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




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.


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.

The idea of Bigtime Daily landed this engineer cum journalist from a multi-national company to the digital avenue. Matthew brought life to this idea and rendered all that was necessary to create an interactive and attractive platform for the readers. Apart from managing the platform, he also contributes his expertise in business niche.

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Designing Secure Commercial Spaces Without Compromising Aesthetics




In the realm of commercial design, security and aesthetics often seem like opposing forces. Business owners and designers alike grapple with the challenge of creating spaces that not only captivate and inspire but also ensure the safety and security of assets and occupants. The good news is that integrating security features into commercial spaces without sacrificing visual appeal is entirely achievable. This blog post will delve into innovative design strategies that harmonise security with aesthetics, including a look at the best deadlocks for front doors in Australia, ensuring your commercial space is both beautiful and fortified.

Embracing Technology for Seamless Security

Modern technology offers a plethora of options for discreet yet effective security measures. For instance, advanced surveillance systems can be integrated into the architectural design in a way that they blend seamlessly with the environment. Smart locks and biometric access controls offer robust security without the clunky hardware, maintaining a sleek and modern aesthetic. Implementing these technologies not only elevates the security level of your commercial space but does so without disrupting its design flow.

Strategic Use of Materials and Design Elements

The choice of materials and design elements plays a crucial role in balancing security and aesthetics. High-strength materials such as tempered or laminated glass, for example, offer excellent security without compromising on the visual openness that glass provides. Similarly, incorporating natural barriers like decorative boulders or planters can serve as subtle physical deterrents while enhancing the space’s visual appeal.

Lighting: A Dual-Purpose Tool

Lighting is another powerful tool that serves both aesthetic and security purposes. Well-planned lighting can highlight architectural features and create a welcoming atmosphere while ensuring visibility and deterring unauthorised access after hours. Motion-sensor lighting, in particular, can be a discreet addition that enhances security without detracting from the design.

The Role of Deadlocks in Aesthetic Security

A critical aspect of securing any commercial space is the choice of locks, especially for front doors which are the primary entry and exit points. Deadlocks offer a high level of security, making them an essential feature for commercial spaces. However, selecting the right deadlock doesn’t mean you have to settle for a utilitarian look. Today, the market offers a variety of deadlock designs that complement any aesthetic, from modern minimalist to classic elegance. For those in Australia, choosing the best deadlocks for front doors involves considering both the security features and how the lock’s design integrates with your commercial space’s overall look.

Collaboration Between Security Experts and Designers

Achieving a balance between security and aesthetics often requires a collaborative approach. Security experts and interior designers need to work hand in hand from the early stages of the design process. This collaboration ensures that security measures are not afterthoughts but are integrated into the design in a way that complements the space’s aesthetic appeal.

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Designing secure commercial spaces without compromising aesthetics is not only possible but essential in today’s world. Remember, the goal is to integrate security seamlessly into the design, enhancing the user experience and ensuring peace of mind for both business owners and visitors. With thoughtful planning and collaboration, your commercial space can be a testament to the harmony that can exist between security and aesthetics.

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