Authored By: Sugato De, Vice President – Technical
Since its inception over forty-two years ago, FDA’s 510(k) clearance pathway has served as a core pillar of medical device marketing authorizations in the United States. Under this pathway, manufacturers of Class II medical devices and in vitro diagnostics have been able to pursue a streamlined path to clearance based on a demonstration of substantial equivalence to a legally marketed predicate device. Beginning in earnest with the issuance of FDA’s Medical Device Safety Action Plan in early 2018, FDA has put renewed focus on advancing multiple initiatives to enhance the safety of medical devices and keep pace with the increased complexity of rapidly evolving technologies. Last week, in the midst of an extended government shutdown, FDA issued an announcement of two key developments that signal progress toward FDA’s previously reported goal to modernize the 510(k) program. First, FDA posted its final guidance entitled “Safety and Performance Based Pathway,” which updates a draft guidance from April 12, 2018. The guidance introduces a new option for manufacturers to obtain 510(k) clearance by referencing objective performance criteria recognized by FDA to facilitate demonstrations of substantial equivalence. Second, FDA is soliciting public comment on steps the Agency can take to further enhance the safety of 510(k) devices.
Safety and Performance Based Pathway
Evolving standards of care and the proliferation of innovative technologies demand a regulatory environment where new medical devices are held to a higher bar. Patients deserve access to medical devices that conform to modern safety and performance standards, and regulators should not be expected to operate within a framework that enables the clearance of new medical devices based on comparison to outdated predicates that represent the lowest common denominator of that device type.
In this final guidance entitled “Safety and Performance Based Pathway,” FDA introduces a pathway that enables manufacturers to seek clearance by demonstrating that their device meets a predefined set of objective performance criteria rather than comparing their product to a previously approved device. Manufacturers seeking clearance under this pathway will still be required to meet the current regulatory standards for reasonable assurance of safety and effectiveness. Conceptually, the new pathway will establish a modern benchmark for new devices and offers a novel, potentially streamlined mechanism to establish substantial equivalence.
The final guidance indicates that FDA will establish and maintain a list of devices that it deems appropriate for submission through the Safety and Performance Based Pathway on its website. To date, FDA has not posted the referenced list, which practically renders the Safety and Performance Based Pathway unavailable to manufacturers at present. When issued, this list will be accompanied by device-specific guidance documents that establish applicable safety and performance criteria for each device type included. Considering the inherent difficulty in establishing objective criteria for complex device types with agreement from a broad spectrum of stakeholders, including FDA, patients, healthcare providers and industry, the creation of such guidance documents is likely to be a challenging and time-consuming endeavor. Accordingly, it can be expected that the first device types allowed to use the new pathway will be fairly low-risk products for which safety and performance criteria have been well defined in previous guidance or international standards.
As currently framed, the Safety and Performance Based Pathway does not replace or eliminate any existing 510(k) pathways, and instead provides an additional approach for clearance. However, the November 26, 2018 FDA announcement states they expect the new pathway to “eventually supplant” the current practice of manufacturers comparing the device to a single, often outdated, predicate device. This change would ultimately require federal legislation, but FDA’s actions to date clearly indicate that they consider this to be a viable and worthwhile initiative to pursue.
Phasing Out Reliance on Outdated Predicate Devices
Beyond the final guidance discussed above, FDA has also issued a notice that solicits public comment on steps that the Agency can take to encourage medical device manufacturers to develop innovations that enhance the safety of 510(k) devices. In the notice, FDA states that they are considering a list on their website of FDA-cleared devices that demonstrated substantial equivalence to older predicate devices. With respect to this issue, FDA has specifically asked for comments to address the following questions:
- Should FDA make public a list of devices or manufacturers who make technologies that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?
- Should the Agency consider using other criteria to inform its point of reference?
- Are there other actions FDA should take to promote the use of more modern predicates?
- Should the Agency consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?
FDA is requesting that comments be submitted to docket number FDA-2018-N-4751 by April 22, 2019.
The medical device industry at large has firmly stated its opposition to the potential phase out of older predicate devices. A bright-line cutoff defined by a certain number of years appears to be arbitrary and impractical for all device types as there are several device types for which the number of legally marketed predicate devices is limited. In defining the scope of allowable predicates for a given device type, FDA should carefully evaluate the number of clearances within the category, appraise the scope of innovation in the space, and assess the nature of attributable adverse events. In circumstances where safety and effectiveness standards have been relatively unchanged for a long period of time, a requirement to rely on more recent predicate devices could prove burdensome for manufacturers. A requirement for manufacturers of previously cleared devices to submit applications for reauthorization referencing newer predicates may introduce temporary gaps in the marketplace and impair provider preference. This may also be unnecessary in support of the stated goal of fostering safer and more effective medical devices. However, there are categories of medical devices where the science and applicable standard of care have clearly advanced, and it is inappropriate to continue to reference outdated predicate devices that do not meet modern safety and performance standards.
FDA’s sentiment and initiative in this area is laudable, and it is a positive sign that the Agency is seeking further input to refine its approach. Ultimately, the successful implementation of this program will depend largely on the details.
PAREXEL Consulting features dedicated subject matter expertise (including ex-FDA and industry) in the regulation of medical devices and combination products. Our experts routinely support clients in developing regulatory strategies, clinical development plans, premarket submissions and compliance programs for medical devices. PAREXEL is actively tracking updates and providing input to FDA’s 510(k) modernization initiative, and is an ideal partner to support clients in bringing innovative products to the market using optimal regulatory techniques.