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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

Robert DeFalco Realty Leads the Way with Strategic Expansion and Philanthropy

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Robert DeFalco, the visionary founder and Owner/Operator of Robert DeFalco Realty, cemented his reputation as a huge force in the real estate industry. His firm, recognized as the #1 real estate company in Staten Island, embarked on a significant expansion this year, solidifying its status as a comprehensive hub for real estate services in New York and New Jersey.

Strategic Growth and New Partnerships

This growth involves not only a physical expansion, but also a strategic partnership with Think Mortgage, a prominent mortgage firm with a strong presence in Brooklyn and Staten Island. The collaboration aligns perfectly with DeFalco’s vision of providing seamless and integrated real estate transactions.

“We are creating a holistic experience,” stated DeFalco.

By partnering with Think Mortgage, Robert DeFalco Realty ensures clients can find their ideal home and secure the best possible mortgage rates, simplifying the process into a smooth journey from start to finish — all in one building.

Comprehensive Services Under One Roof

The firm moved to a new location in Brooklyn, occupying an entire corner block to house its operations. The expansion ensures that clients can access all necessary services under one roof, including real estate and mortgage services, in-house title services, legal expertise, and more. The move underscores DeFalco’s commitment to providing unparalleled convenience for clients.

“We are creating a synergy where all real estate needs are met promptly and professionally, right here,” added DeFalco.

A Legacy of Philanthropy

Beyond his professional achievements, DeFalco is renowned for his philanthropic efforts. He believes in the responsibility of businesses to give back to their communities. Under his leadership, Robert DeFalco Realty is a leading sponsor for the Making Strides Against Breast Cancer walk, raising substantial funds annually.

In 2019, the Emergency Children’s Help Organization honored DeFalco for his significant contributions, recognizing him with the Man of the Year Award. His dedication to philanthropy also earned him the Service and Dedication Award from the Juvenile Diabetes Research Foundation in 2022.

Community Engagement and Support

Robert DeFalco Realty’s commitment to philanthropy extends to various community events and local charities. The firm supports a wide range of organizations, including the American Cancer Society, City Harvest, Monmouth University, St. Peters High School, and many more. Their efforts make a substantial positive impact, with total donations surpassing $1,000,000.

Most recently, DeFalco attended and sponsored the ECHO Foundation, GRACE Foundation, and Tunnel to Towers events in various capacities.

Looking Forward

With its recent expansion and continued commitment to comprehensive real estate services, Robert DeFalco Realty reaffirms its position as the premier one-stop real estate shop in the northeastern region. The firm continues to uphold its foundational philosophy of treating people well, a mantra that has guided its operations since its inception in 1987 and continues to inspire its growth and innovation today.

About Robert DeFalco

Robert DeFalco Realty was founded in 1987 by Robert DeFalco, a real estate Broker/Owner who wanted to help families achieve their dream of homeownership. Through the philosophy ‘Treat People Well,’ Robert DeFalco has grown into a successful real estate agency led by a professional team of highly motivated real estate associates with experience in residential, commercial, and new real estate development. For more information, please visit https://www.defalcorealty.com/ 

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