510kfda
510(k) FDA Clearance Simplified

Be it X-ray generators, imaging products or software, or orthopedic external fixators, it is mandatory for medical device manufacturers to receive 510(k) clearance from the food and drug administration (FDA) to market their newly manufactured products in the U.S. The 510(k) submission process can be overwhelming to most manufacturers as they must determine the right type of 510(k) and select the best method to prove the substantial equivalence (SE) of their device. When it comes to adhering to the stringent medical device regulations and getting a new medical device approved by the FDA, the most common question that crosses a manufacturer’s mind is “where to get started?” 510kfda—an expert 510(k) FDA consulting firm with more than 30 years of experience—has an apt solution to this problem. 510kfda has carried out the 510(k) submission process for a variety of devices and has in-depth knowledge of the FDA’s requirements. With a proven track record of clearing medical devices, 510kfda is equipped to pull all the missing pieces together to help medical device manufacturers obtain the FDA 510(k) clearance with ease.

510kfda guides manufacturers through the 510(k) submission process, starting with gathering all of their technical documents—all 21 sections, primarily the device description, engineering drawings, and test reports. Depending on the nature of the device (electronic/software, sterilization requirements and shelf life, biocompatibility, electromagnetic compatibility, electrical safety, and more), the company helps clients determine the tests they need to perform and produce detailed reports for the FDA review. The company also assists them in coordinating the clinical evaluation of the device and conducting performance testing. Once all of the descriptive documents and test reports are assembled, 510kfda writes a comparison between the client's new device and a similar device (predicate device) that FDA has already cleared. “Our goal is to prove that the new device is substantially equivalent to the predicate device,” notes W. Lee Strong, Quality Systems Manager at 510kfda. The company then packages these documents, approximately 20 chapters, to present to the FDA. Finally, 510kfda works closely with the FDA review panel to ensure that the submitted documents contain all the required information while answering as many questions from the FDA as possible.

We can help translate the FDA terminology into a simple and clearer working language for our clients to act on as they plan their procedures and design their systems

Typically, it takes four to six months to receive 510(k) clearance from the FDA with a unique ‘K number’ that can be validated in public records online. 510kfda also helps clients register their manufacturing establishment with the FDA and prepare for inspections.

“One of the primary challenges our clients face is to comprehend the FDA’s requirements that are written in complex terms. We can help translate the FDA terminology into a simple and clearer working language for our clients to act on as they plan their procedures and design their systems,” says Strong. Manufacturers need to transition from a ‘research’ to a ‘regulatory’ mindset to market a new device, demonstrate its value in the marketplace, and prove it safe and effective for its intended use. This transition calls for adopting all the disciplines of structured product development. With over 20 years of experience as a software developer, Strong has learned to apply structured processes to the design and development of computer programs, which are often a part of modern medical devices. He opines that software continues to be one of the most challenging technologies to regulate and requires the developer to maintain highly stringent design controls, trace every requirement through the system, and validate the product.

510kfda has cleared a range of petitions—from x-radiation generators and dental imaging products to long-established denture base resins and cutting-edge CAD/CAM 3D “additive printing” devices. Powered by dedicated staff with ingrained industry knowledge, the company facilitates the clearance of clients’ medical devices for sale in the U.S.

510kfda understands that clients must have a quality management system (QMS) in place as it helps describe their standard operating procedures, records, and reports that are auditable and verifiable for maintaining compliance with the code of federal regulations. To this end, the company intends to offer longer-term quality management service to its clients in the near future. With sights set on a promising future, 510kfda aims to add more support for post-market quality management.