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

Retire Smart, Save More: How MDRN’s Virtual Planning Model Can Slash Retirement Costs

Published

3 days ago

October 8, 2024

Rosario Farell

The media is calling it a “retirement crisis.” Millions of Americans are arriving at retirement age woefully unprepared.

Some studies suggest that 45 percent of the Baby Boomers have no retirement savings, while 28 percent of those who have started saving have less than $100,000 put away. Consequently, many Americans now living in retirement or approaching that season are looking for ways to cut back on their expenses.

Aaron Cirksena, founder and CEO of MDRN Capital, has a solution for those looking to retire smart and save more. His firm’s completely virtual model increases retirees’ spending power by decreasing the fees associated with retirement planning.

“Our unique approach to providing retirement planning services allows our clients to experience significant savings when compared with the traditional model of investment management and retirement planning,” Cirksena shares. “When we did away with the overhead expenses that stem from operating a brick-and-mortar office, we were able to create a fee solution for our clients that is lower than the typical advisor. On average, our fees on the entire client portfolio tend to run 30 to 40 percent lower than the typical advisor operating under a conventional model. Additionally, we can provide services like estate planning, tax planning, and tax preparation at no additional cost.”

MDRN Capital is revolutionizing retirement planning by offering a comprehensive range of services, including income planning, investment management, tax planning, healthcare, and estate planning, in a setting that exceeds the efficiency and effectiveness traditional providers are able to offer. Unlike traditional firms, MDRN Capital leverages the power of digital tools to deliver comprehensive services without the need for in-person meetings, allowing clients to enjoy their retirement while their financial needs are expertly managed.

“My goal with MDRN Capital was creating a completely virtual firm that could more efficiently provide the convenience clients wanted while also meeting their ongoing investment needs,” Cirksena shares. “MDRN Capital’s virtual model empowers an environment in which we could serve our clients with less costs to the firm and pass the savings on to them.”

Financial planning for the new normal

MDRN Capital’s innovative approach to retirement advising emerged as a result of Cirksena’s experience during the COVID-19 pandemic. Due to social distancing, advising during the pandemic shifted to virtual appointments. When social distancing was no longer necessary, Cirksena expected his clients would resume their pre-pandemic patterns. He was wrong.

“My clients let me know they preferred the comfort and convenience of virtual meetings to the hassles associated with having in-office meetings,” Cirksena says. “They didn’t miss sitting in traffic and searching for parking spaces, and I couldn’t blame them. Even the clients who lived only a few minutes away decided they would rather meet via Zoom than have a face-to-face meeting in our nice Class-A office space.”

MDRN Capital was designed to meet the client expectations that emerged during Covid. By leveraging technology to take his services to his clients rather than expecting them to come to him, Cirksena made advising more convenient and more cost-effective at the same time.

Financial savings for struggling retirees

Recent studies show the high inflation the US has been experiencing has a larger than average impact on many retirees. In response, many are looking to tighten their belts by cutting back on spending, but reducing the fees associated with retirement accounts is something few consider.

“For retirees, lower gas and grocery costs are certainly helpful,” Cirksena says. “However, cutting their investment management costs in half puts dramatically more money in their pocket over time than lower prices on goods ever could.”

To understand the impact MDRN Capital’s approach can have on retirees, consider that $250,000 earning seven percent over 20 years will grow to $967,421.12. Factor in a 1 percent fee, and growth is limited to $801,783.87, but raising the fee to 2 percent causes earnings to fall to $721,034.70.

Cirksena points to his industry’s failure to embrace modern technology as one reason why investment fees remain high.

“Unlike many industries that have used and adopted technology for decades to help lower costs and make services more efficient, the financial services sector has lagged behind,” he explains. “Many firms continue to incur unnecessary overhead and expenses, which their clients pay for in the form of elevated fees.”

The virtual investment environment Cirksena has created moves retirement planning into the future. It provides a financial service experience that is convenient, comfortable, and efficient while also ensuring that none of its clients’ investment potential is wasted on unnece