Becker's ASC

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 ...
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 ASC

House Hears Arguments Over FDA’s Medical Device Approval Process

House legislators heard arguments over the FDA’s regulatory process, with opposing arguments stating the approval process of medical devices is either too slow or too quick, according to a Washington ...
PBS

One medical device is raising questions about FDA’s approval process

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...
Becker's Hospital Review

Danger of morcellators highlights grave issues with FDA approval process

Uncovering the dangers associated with a common surgical tool poses a question: Why is the FDA still following a 1976 process that systematically approves devices based on similarity to other devices ...
The Times Leader

Studies: Heart device approval process lacking

CHICAGO — Two new studies find shortfalls in the Food and Drug Administration’s approval process for heart devices such as pacemakers and stents. Safety targets often weren’t clearly ...
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 ...