Business

7 Common Mistakes to Avoid When Submitting a 510K to the FDA

Published

4 years ago

January 21, 2022

The FDA deserves credit for ensuring high patient safety standards. However, there is no ignoring the hassle medical device manufacturers go through when submitting 510K applications. They spend hours collecting documents and data from multiple departments only to face a 36% prospect of having their application rejected.

While there is no formula to always getting your submissions cleared by the FDA, you can increase your chances of approval and avoid delivery delays and unnecessary stoppages by ironing out things on your end. Here are some of the most common mistakes manufacturers make that you can easily avoid:

1. Losing track of your product’s regulatory history

Your company ought to know its product’s regulatory history in the U.S., since that’s what 510Ks are based on. Unfortunately for most companies, poor data-keeping leads to loss of important information resulting in a bitter clash with the FDA. No matter the history of your product, it’s good to keep data where you can access it and not likely to lose it. A dedicated clinical metadata repository software tool, such as Formedix Ryze can help you take control of the key challenges associated with keeping and organizing data.

2. Using incorrect FDA templates

Up in the FDA checklist is the correct use of their templates. The agency requires that each section of all 510K submissions be based on an FDA-issued template. Most manufacturers remember this but then forget how rapidly the FDA updates these templates. While using an older template doesn’t automatically render your submission void, it increases your chances of leaving out some data, which you can’t get away with. For this reason, it’s good to confirm that the template on your hands is the latest issued by the FDA before drafting your application.

3. Data irregularity

The FDA requires that you be consistent with the information you provide if it appears multiple times in your application. If there is a discrepancy in your wording, your application will likely be flagged and even rejected. So while keeping your intent consistent, make a point of doing the same with your wording for the sake of your application’s approval.

4. Skipping sections

A typical 510K application form has 20 sections, some of which may not apply to your device. For most manufacturers, irrelevant sections include Electromagnetic Compatibility and Electrical Safety, Performance Testing and Proposed Labeling, Disclosure Statement or Financial Certification, and Class 3 Summary and Certification. If any of the sections don’t apply to you, it is required that you confirm it in writing.

5. Choosing an incorrect predicate (comparison) device

The FDA will treat your device like they did a previously cleared one, meaning you have to identify a device whose parameters match those of yours. Your predicate of choice should bear similarity in design, size, materials, packaging, indications for use, and other considerations, failure to which you will draw out the review process, and even risk rejection. For instance, if your device requires sterilization before use, while the predicate is supplied sterilized, the FDA will ask for more information before getting on with the review process.

6. Failing to comply with the Refusal to Accept provisions

Nearly 90 percent of all rejected submissions are tossed out before being reviewed by a human. This is because they don’t tick off the Refusal To Accept (RTA) checklist, which outlines across-the-board prerequisites. Meeting the RTA requirements simply means your device is worthy of an FDA review and has a realistic chance of being cleared.

7. Misunderstanding the point of a 510K submission

The 510 (k) has evolved quite remarkably over the years. Some time back, it was an endless series of paperwork submissions; now, it’s a streamlined affair that makes maximum use of mainstream contemporary technology. In all that, one thing remains the same: the purpose of the 510K, which is clearance through association or clearance for devices similar to other previously cleared devices.

Failure to understand that can have you wondering why the FDA is hard on you. As stated above, you should have a predicate device at the ready or even model your device on an existing one. That is not to say you should shy from being creative. However, if you want it easy with the FDA, you have to make it easy for them first.

Endnote

If you have been struggling to meet the requirements for a 510K clearance, you’re in good company. The process requires time, manpower, data, and a ton of resilience. It doesn’t have to be a hassle, though. By avoiding the above mistakes, you can massively simplify the process and speed up the review process.

Business

Ipsos Helps Brands Understand How They Get Customer Experience Wrong & Why It’s Costing Them Millions

Published

4 weeks ago

June 26, 2026

Matthew Wiles

For brands looking to succeed in the modern business ecosystem, the customer experience (CX) is not something companies can afford to ignore. CX is a direct driver of revenue, loyalty, and growth for organizations.

Ipsos, one of the world’s leading market research firms, helps brands understand that failing to focus on the customer experience can lead to lost sales, which in turn can translate to not only millions in lost revenue but also lost trust and credibility in the market.

How brands still get CX wrong

“The customer decision and desire to do business with brands directly affect the bottom line,” says Brad Christian, Chief Commercial Officer at Ipsos – Experience Practice.

Customer experience may sound like a simple concept, but many brands still get it wrong. CX goes beyond surveys and feedback. Leaders who fail to connect feedback in a meaningful way to goals such as retention, repeat visits or purchases, advocacy, and operational performance fail to deliver on their service promises. The emotional and functional disconnect can spell trouble for brands. The most polished advertising campaigns cannot make up for a frustrating customer interaction or a promise that a business cannot fulfill.

According to Ipsos’s internal research, many customers today see service as too automated and impersonal. More than half report that their experience is worse than promised.

These findings don’t just result in disappointed buyers. They result in lost customers, negative feedback, and a long-term impact on the business as a whole.

“Brands have to manage the entire customer experience across each and every touchpoint,” explains Christian.

Poor CX can be expensive

Executives can often underestimate how expensive a history of poor CX can be. Global losses can reach into the billions while leaders wonder what went wrong. In an age of rapid social media communication, a single negative interaction can spell disaster for a company, leading to reduced customer spending or the entire loss of its most loyal customers.

Those losses are not just reflected in lost revenue, however. Customer acquisition and marketing dollars can also be lost as companies continue to spend money trying to retain their customer base, often skipping right over the experience part of retention.

Poor customer experience can be a deep operating problem that creates a domino effect, decimating businesses from the inside out. These poor experiences can impact not only present and future customer acquisition but also business leaders and employees.

CX matters more in today’s business landscape

The customer experience has always mattered, but it may matter more to brands trying to make it in a modern, ultra-competitive, digitally-driven business landscape. Good experiences encourage repeat purchases, boost loyalty, and increase the likelihood that customers will go online and recommend a brand to others.

“Customer experience isn’t an isolated function,” says Christian. “It’s ‌part of a larger system that ensures that brands measure and manage customer experience data and then act on that data to drive action where customer experience gaps exist.”

Brands also have to seek to understand today’s customers, who expect experiences that are seamless, authentic, and relevant. As more and more companies hop on the automation train, they will want to reassure their customers that the human element that many people consider important still exists.

At Ipsos, six drivers of strong customer relationships form the bedrock of the company’s CX platform, something that they refer to as the “Forces of CX”: certainty, fair treatment, control, status, belonging, and enjoyment.

Customers want to feel that if they have an issue with a brand, it will be handled and that their concerns will be understood. They don’t want the customer experience to feel like a battleground; they want it to feel fair and human.

“Customer experience isn’t just a nicer experience,” says Christian. “It ties directly to specific financial outcomes, whether that be increased sales, greater market share, or stronger brand loyalty.”

How Ipsos helps businesses deliver customer experiences that matter

Ipsos turns customer feedback into reliable, actionable, decision-ready information. The company goes beyond simple satisfaction metrics and implements voice-of-the-customer programs, journey analytics, relationship feedback, and quality research.

“Brands don’t just need data,” Christian says. “They need measurements as to how they are delivering on their brand promise and predictive modeling to tie financial performance measures to those measures to help them determine where to invest to maximize the customer experience and understand what financial impact those investments might deliver for the business.”

Ipsos measures the interactions that matter ‌most and shows brands how each interaction can affect retention, share of spend, and efficiency. For brands that are trying to reduce the guesswork behind CX, Ipsos helps them move beyond cosmetic fixes to achieve real, meaningful change.

Customer expectations can shift on a dime, influenced by society, social media, and even changing trends. Ipsos helps brands meet those rapidly changing customer expectations with hard evidence and comprehensive metrics.

Today’s brands need to understand how to get the customer experience right. Ipsos has the insights needed to drive home the deep importance of CX in today’s marketplace.