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

What to Look for in an Enterprise Webcasting Solution

Published

4 days ago

September 12, 2025

Matthew Wiles

The modern workplace doesn’t stand still. Teams are global, employees are remote, and companies must communicate faster and at scale. That’s why enterprise webcasting has gone from a niche tool to an essential part of internal communication strategies.

Reliability is the starting point when broadcasting to hundreds or thousands of employees, stakeholders, or partners. The platform you choose needs to deliver more than a stable video feed; it must offer security, accessibility, scalability, and real engagement.

For enterprises navigating this decision, here’s what to consider before committing to a webcasting platform.

Scale and Performance Matter More Than You Think

It’s one thing to host a video call with your immediate team. It’s another to run a high-stakes webcast for your entire global workforce. Enterprise webcasting means reaching large, often geographically dispersed audiences, sometimes tens of thousands of people at once. And when that’s the case, performance isn’t negotiable.

Your platform should offer proven scalability with minimal lag, buffering, or outage risk. Many organizations underestimate the bandwidth and technical infrastructure needed to deliver seamless webcasting at scale. Look for solutions that utilize global content delivery networks (CDNs) and redundant systems to guarantee smooth streaming, regardless of your viewers’ location.

The reality is, your message only lands if the technology holds up under pressure.

Security Isn’t Optional

In a world of growing cyber risks and data privacy concerns, security must be front and center, especially for enterprise webcasts. Not every message is meant for public ears, from internal town halls to sensitive investor briefings.

Leading webcasting platforms provide enterprise-grade security features like encrypted streams, password protection, login authentication, and customizable access controls. Depending on your industry, you may also need to meet specific regulatory requirements for data protection and compliance.

Ultimately, your webcasting solution should provide peace of mind, knowing that confidential information stays where it belongs.

User Experience Makes or Breaks Engagement

Let’s face it: no one wants to wrestle with clunky software minutes before a big company update. The best webcasting platforms make life easy for both presenters and attendees.

Intuitive interfaces and simplified workflows reduce stress and help presenters focus on delivering the message. The process should be frictionless for attendees, with one-click access, mobile compatibility, and no need for complicated installations.

But accessibility isn’t just technical, it’s also about inclusivity. Your platform should offer features like captions, translations, or on-demand playback options to ensure your workforce can engage with the content.

Because if people can’t easily join or follow along, your webcast risks becoming background noise.

Engagement is More Than Just Showing Up

In enterprise settings, communication can’t be one-way. True engagement requires interaction.

Modern webcasting solutions offer features like real-time Q&A, live polls, and chat functions to turn passive viewers into active participants. These elements keep audiences focused and create opportunities for meaningful feedback.

Especially for company-wide meetings or virtual events covering important updates, giving employees a voice makes the experience feel collaborative, not just another broadcast.

Data and Insights Drive Improvement

One of the most overlooked aspects of enterprise webcasting is analytics. But without data, it’s impossible to measure success or spot opportunities for improvement.

Look for platforms that provide detailed reporting, including attendance metrics, engagement rates, audience locations, and performance benchmarks. Over time, these insights help refine your communication strategy, adjusting formats, reworking content, or targeting specific groups with follow-up resources.

The more visibility you have into how people interact with your webcasts, the better equipped you are to make those events impactful.

Flexibility for Different Event Types

Not all webcasts are created equal. Some are formal, high-production events with large audiences. Others are more casual, interactive sessions for smaller groups.

The platform you choose should give you the flexibility to manage both scenarios. Whether you’re hosting a polished executive briefing, a technical product demonstration, or a virtual town hall, the tools should scale to fit your needs, without requiring entirely different systems or workflows.

Many providers also offer managed services for high-profile events, giving you access to technical experts who handle the backend so your team can focus on the message.

Final Thoughts

Webcasting has become a critical tool for modern businesses, but choosing the right platform requires more than just comparing price tags. It’s about finding a solution that delivers reliability, security, engagement, and scalability while making the process simple for both your team and your audience.

With enterprise webcasting, companies can ensure their most important messages are delivered securely and at scale, whether to employees down the hall or stakeholders around the globe.