A Smoother 510(k) Process: Strategies, Tips and Best Practices

March 1, 2019

As the FDA seeks to improve the 510(k) process, companies need to keep up with the evolving approval options. In a recent FDA News webinar, Mary Vater, a medical device consultant with Medical Device Academy, offered tips to help navigate the changes.

The FDA is going to be pushing more product down the more rigorous and expensive De Novo pathway, Vater said, especially for broadened indications or new technologies applied for the same indications. “Through the 510(k) program, a lot of product codes and a lot of devices have evolved small steps at a time, and now, the device you have going back four or five predicates, doesn’t look anything like the original predicate,” she said.

The agency also plans to establish a 510(k) pathway for a safety and effectiveness determination. “This would mean that they’re relying less on predicates and more on stand-alone safety and effectiveness, similar to the PMA or the De Novo,” she said. “They want to make sure that 510(k)s are advancing technology [that is] safer or better-performing than what’s out there [and] meets modern performance-based criteria that has been established or recognized by the FDA and that reflects current technological principles.”

The agency is also conducting several pilot programs. For example, the Quality in 510(k), also called the QUIK review, focuses on product codes that are well-understood by the FDA. The agency is testing its eSubmitter software and wants to speed up the review process by ensuring more consistency in formatting, making it easier for the FDA to review it. That could reduce the clock from 90 days to 60, Vater said.

The Special 510(k) pilot expands the types of changes eligible for the program. “There are some design and labeling changes that were previously reviewed as traditional, and they may now be eligible for Special,” Vater said. “So, if you already have a product and are just making a change, then you might push for the Special 510(k), whereas it may have previously been a traditional.” This pilot has a 30-day review clock.

Another pilot is tackling the use of third-party reviewers—companies outside of the FDA that review submissions and make clearance recommendations. The FDA has expanded the third-party review expansion pilot to permit the review of many Class II devices that were not previously eligible.

“There are some pros and cons to using third-party reviewers,” Vater said. “If you just really need a fast review, sometimes it’s worth the extra $10,000 that it costs to hire a third-party reviewer.

Another change that has both pros and cons is the evolving pre-submission meeting. Gone are the days when FDA would take a quick phone call to answer a question. The new in-person meetings are more time-consuming but they can be a company’s most useful tool in preparing 510(k) or De Novo submissions, Vater said.

To make the most of them, review and approve your design inputs first, she said. At the latest, schedule it at a design freeze or before a long-term clinical study. “The sweet spot is when you have your device descriptions fully developed, you know what your product’s going to look like, you know what it’s going to do, you know how it’s going to be used, and you also have identified your predicate and the testing that you would like to perform in order to demonstrate equivalence with your predicate, as well as safety and effectiveness if there are any differences … before you spend all the time and money to do this testing that they may or may not agree with,” Vater said.

The meetings can result in pleasant surprises, she added. In one case, a company requested a pre-sub meeting for a device it thought would be a Class 2 device. But the FDA said, based on that meeting, that the device could be classified as Class I exempt product. “That saved the client a ton of time and money, and they got to market so much quicker than if we hadn’t had that pre-sub meeting,” she said.

“I’ll be honest. Maybe 50 percent of the time you don’t get a ton of value. You’ll get some good feedback. You might get your questions answered. But 50 percent of the time you will hit gold like I have in several of my projects where it has really just made a world of difference in the project itself.”

Access the webinar FDA’s Plan for Modernizing The 510(k) Pathway here: www.fdanews.com/products/57162. — Gienna Shaw

Good Pre-Submission Meeting Questions

  • Does the FDA have any concerns regarding the selected predicate?
  • Is the justification to not do xyz testing acceptable?
  • Does the FDA agree with “worst-case” rationale?
  • Does the FDA support the decision to use a Third Party Reviewer?
  • Does the FDA support the decision to file a Special 510(k)?
  • Does the FDA support the decision to participate in a Pilot program?
  • Does the FDA anticipate any revision changes to relevant standards?

Source: Medical Device Academy