The FDA proposed steps to improve government oversight of medical devices, according to The Seattle Times.
Here are eight key insights.
1. The FDA outlined proposals intended to improve the safety of pacemakers, artificial joints, medical scanners and other devices in its "Medical Device Safety Action Plan." The report was published April 17.
2. The FDA is considering implementing new safety requirements for certain devices and mandating more training for doctors who implant particular high-risk devices. The agency will also explore additional oversight of devices for women, incentives for manufacturers to improve safety and cybersecurity features for electronic devices.
3. Some measures the agency is mulling over might require new guidelines or regulations, while others might necessitate more funding from Congress.
4. The plan follows years of criticism that the FDA's framework for device regulation — which dates back to the mid-1970s — fails to catch problems with risky implants and medical instruments.
5. Under the FDA's current system, only brand new devices undergo testing in patients. Most devices are approved based on similarities to existing products on the market.
To evaluate the safety and effectiveness of devices on the market, the FDA relies on medical device reports, postmarket surveillance studies, manufacturer reports and complaints from the public, along with other methods. The "Medical Device Safety Action Plan" calls the surveillance approaches currently in use "passive."
6. "We want to have better tools for detecting issues that occur post-approval," said FDA Commissioner Scott Gottlieb, MD, who released a statement on the proposed efforts. "But we also want to have better policies to quickly intervene and better inform patients and providers if we see adverse events happening."
7. The plan primarily includes ideas and proposals. The FDA is years away from effectively implementing its safety strategies, according to National Center for Health Research President Diana Zuckerman.
8. The FDA will request more money from Congress to fund a public-private system for monitoring insurance claims, EHRs and other data sources to detect early signs of device issues. It will cost an estimated $250 million over five years for the project to become operational.