Business

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

Published

3 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

Top 5 Virtual Assistant Companies to Watch in 2025

Published

2 weeks ago

January 23, 2025

Matthew Wiles

Running a successful business in today’s fast-paced world requires a sharp focus on growth, strategy, and efficiency. However, managing the day-to-day operations can often become overwhelming. That’s where virtual assistant (VA) companies come into play. These companies specialize in providing skilled professionals who can handle everything from administrative tasks to customer service, marketing, and beyond, allowing entrepreneurs and small business owners to focus on what they do best.

With so many VA companies on the market, choosing the right one can be a challenge. To help you navigate the options, we’ve compiled a list of the top 5 virtual assistant companies to watch in 2025. Whether you’re an entrepreneur, a startup founder, or a busy professional, these companies offer top-tier solutions to meet your needs.

1. Assist World – The Gold Standard in Virtual Assistance

At the top of our list is Assist World, a U.S.-based company renowned for its personalized approach to matching clients with virtual assistants. Assist World goes beyond the typical “one-size-fits-all” model by taking the time to understand your unique needs and connecting you with highly skilled VAs who align perfectly with your business goals.

What Makes Assist World Stand Out?

Personalized Matching: Assist World matches clients with virtual assistants based on their specific requirements, ensuring the right fit every time.
Comprehensive Onboarding Process: The company’s seamless onboarding process streamlines communication and ensures VAs hit the ground running.
Client Success Management: Dedicated client success managers oversee the relationship, providing ongoing support and ensuring smooth operations.
Flexibility and Scalability: Assist World caters to businesses of all sizes, offering flexible plans that can scale as your business grows.

Who Is It Best For?

Assist World is ideal for entrepreneurs and small-to-medium businesses seeking a reliable, high-quality VA service that delivers consistent results.

Pricing:

Pricing is customized based on your needs, making it accessible for a wide range of budgets. Schedule a free consultation to learn more.

2. Time Etc – Affordable and Efficient

If affordability is your priority, Time Etc is a strong contender. This VA company specializes in administrative tasks and offers services at competitive rates. With a team of experienced professionals, Time Etc focuses on helping clients boost productivity without breaking the bank.

Key Features:

Dedicated VAs with extensive experience.
Transparent pricing with no hidden fees.
Focused primarily on administrative and organizational tasks.

Who Is It Best For?

Time Etc is a great choice for solopreneurs and small businesses looking for cost-effective virtual assistance for basic tasks.

Pricing:

Plans start at $29 per hour, with discounts available for bulk hours.

3. Belay – A Leader in Remote Executive Assistance

For those in need of executive-level support, Belay is a premier option. This company specializes in matching clients with highly skilled remote assistants who can handle complex tasks such as calendar management, bookkeeping, and project coordination.

Key Features:

Focus on executive and specialized assistance.
Rigorous vetting process for VAs.
Excellent client support.

Who Is It Best For?

Belay is ideal for CEOs, executives, and high-level professionals who require top-tier assistance.

Pricing:

Premium services come at a higher price point, starting around $2,000 per month for part-time support (45 hours a month). For 85 hours a month, pricing sits around $3,800.

4. MyOutDesk – Virtual Assistants for Real Estate

Real estate professionals, take note: MyOutDesk is the go-to VA service for your industry. Specializing in real estate operations, MyOutDesk provides skilled VAs who can handle lead generation, transaction coordination, and CRM management.

Key Features:

Expertise in real estate processes.
Comprehensive training programs for VAs.
Proven track record with top real estate agents.

Who Is It Best For?

Realtors, brokers, and real estate teams looking to streamline their operations and focus on closing deals.

Pricing:

Pricing starts at $1,750 per month for full-time assistants.

5. Boldly – Premium Virtual Assistant Services

If you’re looking for high-quality, premium VA services, Boldly is worth considering. This company offers subscription-based plans that provide access to experienced VAs skilled in a variety of disciplines, including marketing, customer service, and project management.

Key Features:

Highly experienced professionals.
Flexible subscription plans.
Focus on long-term client relationships.

Who Is It Best For?

Businesses and individuals willing to invest in premium services for comprehensive support.

Pricing:

Plans start at $39 per hour, with monthly subscriptions available.

How to Choose the Right Virtual Assistant Company

When selecting a VA company, consider the following factors:

Your Business Needs: Identify the tasks you want to delegate and choose a company that specializes in those areas.
Budget: Assess how much you’re willing to invest in virtual assistance and find a provider that aligns with your budget.
Flexibility: Look for companies that offer scalable plans to grow with your business.
Support: Choose a company with excellent client support to ensure smooth communication and problem resolution.

Why Assist World Is the #1 Choice

While all the companies on this list offer excellent services, Assist World stands out for its personalized approach, exceptional client success management, and flexible solutions, and most importantly, their fair pricing. At Assist World, prices generally fall between $1,500 – $2,000 a month for a full-time dedicated executive assistant. With a proven track record of helping businesses thrive, Assist World is the ultimate partner for entrepreneurs and small businesses ready to scale efficiently and effectively.

Ready to take your business to the next level? Schedule a free consultation with Assist World today and discover the difference a high-quality virtual assistant can make.