National Evaluation System For Medical Devices Under Development By FDA

Federal regulators indicate that they are working on a national evaluation system for medical devices, which is designed to better track performance, helping provide doctors and patients with better information to make informed health care decisions and aid in the regulatory process as well. 

The FDA announced the plan on April 4, as part of an effort to strengthen its post-market surveillance of medical devices. The national evaluation system‘s creation is part of the agency’s 2016-2017 strategic priorities (PDF). The plan’s details were released this month in a report (PDF) by the Duke-Margolis Center for Health Policy.

“The collaborative national evaluation system will link and synthesize data from different sources across the medical device landscape, including clinical registries, electronic health records and medical billing claims,” the agency’s announcement states. “A national evaluation system will help improve the quality of real-world evidence that health care providers and patients can use to make better informed treatment decisions and strike the right balance between assuring safety and fostering device innovation and patient access.”

Did You Know?

Change Healthcare Data Breach Impacts Millions of Customers

A massive Change Healthcare data breach exposed the names, social security numbers, medical and personal information of potentially 100 million Americans, which have now been released on the dark web. Lawsuits are being pursued to obtain financial compensation.

Learn More

The idea was first born from a stakeholder meeting in 2013, which led to a 2015 report on the development of a national post-market surveillance system.

In recent years, the FDA has faced sharp criticism from a number of sources over its post-market surveillance efforts involving both drugs and medical devices, including grassroots organizations, lawmakers, and the Government Accounting Office (GAO). The agency has been criticized over its approval and surveillance of a number of controversial devices, such as the Essure birth control implant and metal-on-metal hip replacement systems.

In addition, the GAO issued a report in January warning that the FDA was approving too many drugs via fast-track approval processes and then failing to monitor those drugs’ effects on patients to ensure they are actually safe.

The FDA hopes that the national evaluation system will help alleviate the post-marketing surveillance problems for its medical devices.

“Real-world evidence in the future will be able to support regulatory decision making across the pre- and postmarket continuum,” the FDA’s strategic priorities plan states. “To make that vision a reality, we must develop systems to ensure that data quality is appropriate and sufficient for regulatory decision making, that data flows seamlessly between systems, and that unique device identifiers (UDI) are routinely incorporated into electronic health information.”

The UDIs, which are being implemented through recent FDA regulations, are designed to help track medical devices and identify potential problems with approved products earlier, allowing federal regulators to issue recalls or require safety improvements.

1 Comments

  • BarbaraApril 5, 2016 at 9:18 pm

    I have been having pelvic pain for years blood in urine infections auto immune I have had two meshes first cliped in vagina sick for years fever over a year septic twice this last year Emergency room visits auto immune disease R.A. Worst pelvic pain of my life no sex life with out torture , first mesh eroded thru, was cliped pain only got worse with next one pack pain swelling implantitis with de[Show More]I have been having pelvic pain for years blood in urine infections auto immune I have had two meshes first cliped in vagina sick for years fever over a year septic twice this last year Emergency room visits auto immune disease R.A. Worst pelvic pain of my life no sex life with out torture , first mesh eroded thru, was cliped pain only got worse with next one pack pain swelling implantitis with dental implant vomiting gallbladder surgurey,can't do any of the things I loved dancing ,horseback riding,pool,sex with husband destroyed as I'm in immense pain sharp stabing like glass sharp pulsating heart beat left groin pain peeing all night just dribbles, can't sit with out pain wake up all night long tears running down my face driving lifting everything hurts no energy miss out on almost everything with my family, people can't live like this it's so wrong, I always thought the FDA was there to protect me, not corporations my Dad was Airforce I love America but not what is going on now ! Please help everyone my empathy and pail levels are over the hill , I now have PTSD according to doctors and I have real trust issues, no one told me I would be a lab rat!

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Depo-Provera Brain Tumor Warnings Added to Drug Label in Europe, But Not In U.S.
Depo-Provera Brain Tumor Warnings Added to Drug Label in Europe, But Not In U.S. (Posted 2 days ago)

A recently filed Depo-Provera lawsuit questions why Pfizer updated the drug label in Europe, to warn about the risk of meningioma brain tumors, but failed to provide the same Depo-Provera warnings to U.S. consumers and doctors.

Hair Relaxer Lawsuit Status Conference To Be Held With MDL Judge This Week
Hair Relaxer Lawsuit Status Conference To Be Held With MDL Judge This Week (Posted 4 days ago)

U.S. District Judge presiding over all federal hair relaxer lawsuits will meet with lawyers involved in the litigation on Thursday, to discuss the status of the claims and when to move forward with bellwether cases.