Business

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

Published

2 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

Turning Tragedy into Triumph Through Walking With Anthony

Published

1 week ago

April 18, 2024

Rosario Farell

On the morning of February 6, 2010, Anthony Purcell took a moment to admire the churning surf before plunging into the waves off Miami Beach. Though he had made the dive numerous times before, that morning was destined to be different when he crashed into a hidden sandbar, sustaining bruises to his C5 and C6 vertebrae and breaking his neck.

“I was completely submerged and unable to rise to the surface,” Purcell recalls. “Fortunately, my cousin Bernie saw what was happening and came to my rescue. He saved my life, but things would never be the same after that dive.”

Like thousands of others who are confronted with a spinal cord injury (SCI), Purcell plunged headlong into long months of hopelessness and despair. Eventually, however, he learned to turn personal tragedy into triumph as he reached out to fellow SCI victims by launching Walking With Anthony.

Living with SCI: the first dark days

Initial rehabilitation for those with SCIs takes an average of three to six months, during which time they must relearn hundreds of fundamental skills and adjust to what feels like an entirely new body. Unfortunately, after 21 days, Purcell’s insurance stopped paying for this essential treatment, even though he had made only minimal improvement in such a short time.

“Insurance companies cover rehab costs for people with back injuries, but not for people with spinal cord injuries,” explains Purcell. “We were practically thrown to the curb. At that time, I was so immobile that I couldn’t even raise my arms to feed myself.”

Instead of giving up, Purcell’s mother chose to battle his SCI with long-term rehab. She enrolled Purcell in Project Walk, a rehabilitation facility located in Carlsbad, California, but one that came with an annual cost of over $100,000.

“My parents paid for rehabilitation treatment for over three years,” says Purcell. “Throughout that time, they taught me the importance of patience, compassion, and unconditional love.”

Yet despite his family’s support, Purcell still struggled. “Those were dark days when I couldn’t bring myself to accept the bleak prognosis ahead of me,” he says. “I faced life in a wheelchair and the never-ending struggle for healthcare access, coverage, and advocacy. I hit my share of low points, and there were times when I seriously contemplated giving up on life altogether.”

Purcell finds a new purpose in helping others with SCIs

After long months of depression and self-doubt, Purcell’s mother determined it was time for her son to find purpose beyond rehabilitation.

“My mom suggested I start Walking With Anthony to show people with spinal cord injuries that they were not alone,” Purcell remarks. “When I began to focus on other people besides myself, I realized that people all around the world with spinal cord injuries were suffering because of restrictions on coverage and healthcare access. The question that plagued me most was, ‘What about the people with spinal cord injuries who cannot afford the cost of rehabilitation?’ I had no idea how they were managing.”

Purcell and his mother knew they wanted to make a difference for other people with SCIs, starting with the creation of grants to help cover essentials like assistive technology and emergency finances. To date, they have helped over 100 SCI patients get back on their feet after suffering a similar life-altering accident.

Purcell demonstrates the power and necessity of rehab for people with SCIs

After targeted rehab, Purcell’s physical and mental health improved drastically. Today, he is able to care for himself, drive his own car, and has even returned to work.

“Thanks to my family’s financial and emotional support, I am making amazing physical improvement,” Purcell comments. “I mustered the strength to rebuild my life and even found the nerve to message Karen, a high school classmate I’d always had a thing for. We reconnected, our friendship evolved into love, and we tied the knot in 2017.”

After all that, Purcell found the drive to push toward one further personal triumph. He married but did not believe a family was in his future. Regardless of his remarkable progress, physicians told him biological children were not an option.

Despite being paralyzed from the chest down, Purcell continued to look for hope. Finally, Dr. Jesse Mills of UCLA Health’s Male Reproductive Medicine department assured Purcell and his wife that the right medical care and in vitro fertilization could make their dream of becoming parents a reality.

“Payton joined our family in the spring of 2023,” Purcell reports. “For so long, I believed my spinal cord injury had taken everything I cared about, but now I am grateful every day. I work to help other people with spinal cord injuries find the same joy and hope. We provide them with access to specialists, funding to pay for innovative treatments, and the desire to move forward with a focus on the future.”