Truly innovative devices that do not have a “substantially equivalent” predecessor are automatically lumped into Class III, reserved for high-risk devices, and need a costly clinical trial to gain approval. But not all new products are high risk. To fix this barrier to innovation, FDA created the de novo approval pathway in 1997, enabling applicants to apply for approval as low- or moderate-risk devices.
As part of the FDA’s recent push to get devices to market faster, the agency’s device arm, CDRH, earlier this month simplified the de novo pathway with the issuance of a new draft guidance. Approval under the de novo pathway is significant because the new device clears the way for subsequent devices to be cleared via the standard 510(k) pathway. The FDA uses the initial de novo device as a beachhead to create a new “substantially equivalent” category.
According the FDA Law Blog – the blog of specialty food and drug law firm Hyman, Phelps, & McNamara – the proposal calls for the following to be included in a de novo submission or pre-submission (exact quote):
- a recommendation whether the device should be regulated as Class I or Class II;
- whether the device should be subject to 510(k) requirements;
- if a Class II device subject to 510(k), the petition should include a proposed special controls document, describing the intended use, risks, and risk mitigation strategy for the device;
- supporting protocols and data;
- a summary of benefits and known and potential risks; and
- risk and mitigation information
Also required is a classification summary proving that the there is no substantially equivalent predicate device on the market. It should include a list of databases searched, products that are potentially similar to the device and a rationale explaining why the new device is in fact different from those products.
This new requirement could be burdensome, the blog’s author, attorney Jennifer D. Newberger, wrote. “If FDA places a de novo submission on hold after concluding that insufficient information has been provided, FDA should help guide the submitter in searching for or identifying information FDA believes may be relevant,” she recommended.
Newberger said that the FDA will likely hold off on enforcing the new classification summary requirement until the issuance of the final guidance, but wrote that “it would be advisable, however, for companies to begin submitting de novo petitions with the draft requirements in mind.”
But industry could take advantage of the of 90-day comment period to lobby for the weakening or elimination of that section.
Still on the whole, she concluded that “the guidance should help industry take advantage of this (de novo) process” because it implements changes made by Congress in the 2012 Food and Drug Administration Safety and Innovation Act. In the act, Congress said that applicants no longer have to endure a rejected 510(k) application prior to submitting a de novo submission. The FDA issued a guidance moving in that direction in 2011.
The proposed reform marks another effort by the FDA to response criticism that it is too slow to approve new devices. Earlier this year, the agency proposed a new expedited access PMA process for selected devices that treat life-threatening or irreversibly debilitating diseases or conditions.