According to the Associated Press, the plan includes steps FDA will take immediately, as well as proposals the agency would like to implement in the future—some of which will require congressional action or federal rulemaking.
FDA said the new steps and proposals are needed to reform its "passive" system of handling medical device safety concerns. Currently, FDA relies on manufacturers, patients, and providers to report issues with medical devices. However, government assessments have found that most problems with medical devices go unreported, and issues that are reported can be inaccurate and incomplete, the AP reports. FDA said, under its current system, it can take a long time for the agency to determine whether there are "true safety concern[s]" with reported medical devices.
FDA in a release said its new "Medical Device Safety Action Plan" centers on five key areas:
- Bolstering "medical device cybersecurity";
- Creating "a robust medical device patient safety net";
- Identifying regulatory actions that would "streamline and modernize timely implementation of postmarket mitigations";
- Sparking innovation to develop "safer medical devices"; and
- Streamlining FDA activities to better prioritize safety throughout a medical device's product life cycle.
FDA said it also will consider proposals to:
- Accelerate FDA's ability to implement new safety requirements for medical devices, such as mandating that physicians who work with complex devices undergo certain training;
- Place extra scrutiny on devices intended to treat women, in response to recent issues with certain surgical tools and contraceptive devices;
- Require connected medical devices, such as defibrillators and pacemakers, to include certain cybersecurity features;
- Encourage medical device makers to improve safety, such as accelerating the approval of devices that seem to be safer than those currently on the market;
FDA also said it would ask Congress to provide the agency with more authority and funding for certain initiatives, such as:
- Addressing cybersecurity risks associated with implanted connected medical devices; and
- Creating a public-private system to monitor electronic health records, health insurance claims, and other data that could provide FDA with early signs of medical device issues.
Stakeholders expressed mixed reaction to the plan.
Scott Whitaker, president and CEO of the Advanced Medical Technology Association, in a statement said the group believes current regulations for medical devices work well, but added that the group "believe[s] every process can be improved and welcome[s] discussion of any proposal that would positively impact patient safety and access."
Ben Moscovitch, a medical device expert at Pew Charitable Trusts, praised FDA for seeking "better and more data on [the] safety and quality" of medical devices.
But Diana Zuckerman, president of the National Center for Health Research, said FDA is not moving fast enough to address medical device safety. "FDA's safety strategies for medical devices are still years away from effective implementation," she said (Baker, "Vitals," Axios, 4/18; Perrone, Associated Press, 4/17; Densford, MassDevice, 4/17; FDA release, 4/17).