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

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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.

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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Remote Professionals Getting More Value for Their Work Thanks to Borderless Banking

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Not too long ago, the idea of working remotely from an island in Thailand or a co-working space in Berlin sounded like the kind of fantasy only tech moguls or backpacking freelancers could afford. 

Fast forward to today, and it’s as good as a global reality. Millions of professionals have cut the cord from traditional office life in exchange for flexibility, freedom, and a work-life balance that fits their personal rhythm and not their employer’s timezone.

However, as remote work has reshaped how people earn a living, it’s also pointed out the existing limits to most of the world’s financial systems. Traditional banking simply wasn’t built for a workforce that’s always on the move, operating in multiple currencies, and getting paid across borders. 

Thankfully, that’s where borderless banking like Black Banx have proven vital, and has quietly transformed the way money is managed for people vacationing and working overseas alike.

The Rise of the Remote Work Economy

Remote work isn’t just a pandemic-era trend that faded with Zoom fatigue—it’s become a defining feature of the modern workforce. A recent survey revealed that over 39% of Gen Z and Millennials planned to live and work abroad for extended periods this year, many staying six months or more in a single location. That’s beyond a short trip, and can be considered as good as a sabbatical with a substantial lifestyle shift.

According to recent estimates, the digital nomad economy now also contributes as much as US$787 billion annually to the global economy. And this isn’t just entry-level gig work. A third of digital nomads earn between US$100,000 and US$250,000, while another third take in US$50,000 to US$100,000 annually. 

It is indeed evident that the manner in which many make a living has changed. Unfortunately, most financial systems haven’t kept up.

Where Traditional Banks Are Still Falling Short

For those who have ever tried to open a bank account abroad or receive payment from a foreign client, they already know the drill: the paperwork is endless, delays are frustrating, and the fees? So much to do, even for the smallest amounts of money.

Just to name few of the hurdles remote workers still face with conventional banking:

  • Account setup restrictions: Need proof of residence, tax IDs, or a local job offer—things many digital nomads simply don’t have.
  • Slow international transfers: Payments can take days to process, which is a nightmare when rent’s due.
  • High foreign exchange fees: Currency conversions often come with steep, hidden costs.
  • Limited multi-currency support: Most banks still force users to operate in a single currency, making financial planning chaotic at best.

And perhaps most tellingly, many banks have digitized their operations but haven’t personalized their services. According to Accenture’s 2025 Banking Trends Report, while digital transformation has improved efficiency, it often sacrifices the customer experience. That’s not great news for people who live outside the lines.

Borderless Banking for Professionals Across the Globe

The concept of borderless banking goes far beyond wiring money internationally. Fundamentally, it’s also about being able to eliminate the friction between people and their money, no matter where they are in the world, and maintaining an ecosystem where geography, bureaucracy, and currency don’t stand in the way of financial freedom.

A working example of this is Black Banx, a Toronto-based fintech founded by German billionaire Michael Gastauer. Since launching globally in 2015, it has grown to serve over 78 million clients in 180+ countries as of Q1 2025, proof that people take to digital banking solutions when it is accessible, affordable, and is useful in just about any locale.

In the first three months of this year, Black Banx had also earned US$4.3 billion in revenue and US$1.6 billion in pre-tax profit, more than double from the same quarter the previous year and showing it has consistently delivered tangible value to global customers—remote professionals included

How Borderless Banking Maximizes Value for Remote Workers

1. Instant Account Access—No Strings Attached

The times of hunting down local branches or collecting endless documents just to open an account are finished. With borderless banks, users can open an account in minutes using just a photo ID—no proof of address or income required. That’s a lifesaver for anyone living outside their passport country or hopping from one location to another.

2. Multi-Currency Mastery

Managing money in multiple currencies used to mean juggling several accounts—or worse, losing money on conversions. Borderless platforms like Black Banx support 28 FIAT currencies and allow real-time currency conversions at competitive rates. That means remote workers can:

  • Invoice clients in one currency
  • Spend or save in another
  • Hedge against local currency fluctuations
  • Avoid excessive conversion fees altogether

3. Seamless, Real-Time Global Payments

Getting paid late, or paying others late, isn’t just inconvenient; it can damage relationships and disrupt your cash flow. With real-time payment support, remote workers can receive funds instantly, no matter where their clients are. This is particularly valuable for freelancers and entrepreneurs juggling multiple contracts across time zones.

Plus, bulk payment features and API integration streamline processes for those running teams or businesses.

4. Built-In Crypto Options

It isn’t surprising that many digital nomads are already deep into crypto. Whether it’s for investment, faster transactions, or avoiding traditional finance red tape, crypto is becoming essential.

Since 2016, Black Banx has allowed users to send, receive, and convert crypto (like BTC and ETH) within their accounts. That integration saves users from having to manage separate crypto wallets, and adds another layer of flexibility to their financial toolkit.

5. Secure Transactions

Remote workers often log in to work from cafés, coworking spaces, and airports, to name a few. Of course, this flexibility of being able to work almost anywhere should never come at the cost of security. Borderless banks like Black Banx use end-to-end encryption, AI fraud detection, and two-factor authentication to keep accounts safe from risky elements.

Financial Freedom, Not Just Convenience

Perhaps the most overlooked benefit of borderless banking is the freedom it provides. Not just to access money, but to fully participate in the global economy. For millions of professionals in underbanked regions like Africa, Latin America, Southeast Asia, borderless banking has become a gateway to financial inclusion and a way to take on opportunities that typically wouldn’t be available to them if not remote.

By removing barriers to entry, platforms like Black Banx empower underserved individuals to both take control of their finances and increase their earning power by working with companies from higher paying markets. This democratization of finance isn’t just good for individuals, it’s good for the global economy as a whole.

As Black Banx CEO Michael Gastauer put it: “Our multi-currency solutions enable businesses to tap into global talent without worrying about payment complexities. We make cross-border transactions as seamless as local ones.”

The Road Ahead

By 2030, the number of digital nomads worldwide is expected to soar past 60 million, according to the Forbes Technology Council. That means tens of millions of workers will be navigating foreign currencies, time zones, and financial systems—all while expecting the same seamless experience they’d get at home.

Indeed, remote professionals aren’t just looking for places to work—they’re looking for systems that work for them. In a lifestyle built on flexibility, traditional banking is proving too rigid, too slow, and too expensive.

Borderless banking services like those offered by the likes of Black Banx, on the other hand, offer exactly what today’s global workforce needs: instant access, multi-currency support, real-time payments, crypto integration, and enterprise-level security—all in a streamlined experience.

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