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. • ...
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, ...
STAT

Many doctors are in the dark about how FDA approves devices and drugs, survey finds

In her final presentation for health policy class at the University of Chicago, first-year medical student Robin Ji informed her classmates that the Food and Drug Administration does not require ...
Becker's ASC

Medical device industry urges Congress to fund FDA’s device approval process — 5 insights

The approval backlog is here, and the medical device industry is pleading with Congress to fund the FDA during the government shutdown, Medscape reports. 1. Although the FDA has around two to three ...
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.” ...
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 ...
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 ...
National Academies of Sciences%2c Engineering%2c and Medicine

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...