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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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Business

Why Multi-Province Payroll Compliance Is the Hidden Challenge Canadian SMBs Face and How Folks Solves It

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Photo courtesy of: Folks

Byline: Shem Albert

Running payroll in Canada can feel like crossing a country stitched from many different fabrics. Each province weaves its own pattern of tax rules, leave policies, and benefit requirements, creating a landscape where a single misstep can ripple through every paycheck. For small and mid-sized businesses, the challenge often remains hidden until growth pushes hiring beyond provincial borders or brings remote workers into the fold. What seems like a routine back-office task quickly becomes a test of accuracy, timing, and local knowledge. This is the gap that Folks set out to close, offering a way for employers to navigate Canada’s regulatory patchwork without slowing their momentum.

Provincial Rules Add Complexity

Canada’s payroll environment varies sharply by province. Federal rules set the foundation, but provincial tax rates, deductions, statutory leave entitlements, and benefit premiums add layers of complexity that employers must monitor carefully. Small and mid-sized businesses with staff across provinces or remote employees face different tax tables, reporting deadlines, and leave calculations that directly affect pay accuracy and remittance schedules.

Folks built its payroll module to address these differences. The platform calculates the correct provincial tax rates and deductions for each employee, applying updates automatically so employers avoid misapplied withholdings or late filings. Multi-location tax management allows a company with workers in Ontario, Quebec, or several other provinces to process payroll without creating separate accounts for each jurisdiction. Bilingual functionality in English and French and secure Canadian data hosting support compliance while keeping employee records accessible across language and regional boundaries.

Unified Records Improve Accuracy

Payroll errors often stem from mismatched employee data. Changes in pay rates, banking details, or benefits eligibility may not align between HR and finance systems, creating incorrect deductions or delayed payments. Smaller teams juggling separate platforms spend valuable hours reconciling information instead of focusing on strategic work.

Folks resolves these issues by combining HR and payroll in one platform. Updates to wages, hours, or tax information entered on the HR side flow directly into payroll without re-entry. This single, verified record strengthens the accuracy of every payroll run and ensures employees receive the correct pay and deductions. By removing the need for repetitive administrative work, HR staff can redirect their time to tasks that support growth and employee engagement.

Automation Keeps Provinces in Step

Each province sets its own requirements for holiday pay, pay frequency, and statutory benefits, making manual calculations both time-consuming and error-prone. Businesses that expand or hire remote employees must keep pace with shifting provincial regulations or risk penalties and audit issues.

Folks address these demands with automation designed for Canada’s regulatory landscape. Pay statements, deduction calculations, and custom pay schedules follow the applicable provincial rules without extra configuration. The system’s automated updates mean that a company hiring staff in British Columbia or Quebec can meet local payroll standards without adding new layers of setup or monitoring. Employers gain the ability to expand into new regions while maintaining accurate, on-time pay.

Reporting Strengthens Compliance

Changing tax rates and reporting requirements require ongoing attention from HR and finance teams. Companies that rely on disconnected systems risk missing a provincial update or submitting incorrect remittances, which can lead to fines and interest charges.

Folks provides detailed reporting tools that compile payroll, deductions, and benefits information across all locations. Employers can generate clear remittance and deduction summaries, simplifying the process of meeting provincial filing requirements. For organizations that want additional guidance, Folks also offers a payroll management service that brings in-house specialists to assist with configuration, compliance, and regular updates. These reporting features help companies stay audit-ready and avoid costly compliance gaps.

Scalable Payroll for Expanding Businesses

Many small businesses begin in a single province, where local tax and payroll demands can be learned over time. Growth into new provinces or the decision to hire remote staff adds a level of complexity that manual processes cannot handle efficiently. Errors multiply, compliance risks rise, and payroll teams spend more time correcting mistakes than supporting expansion plans.

Folks provides payroll that scales with company growth. Provincial tax logic, automated deductions, bilingual support, and secure Canadian data storage are built directly into the platform. By maintaining an accurate employee record and applying province-specific rules automatically, the system allows Canadian SMBs to expand with fewer administrative surprises and more predictable payroll operations. Companies gain the stability of compliant payroll across provinces while controlling the time and costs that typically accompany multi-jurisdiction growth.

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