reduce Regulation, Layers of Review

Tue, 2018-03-06 23:00
The medical device industry is asking the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) for more regulatory slack on issues ranging from labeling requirements to the reporting medical device malfunctions. Such requests echo the larger call for deregulation that has characterized Donald Trump’s presidency.

CDRH Proposes Organizational Overhaul to Embrace Total Life Cycle Approach

Mon, 2018-02-26 23:00
The Food and Drug Administration’s Center for Devices and Radiological Health is proposing a major reorganization intended to promote a total product life cycle approach to regulation. The reorganization will affect the Office of Device Evaluation, the Office of Compliance, the Office of Surveillance and Biometrics, and the Office of In Vitro Diagnostics and Radiological Health.

FDA Sets ‘Good Clinical Practice’ Bar for Clinical Data Generated Outside U.S.

Mon, 2018-02-19 23:00
Reflecting the increasing globalization of clinical trials and the evolution of standards protecting trial participants, the Food and Drug Administration (FDA) has issued a final rule updating how the agency will evaluate clinical data submitted to the agency from medical device investigations conducted outside of the United States. Beginning next year, such investigations will need to conform to good clinical practice (GCP) standards, a bar typically set for studies based in the U.S.

E.U. Proposes Union-Wide Health Technology Assessments

Sun, 2018-02-04 23:00
In a regulatory move intended to speed up access to new medical technologies, the European Union has announced plans to overhaul the assessment of health technology through the use of joint clinical assessments within its 28 constituent countries. The plan would reduce the overlapping—and sometimes competing requirements—that manufacturers face when their products are evaluated in individual E.U. member countries.

FDA Delays Controversial Intended Use Rule

Mon, 2018-01-29 23:00
The Food and Drug Administration (FDA) has indefinitely delayed portions of a final rule that was intended to clarify when tobacco or tobacco-related products are regulated, but ultimately drew backlash from industry due to its inclusion of potentially far-reaching changes to the way the FDA assesses the intended use of drugs and medical devices.

Medical Device Tax Is Back on Ice—For Now

Tue, 2018-01-23 23:00
The passage of a three-week funding bill to end a federal government shutdown on Monday included one item that should put the medical device industry at ease. The continuing resolution, now signed into law, includes a provision to suspend the medical device tax, which industry has long criticized as a barrier to innovation that increases healthcare costs, for two years.

Colleagues, Friends Fondly Remember Early Sterilization Standards Leader

Mon, 2018-01-22 23:00
Friends and former colleagues of Neal Danielson are remembering him as a pioneer in the development of sterilization standards for healthcare facilities and a “true gentleman.” The tributes follow Danielson’s death in October at the age of 82.

CDRH Outlines ‘Holistic Approach’ with 2018–2020 Strategic Priorities

Sun, 2018-01-21 23:00
More engaged employees, better collaboration between stakeholders, and improvements in all-around efficiency—these are the hallmarks of the future envisioned by the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) over the next three years. These goals build on the agency’s 2012 vision to ensure that patients have access to high-quality, safe, and effective medical devices “first in the world.”

FDA Delays UDI Enforcement for Some Lower-Risk Devices

Mon, 2018-01-15 23:00
The Food and Drug Administration (FDA) has pushed back enforcement of unique device identification (UDI) compliance deadlines for some low-risk medical devices by at least two years, according to a Jan. 16 guidance document. These requirements were originally scheduled to be enforced starting this fall.

Joint Commission Names Mills’s Successor

Mon, 2018-01-15 23:00
Kenneth Monroe was appointed senior associate director of The Joint Commission's Standards Interpretation Group’s Department of Engineering in late December. Monroe replaces George Mills, who held the position for nearly 13 years.

AAMI Founder, Cardiac Surgeon Remembered for Lasting Contributions to the Field

Thu, 2018-01-11 23:00
W. Gerald Rainer, a renowned Denver heart surgeon and founding AAMI member, died suddenly of natural causes on Nov. 14, 2017, the day after his 90th birthday.

Former FDA Director, AAMI Board Member Dies at 87

Tue, 2018-01-09 23:00
Pioneering medical device regulator and early AAMI leader David Link died on Dec. 23, 2017 in Massachusetts General Hospital.

Medical Device Tax Returns to Dismay of Industry

Thu, 2018-01-04 23:00
After a two-year reprieve that many in the healthcare technology industry expected to be permanent, the medical device tax is back. This 2.3% excise tax on medical device sales, first imposed by the Affordable Care Act (ACA), was reinstated at the start of 2018 to the disappointment of many in the medical device industry. Following the passage of the ACA in 2010, the tax drew increasingly bipartisan opposition. It was eventually suspended—but not repealed—at the end of 2015.

FDA Proposes Program to More Efficiently Report Medical Device Malfunctions

Wed, 2017-12-27 23:00
Medical device manufacturers may soon have a simpler and less time-consuming way to report device malfunctions to the Food and Drug Administration (FDA) using a proposed program developed to cut down on paperwork and improve transparency during postmarket surveillance.

Divisive Medical Imaging Service Standard to Undergo Revision

Tue, 2017-12-26 23:00
A Medical Imaging & Technology Alliance (MITA) Canvass Group failed to reach consensus earlier this month on a draft American national standard for the servicing of medical imaging equipment.

FDA Says Early Clinical Research of Medical Devices Coming Back to U.S.

Wed, 2017-12-20 23:00
More than double the number of investigational device exemptions (IDEs) were submitted in 2017 compared to 2014, a sign that critical clinical research of innovative new medical devices is returning to the United States, according to the Food and Drug Administration (FDA).

HIMSS Conference to Focus on Solving Health IT Challenges

Wed, 2017-12-13 23:00
The Healthcare Information and Management Systems Society (HIMSS) will be holding its annual conference March 5–9, 2018, in Las Vegas, NV.

FDA Draws Line between Regulated and Unregulated Digital Health Products

Wed, 2017-12-13 23:00
The Food and Drug Administration has published three guidance documents, two drafts and one final, intended to clarify the agency’s role in regulating digital health products, including areas where the agency sees no need for its involvement.

FDA Commits to Modernizing Reviews, Promoting Innovation in 2018

Tue, 2017-12-12 23:00
The Food and Drug Administration (FDA) says it will step up its efforts to modernize its review process for medical devices, placing a greater emphasis on the use of postmarket data and relying more on international standards to help evaluate products in 2018.

Hospital Group Calls on FDA to Get Tougher with Device Manufacturers on Cybersecurity

Mon, 2017-12-11 23:00
A national organization representing hospitals of all sizes is calling on the Food and Drug Administration (FDA) to hold manufacturers of medical devices “accountable” for their cybersecurity practices and to flex new muscle in its oversight of industry on this front.