Long Time Passing: Where Have All the De Novo Decision Summaries Gone?

In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process.  The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use.  This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process.

In 2012, the FDCA was modified to allow the submission of a De Novo request without the need for a prior 510(k), and set a target review time by FDA of 120 days.  Before then, to use the De Novo process a sponsor had to submit a 510(k) premarket notification, receive a decision of “not substantially equivalent” due to lack of a predicate device, and then submit a De Novo request for the device.  There was no time limit for De Novos, which meant some requests languished for prolonged periods.  For the first fifteen years after the De Novo program was established, it was basically a failure.

These legislative changes helped.  The average annual number of De Novos granted leapt. (This is a good example of Congress fixing a problem.  Of course, Congress had created the problem in the first instance.)  The average annual number of De Novos granted increased from 5 to approximately 29.

De Novos now play an important role in product advancement.  For example, FDA granted seven De Novos for COVID-19 related indications for use.  Each of these De Novos can represent a clinical advance.  Equally important, once these De Novos are authorized, they can serve as predicate devices in the 510(k) process.  In other words, De Novos serve as springboards for other new devices.

When FDA grants a De Novo, it is supposed to issue a decision summary and classification order.  Sponsors of a new 510(k) device can use the decision summary and classification order affiliated with the De Novo to learn what the De Novo applicant submitted and build the case for substantial equivalence to the De Novo device.  In effect, these documents serve as road signs helping to direct new market entrants.

These summaries can be invaluable to companies that want to get their own clearance, providing the details that can be the key to understanding what the recipient of the De Novo did.  Since 2010, FDA has posted classification orders and decision summaries for devices classified through the De Novo classification process.  The classification order identifies the special controls and therefore is extremely important.  However, the special controls tend to be high level, such as “Electromagnetic compatibility (EMC) and electrical safety testing must be performed for any electrical components” and “Software verification, validation, and hazard analysis must be performed for any software components of the device.”  This high level statement leaves many questions about details.

However, far too often, potential 510(k) applicants get to a fork in the regulatory road and find that no road signs have been posted, metaphorically speaking.  According to the Medical Device Databases webpage, the De Novo database is to be updated weekly.  When we reviewed the De Novos that were granted between CY 2022 and 2024, we saw that only 28% had decision summaries posted:

Dishearteningly, the trend is in the wrong direction.

Breaking this down further, we found that the rate of decision summaries posted varied by offices:

What’s more astonishing is the number of years that have lapsed between De Novos being granted and their decision summaries posted:

For 2024, some De Novos were recently granted and therefore do not reflect badly on FDA—yet.  The same cannot be said for De Novos from January or February.

We further identified the ten De Novos with the greatest number of days elapsed between when they were granted and the lack of a decision summary.  These numbers are accurate as of August 16, 2024:

FDA has not publicly explained why the decision summaries for De Novos are not posted in a timely manner.  FDA has said that these summaries need to go through multiple levels of review, but that cannot excuse delays of 500 days or more.  The agency has done far better in posting 510(k) summaries, which are similar types of documents.  FDA delaying the De Novo decision summary postings is contrary to their promotion of timely access to information, and hinders companies that are trying to get new 510(k)s.  We have had multiple clients who have had to guess what to submit because the De Novo summary was not available, even though the De Novo had been granted long before.

It is important that FDA posts the decision summaries in a timely fashion.  Delays unnecessarily hamper the ability for other companies to efficiently move through the 510(k) process, which also makes the review process less efficient for FDA itself.  Without the decision summaries, companies are left to guess at the study design to satisfy special controls and/or engage with FDA through the pre-submission process to obtain feedback.  FDA’s failure to post decision summaries for 70% of De Novos granted in the last 2.5 calendar years is both inexplicable and deprives patients and clinicians of options.  By taking the simple step of making summaries available faster, FDA can facilitate the clearance of new products, and make life easier for its own reviewers.