Big changes are planned in 2018 and beyond for how new medical devices are reviewed and approved by the U.S. Food and Drug Administration (FDA) if a proposal put forth moves forward.
In a blogpost this week, FDA Commissioner Scott Gottlieb, M.D. announced the FDA’s Center for Devices and Radiological Health (CDRH) will publish a series of new draft policy guidance in early 2018 aimed at streamlining and modernizing certain new medical device approvals “to allow patients to gain faster access to potentially life-saving devices, when appropriate.” Dr. Gottlieb says the changes he is championing to an outdated 40-year-old way of operating will make the FDA’s medical device approval processes “more benefit-risk based” and “transparent, consistent, and objectively-defined.”
One of the major shifts expected to come from the policy turn is an increased agency reliance on post-market data collection and analysis in evaluating the safety and performance of certain medical devices.
Current law states that a moderate-risk medical device that is substantially equivalent, or similar, to any previously (section 510(k)) cleared device or any device that was on the market when the Medical Device Amendments of 1976 were enacted —referred to as a predicate device — can be cleared for marketing with some exceptions. When a device is found to be substantially equivalent to a predicate device, the new device is assumed to be as safe and effective as the predicate because of its similarity. Devices that were on the market before the Medical Device Amendments were never systematically assessed for safety and effectiveness — but they are being used as predicate devices.
Dr. Gottlieb and the agency he oversees contend the current structure and processes for evaluating new medical devices are not well-suited to incorporate the technological medical innovation occurring today, and how the FDA must evaluate those technologies against older ones. Old and new are not always a fair apple to apples comparison, he says, and therefore any such evaluation fails to serve the healthcare consuming public.
“FDA recognizes that such direct comparison testing creates burdens for 510(K) applicants, especially when many new devices are designed in novel ways, using more advanced technologies,” Gottlieb wrote. “It’s sometimes hard to identify sufficient, appropriate predicate devices in order to conduct testing. This can create an obstacle to certain kinds of innovation and lead to inefficiency in the review process with few, if any, benefits to patient safety.”
As proposed, Dr. Gottlieb contends, the agency’s proposed more progressive approach will allow it to evaluate new medical devices differently. The new approach will unlock medical innovation getting devices on the market quicker and relying more on post-market follow-up studies when a device’s public health need and benefit outweighs any “acceptable levels of uncertainty” revealed in pre-market evaluation. In all instances of accelerated device approval, he says, the FDA must have confidence that the agency can acquire required post-market data to ensure safety and efficacy.
It is clear from the evidence that such a change to existing practice will require a more vigorous post-market clinical study approach than is currently occurring. Robust post-marketing surveillance and studies will become essential if the FDA proposed changes move forward. Among the evidence: a 2015 Yale-led study published in JAMA concluded that just 13% of initiated post-market studies of high-risk medical devices were completed between three and five years after FDA approval.
Even before the FDA’s announcement this week, an Institute of Medicine committee previously found that the FDA should clarify and fortify its post-market regulatory powers, including enforcing the completion of post-market clinical studies and seizing or banning medical devices where post-market data finds them deficient.
Additionally, for the FDA’s proposals to succeed when enacted the medical device industry and the FDA will need to also:
- Develop expertise in mapping out “Human Factors Studies” which will become much more important if devices are introduced with less reliance on a comparator or fast-tracked with limited pre-approval data
- Make sure industry and regulatory structure is in place for Real World Evidence (RWE) generated by the medical technology (such as wearables) to be relied upon more in pre- and post-market studies and review of medical devices to validate long term sustainability and effectiveness
- Consider creating a consortium/partnership for post-market medical device safety monitoring that taps elements from clinical research community’s experience on the drug development side
- Consider how the changes will or will not work with regulatory structures outside the United States. Most medical devices today are developed for a global marketplace
The FDA and regulatory authorities across the globe need to continue communicating through the International Medical Device Regulators Forum (IMDRF) to evaluate requirements in individual countries and harmonize regulatory approaches to digital health medical devices, where possible.
Some early critics of the FDA’s proposed changes to accelerating medical device market approval contend they are a threat to patient safety in the United States. They maintain there are already too many FDA recalls and bad examples of medical devices being placed on the market too soon.
Dr. Gottlieb says the proposed changes will only strengthen FDA’s gold standard for safety and effectiveness. Supporters of the FDA proposals say the changes, if implemented, could save medical device companies millions of dollars, shave years from development times, and most importantly spur healthcare innovation that improves medical care and reaches medically needy patients faster.
For the changes Dr. Gottlieb advocates to work, and all sides to feel comfortable, stronger post-market monitoring, clinical study and recall guardrails must be erected in any policy guidance changes or through other legislation before the proposal goes full throttle.
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