Parker Waichman LLP

Safety Reviews to Be Conducted for Older Medical Devices

U.S. regulators are finally going to review 25 types of medical devices that were marketed prior to 1976. According to a statement from the Food & Drug Administration Stan Helsing hd The Memory Keeper’s Daughter movie full (FDA), all of the medical devices slated for review were introduced prior to enactment of the Medical Device […]

U.S. regulators are finally going to review 25 types of <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">medical devices that were marketed prior to 1976. According to a statement from the Food & Drug Administration Stan Helsing hd The Memory Keeper’s Daughter movie full (FDA), all of the medical devices slated for review were introduced prior to enactment of the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976, and have never been subjected to the rigorous evaluations that are required by the law.

All of the medical devices subject to the new review are Class III medical devices. Class III devices represent the highest level of risk and generally require a showing of safety and effectiveness before they may be marketed.

After Congress enacted the medical device law in 1976, the FDA classified these 25 device types as Class III. According to The Wall Street Journal, in 1990 Congress ordered the FDA to gather rigorous evidence before a manufacturer can sell a Class III medical device. But the agency never finished the process, and has allowed hundreds of these devices to be sold based on less rigorous evaluations showing that they are “substantially equivalent” to combinations of other products marketed before 1976. According to the Journal, this type of evaluation does not require that the devices undergo patient clinical trials.

According to the FDA statement, the medical devices that are subject to the new review include heart valves and intraocular lenses. Manufacturers of these medical devices must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency’s most stringent premarket review process.

The agency has given medical device manufacturers 120 days to submit the required information. At the end of its review, the FDA will issue regulations for each device type that either will require manufacturers to submit premarket approval applications or will re-classify the devices into Class I or Class II. It could take the agency several years to finish the process.

The FDA’s oversight of medical devices has long been the subject of criticism. While consumer advocates are in favor of the agency efforts to review the safety of Class III devices, they say the whole approval process needs an overhaul.

“It’s great that FDA is finally going to look at pre-1976 devices, but the bigger problem is the low standards for approving any and all devices without clinical trials or any proof of safety or effectiveness,” Diana Zuckerman, president of the National Research Center for Women and Families, told The New York Times.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Joanne Stevens I have been working with Joanne for several months. She is responsive, compassionate and knowledgeable. My positive experience with her has been consistent with that of the entire PW team.
Cindy Spera
5 years ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value
michael dalton
2 years ago
5 Star Reviews 150
Positive: Professionalism , Quality , Value I want to say thank you to Kathy Snedecore for her awesome work ethics. She’s amazing and I appreciate her always providing updates and being on top of my Mother’s case. Thank you for everything! Me & Leyla are beyond grateful.
Gabriela Fernandez
3 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038