Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

50+: Live Better, Longer

Font Size

Study: Recalled Devices Had Less Strict FDA Review

Researchers Say Many Recalled Medical Devices Were Approved in a Less Intensive Process

Medical Device Industry Responds

The study, which is published in the Archives of Internal Medicine, comes as the FDA is weighing changes to how it approves medical devices. It drew sharp criticism from the medical device industry, which countered that the percentages of class I (highest-risk) recalls involving products given 510(k) reviews is small compared to the absolute number of products approved under that program each year.

“There are more than 3,000 devices and diagnostics cleared through the 510(k) process every year compared to 20-40 products cleared through the PMA [premarket approval] process. To conclude that the safety profile of the 510(k) process is inferior because a larger number of 510(k) products are recalled is like concluding that the United States’ system of cancer care is inferior to Monaco’s because more people die of cancer in the U.S. each year than in Monaco without considering the population differences,” says AdvaMed, a group that lobbies for the medical device industry, in a statement.

The researchers, however, stand by their analysis, saying that they were focused on patient safety.

“Our decision to focus on the numberof high-risk recalls that were cleared through the less stringent 510(k) process, rather than the percentageof 510(k) clearances that were later recalled, is not an error in data analysis,” Zuckerman says. “It represents the public health approach to the problem, rather than the industry approach.”

Medical Devices and the FDA

The FDA classifies medical devices into three categories, based on their potential to cause harm to patients.

Class I devices are the least risky and include things like tongue depressors, bandages, and crutches. Class II devices involve intermediate risk, and these include things like hearing aids, contact lens solutions, hip and knee implants, and powered wheelchairs. Class III devices pose the most risk to patients and include things like pacemakers, heart stents, and HIV diagnostic tests.

Class III devices are intended by law to undergo premarket approval, a process that requires extensive testing, including “valid scientific evidence” to assure that a device is safe and effective for its intended use. Most class I and some class II devices are exempt from premarket approval but are cleared for market through the 510(k) process.

Today on WebMD

Eating for a longer, healthier life.
woman biking
How to stay vital in your 50s and beyond.
womans finger tied with string
Learn how we remember, and why we forget.
man reviewing building plans
Do you know how to stay healthy as you age?
fast healthy snack ideas
how healthy is your mouth
dog on couch
doctor holding syringe
champagne toast
Two women wearing white leotards back to back
Man feeding woman
two senior women laughing