Modernizing the FDA’s 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 3

EDITOR'S NOTE: This is the final installment of a three-part series. Read Part 1 here and Part 2 here.

The U.S. Food and Drug Administration (FDA) is considered the gold standard in regulatory oversight, so much so that dozens of countries in Asia, Africa and South America don’t regulate medical devices but rely on approvals made by the FDA and European authorities. Should device manufacturers use FDA standards as their measuring stick in global compliance?

Many companies would say yes, but the report by the International Consortium of Investigative Journalists (ICIJ) pointed out that even the FDA’s reputable oversight is lacking at times, such as when it approves complex devices too quickly and doesn’t pull troublesome ones from hospital shelves fast enough (1). The report was global in scope, but most news organizations trained the spotlight on the FDA and its 510(k) program, precisely because of the agency’s gold-standard reputation.

In this article, I will offer a practical strategy for addressing some of the anticipated changes to the 510(k) process, also known as premarket notification submission. In case you missed it, Part 1 of this three-part series focused on the highlights of the ICIJ report and the FDA’s response. In Part 2, I described the pros and cons of the program and a serious loophole that some companies are gaming.

The #ICIJ report criticizing the #510k process questions the FDA’s gold-standard reputation as a regulator. Find out why #meddevice firms should not blindly use FDA as their compliance yardstick, says @MCMastercontrol

510(k) Modernization

The ICIJ published its scathing report on Nov. 25, 2018, citing the results of its investigation that showed faulty medical devices were linked to more than 1.7 million injuries and nearly 83,000 deaths over the last decade (2).

white paper icon

Enjoying this article? You may also enjoy this White Paper:

Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations in Medical Device Environments

Download Free White Paper

In an article about the ICIJ investigation, the Associated Press noted that the streamlined 510(k) process has been blamed for some of the defective devices. “Roughly 3,000 medical devices enter the U.S. market every year through a system that generally requires little or no patient testing to verify safety and effectiveness. Unlike new pharmaceuticals, most medical devices reviewed by the Food and Drug Administration are cleared based on similarities to already-approved devices, not specific clinical trial testing,” said the news agency (3).

The day after the ICIJ report was published, the FDA announced a plan to modernize the 510(k) program, specifically to evaluate new medical devices against advances in technology, as well as to retire outdated predicates where new, safer technology is available (4).

Recent 510(k) Improvements

The modernization plan is in addition to recent changes strengthening the 510(k) process. In a recent report (5), the FDA outlined those changes, which include:

  • Dramatic increase in inspections: The agency increased its annual device inspections by 46 percent in the U.S. and by 243 percent overseas.
  • Increased voluntary recalls and adverse-event reporting: 21 CFR Part 806 requires device firms to report to the FDA any product correction or removal that’s related to a health risk. The FDA’s focus on Part 806 reporting deficiencies has resulted in a 50 percent increase in voluntary recalls since 2009.
  • More violation corrections: From 2008-2017, the agency’s risk-based inspections and increased interactions with device firms have resulted in an 82 percent increase in the number of companies that have corrected their violations on follow-up inspections.

2018-bl-modernizing-manufacturing-digital-trends-part-3-page-imageGlobal Strategy

Let’s go back to my question earlier, should medtech firms use FDA standards as their yardstick in global compliance? Yes and no. Yes, if such standard is the highest you can find, and no, if it’s not.

I recommend that you take the high ground and choose the strictest, most foolproof standard for your device. Use that rigorous standard as the foundation for your submissions in all parts of the world, even in countries that are relatively lenient. It’s the right thing to do for the safety of patients and consumers. It’s also the most prudent thing to do as a business organization. As W. Edwards Deming said, “No one can measure the loss of business that may arise from a defective item that goes out to a customer.” (6)

The ICIJ investigation has shown that not all FDA standards are created equal. The 510(k) program is a good example. Some companies use the equivalence approach under the program as a license to perform a quality shortcut. So, while 510(k) is indeed an FDA program, it’s not necessarily the strictest and highest standard available because of a loophole I call the “twilight zone.”

Here’s one way to gauge if taking the 510(k) approach is best for you. Ask yourself: how much of the clinical data from an equivalent can you actually use? If the predicate is so old that you can’t compare it with your newer data, then consider taking the De Novo pathway. Conduct a clinical trial to prove your device’s safety and efficacy. With the ICIJ report casting the 510(k) program in a negative light, you can bet that the FDA would be on the lookout for companies gaming the equivalence approach.

By 2020, when the European Union’s Medical Device Regulation (MDR) takes effect, a much stricter equivalence process would be in place in that part of the world and basing your European submission on any other standard may not cut it.

A #meddevice expert offers a practical global strategy for addressing anticipated changes in the #FDA #510k process, says @MCMastercontrol

Attaining Global Approach

Some medtech firms, especially smaller ones, will probably wonder if they have enough resources to take the strictest standard as the basis for their global submissions. The lack of resources is the biggest excuse made by companies that take advantage of the equivalence approach to get clearance for devices that are riskier than their old predicates.

Companies using paper-based systems may worry about having to hire multiple regulatory affairs teams. They may need one team to prepare the FDA submission, another team for the European MDR submission, and another for the rest of the world. All three teams will be doing the same thing, so they will be duplicating efforts.

The good news — an automated solution can provide a global platform for regulatory submissions to different countries or regions. The bad news: if you rely on a manual system, you need to automate sooner than later. In order to facilitate a holistic approach to your submissions to different regulatory bodies using the highest standards, find a robust platform that can give you the following:

  • The capability to integrate different systems your organization uses (PLM, MES, ERP, QMS) to create a single source of truth.
  • The capability to provide project visibility by region and product through dashboards, analytics and reporting functionalities.
  • The capability to track down various product expirations, registration deadlines and compliance requirements in different countries and regions.

FDA Commissioner Scott Gottlieb expressed his commitment to improve the device clearance process through modernization. “We want to push product developers to embrace newer predicates with improvements in technology so that patients and providers will continually have access to safer and more effective devices,” he said (6).

When the FDA starts implementing its modernization plan, we can expect increased reliance on newer predicates, the retirement of outdated predicates, and hopefully, the end of the 510(k) twilight zone. In the meantime, I challenge all medtech companies to up their game and use the highest standards as their yardstick in global compliance.



(1, 2) “Medical Devices Harm Patients Worldwide as Governments Fail on Safety,” ICIJ, Nov. 25, 2018.

(3) “FDA’s ‘Flawed’ Device Pathway Persists with Industry Backing” by Matthew Perrone, the Associated Press, Nov. 27, 2018.

(4) FDA press announcement, Nov. 26, 2018.

(5) “Medical Device Enforcement and Quality Report,” published by the FDA, Nov. 2018.

(6) The Essential Deming: Leadership Principles, the Deming Institute website.

(7) FDA Commissioner Scott Gottlieb’s press statement, Nov. 27, 2018.


2016-bl-thumb-alex-butler Alex Butler is MasterControl’s manager of medical device solutions. He leads the development efforts for MasterControl Registrations and MasterControl Regulatory Excellence.He’s also responsible for developing and/or improving other software solutions, namely MasterControl Customer Complaints, Bill of Materials (BOM), Projects, Risk Management, and PDM Connector. His medical device experience includes working as a product development manager for Opal Orthodontics, a division of Ultradent Products Inc., where he helped launch several Class II medical devices.