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

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 ...
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 ASC

Medical Device Industry Generally Positive About FDA’s Proposed Changes to Medical Device Approval Process

The medical device industry has generally expressed satisfaction with the Food & Drug Administration’s move to revise the 510(k) device approval process, according to a Mass Device news report. • ...
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 ...
Medical News Today

What does FDA approval mean? A guide to understand the process

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...
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 ...
PBS

FDA-approved medical device raising safety concerns

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, ...
MD&M East

The Role Of Chemical Characterization In Medical Device Approval

Assessing the chemical makeup of a medical device as part of the safety evaluation can either be a blessing for manufacturers by shortening the time to market or entail some surprises, according to ...
Reuters

Consumer Reports taps ire over bad medical devices

CHICAGO (Reuters) - Consumer Reports, the 76-year-old publication best known for its reviews of automobiles and refrigerators, is trying to galvanize the American public into protesting the way ...