FDA Moves to Streamline De Novo Process
On September 30, 2011, the U.S. Food and Drug Administration (FDA) announced the release of its draft guidance, entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The Guidance comes as a part of the FDAs overhaul of its medical device review scheme, as the FDA intends to implement to streamline the way medical devices are reviewed and cleared. As previously reported, the FDA announced its plans to overhaul its entire system for reviewing and clearing medical devices earlier in 2011 and highlighted its intentions to target the “de novo” review process as a means to lessen the burden for manufacturers, while continuing its mission of public safety.
Unlike the de novo review process, the 510(k) program requires a new device to demonstrate substantial equivalence to a previously cleared device in order to obtain clearance from the FDA. The de novo process is different, as it is a means to obtain clearance for medical devices that have no clear predicates. While the de novo process currently is only open to medical device manufacturers that have submitted a 510(k) and have received a “not substantially equivalent” (NSE) determination, the FDA proposes changes to this requirement in its draft guidance.
Found here, the Guidance discusses FDAs additions to the de novo process, allowing for de novo petitions where no 510(k) has previously been submitted. The FDA proposes to institute a new pathway for de novo submissions initiated by a “pre de novo submission” (PDS). A PDS, the Agency explains, is a means for a submitter to show the FDA why its device would be suitable for the de novo process. If the FDA determines that the device would be appropriate for the de novo process, a suitability letter will be issued and the next step will be for the device sponsor to submit both a 510(k) and de novo petition concurrently with the FDA. Because the Agency would have already determined that the device is appropriate for de novo review, the idea is that the device sponsor will not have to wait for a NSE letter because the Agency will already have all the documentation it needs to clear the device through the de novo process.
While the FDA expresses optimism for the new additions to the de novo process, it remains to be seen whether the changes will bring the streamlined change that all have hoped for. Although FDA has attempted to simplify the de novo process, its proposed changes do little to combat key flaws, like the lack of transparency, that have caused so much criticism of the review of medical devices. The FDA has only published five of its de novo approval decisions to date, all of which have been published within the last year as part of FDAs Transparency Initiative.
Further, it appears that the FDAs new approach may actually complicate matters, as the Agency seeks to review two distinct submission types at once, the 510(k) and de novo petition. Because each of these submissions center largely on mutually excusive stances, with the 510(k) submission arguing that the device is substantially equivalent to a cleared device and the de novo petition asserting that the device has no clear predicates, it is unclear how the Agency will actually review the submissions.
The FDAs review of medical devices through the PMA, 510(k), and de novo processes are complex. Fuerst Ittleman has extensive experience successfully navigating medical devices through FDA review. For more information on FDAs review of medical devices, please contact us at contact@fidjlaw.com.