On December 11, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner, Scott Gottlieb, posted Advancing Policies to Promote Safe, Effective MedTech Innovation on FDA’s blog, FDA Voice and discussed FDA’s plans to modernize its policy framework for the review of new medical devices. These changes will require FDA to make the review process more benefit-risk based, adopt more modern tools for evaluating safety and benefits of new products, and actively embed patient-centric measures of risks and benefits in FDA review, all while taking steps to enhance “FDA’s gold standard for safety and effectiveness.”
Under FDA’s existing framework, manufacturers of new, moderate-risk devices must demonstrate substantial equivalence to a similar device legally marketed in the U.S. in order for a new device to be cleared by FDA for use in patient care. Increasingly, this basic framework is not well tailored to reflect the current innovation in certain technologies. The predicate devices that new products must compare themselves to are sometimes 40 years old. Gottlieb recognizes that such direct comparison testing burdens applicants, especially when many new devices are designed in novel ways. His position is that this can create an obstacle to certain kinds of innovation and lead to inefficiency in the review process with few benefits to patient safety.
To address these challenges, FDA intends to publish a draft guidance in early 2018, outlining a voluntary, alternative pathway for demonstrating substantial equivalence. The Agency’s stated purpose of this framework is to allow more flexibility to use more modern criteria as the reference standard, and permit comparisons to standards that more closely approximate new technology. According to Gottlieb, the new, voluntary pathway will allow manufacturers of pre-specified categories of mature devices to “demonstrate substantial equivalence by meeting objective safety and performance criteria.” Gottlieb believes that this regulatory innovation holds great potential to streamline sponsors and FDA device review, which will help innovations more quickly get patents and allow more efficient incorporation of advanced technologies into new devices. He emphasized that these changes will still uphold FDA’s current standards for safety and effectiveness.
Additionally, Gottlieb said that in early 2018 FDA will offer draft guidance on when devices may be authorized with a level of uncertainty that can be resolved in post-market follow-up studies, rather than a pre-market setting “to allow patients to gain faster access to potentially life-saving devices, when appropriate.” In its analysis, FDA considers what level of uncertainty is acceptable about the product’s probable benefits and risks before the device is available to the public. Under FDA’s new form of review, it will “outline how it makes judgments about when it’s appropriate to place greater reliance on post-market data in order to facilitate access to certain innovation, or when the agency needs to rely more on pre-market data collection because of certain issues related to a particular product or how it may be used.”
While he discussed only two upcoming guidances in detail, Gottlieb mentioned that additional significant guidance related to FDA’s medical device review program is “forthcoming over the next several months,” and is outlined in FDA’s list of pending device-related guidance documents. The Health Law Pulse will continue to monitor any upcoming guidance.