The FDA: D-Day or “Try Again”?

Medical Patents Broker Inc.
By Kenneth Pearce, President

Regarding the FDA and medical device regulation, it appears that Congress enacted the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (Public Law 117-180). This Law allowed the FDA and device manufacturers to “contract” so that manufacturers would pay higher fees if the FDA generated quicker turnarounds. Because our government is “We the People,” it is designed to move at a snail's pace to protect “We the People.” Only time will tell if there truly are quicker opinions about the marketability of an invention.

Whatever time is expended seeking FDA approval decreases the time left on the patent monopoly. But without FDA permission, the medical device cannot be utilized by the patient. Even with the new promise of speedier FDA review under the MDUFA V, as some of you know, it does not always go as planned. The timeline for a “Yes” or “Try Again” still varies.

As I can discern, the following are the possibilities for a successful ruling:

1. The 510(k)

If your device is “substantially equivalent” to something already on the market, you’re likely in the 510(k) fastest lane.

• The FDA Goal: Under the MDUFA V Contract, the FDA aims to make a decision on 95% of these applications within 90 FDA days.
• The Apparent Reality: Roughly 108 to 170 calendar days. Every time the FDA requests more information (an "AI Request"), the review clock stops and the timeline lengthens.

2. The De Novo Pathway

This is for the medical device that appears low-risk but is too distinct to be forced into the “510(k) shoe.” At this point, many inventors think, “Where did we go wrong? We never expected this!” The good news: if the FDA indicates a “Go Forward,” the device could be more profitable than a standard 510(k) because you are essentially writing the rules for everyone who follows you.

• The Goal: 150 FDA days.
• The Reality: 8 to 14 months. In a backwards way, the FDA is creating the classification for the forthcoming 510(k) competitors if your device gains market share.

3. The PMA (Class III)

Welcome to the Advisory Panel. You know them: those public meetings where experts deliberate on the safety of a medical device that occasionally make the news. When there are more humans, there are more opinions, which can be pro or con to your invention.

• Total Time to Decision: Average of about 360+ days for the final decision.
• The Panel Addition: If your device goes to an advisory panel, it requires more paperwork. It is for “We the People.” With the panel’s recommendation, the FDA typically makes its final decision within 60 to 90 days of that vote.

The Silver Lining: While the delay to market is bad news, Class III medical devices can qualify for Hatch-Waxman patent term extensions to "buy back" some of that lost time. If the created market for this “Game Changer” is successful, there can be millions and millions in gross revenue generated.

4. The “No” Does Not Always Mean Go Home

Some reasons for “Trying Again” are simply administrative:

• Faulty Submission Papers: Roughly 32% of 510(k) submissions fail the initial acceptance review. Frequently, the jots or the tittles were improperly inserted. Hours expended in quadruple-checking can save months of redoing it.

The President’s Viewpoint

I despise burning capital. I envision just throwing it into one of those fire pits. Situations like this have been known to require two calcium carbonates and a pantoprazole. “We the People” is not on my mind. How to fix the mess is the priority.

How do you manage the 510(k) request for additional information?