Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Becker's Hospital Review

FDA May Toughen Medical Device Approval Process

The Food and Drug Administration may toughen is approval process for 510(k) clearance for medical devices, according to a report by the Wall Street Journal. The move causes concern for medical device ...
Becker's ASC

Minnesota Trade Group Signs with FDA to Improve Medical Device Approval Process

LifeScience Alley, the trade group for Minnesota medtech firms, signed a memorandum of understanding with the FDA’s Center for Devices and Radiological Health to develop clearer and faster procedures ...
Becker's ASC

FDA Announces 25 Actions to Improve Medical Device Approval Process

The Food and Drug Administration has released a new plan detailing 25 actions it plans to take in 2011 to improve the 510(k) approval process of medical devices, according to an FDA news release. In ...
Becker's Hospital Review

GAO Finds Flaws in FDA Device Approval Process

The Government Accountability Office (GAO) is urging the U.S. Food and Drug Administration (FDA) to use the most stringent pre-market review process in approving high-risk medical devices, according ...
MD&M East

How Early FDA Engagement Can Accelerate Medical Device Approval & Reduce Market Delays

At the upcoming MD&M East show in New York City in May, Janet Kwiatkowski, MBA, MSRA, president and CEO of MAE Group, will give a talk entitled “Importance of Early Dialog & Interaction with the FDA.” ...
JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
News Medical

The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...
abc27

KomodoSec Streamlines FDA Approval for Medical Devices with Advanced Cybersecurity

NEW CASTLE, DE, UNITED STATES, December 12, 2024 /EINPresswire.com/ -- KomodoSec Elevates Medical Device Cybersecurity, Facilitating Swift FDA 510(k) Approval ...
Medscape

FDA Tightens Approval Process for Radiotherapy Devices

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...