A significant number of innovative medical technologies fall into FDA’s Class II classification, the vast majority of which require an FDA 510(k) submission. What exactly is a 510(k)? What types of products fall into the Class II, 510(k) category?


Grace Powers, principal consultant with Powers Regulatory Consulting, has 20 years of industry experience in medical devices including research and development. From her bio: “She has leadership experience with managing regulatory affairs responsibilities related to all pre- and post- marketing regulatory activities and submissions.  Her RA submission experience includes 510(k), Pre-Submissions, IDE, PMA, EU Technical Files and Design Dossiers.  She has also managed an International RA team which included Canadian licensing, TGA, Japan, China, Russia, Latin America and other country submissions.  Grace holds an BE in Biomedical Engineering from Vanderbilt University, an MS in Biomedical Engineering from UCLA and an MBA from Georgia Tech. She is RAC US, RAC Europe, and RAC Global certified.”


GCMI leans on Grace’s regulatory expertise frequently. She graciously shares her insights on the FDA 510(k) clearance requirements in the Q&A below.


Q: What is a 510(k) and what are the components of the document? 


A: “A 510(k) is a [type of] submission to FDA that contains technical information about a specific medical product or technology. It would include information about your medical device including indications for use, labeling and all testing protocols and data. Testing may include information about biocompatibility with the body, sterility and the packaging that keeps it sterile. For software and hardware elements, testing methods and data to include in a 510(k) are required to evaluate electrical and functional safety of a device.”


Q: What are the most common types of products that require a 510(k) submission?


A: “Typically, 510(k) products are the “middle level” of risk classification. FDA categorizes devices as Class I, II or III: low, moderate or high level risk to the patient and user.


“Examples of low level risk, Class I, devices include tongue depressors or toothbrushes or other more commodity type products. The majority of new medical devices and technologies that we think of fall into the Class II or 510(k) group. Class III high risk devices or technologies are life sustaining like a pacemaker or a novel material implant.


“Some typical 510(k) devices or technologies include catheter-based technologies and some orthopedic implants (dental, etc.). However, there are exceptions to every rule.”


Q: Where are the trickiest “hidden difficulties” in an FDA 510(k) submission?


A: “Having a strong, well-planned regulatory strategy for the predicate device is an area that can be challenging for medtech innovators and their teams. It’s not the most logical ‘system’ to compare your device to a predicate already on the market knowing those devices are not identical.


From our colleagues at Greenlight Guru, “A predicate device is a medical device that may be legally marketed in the U.S. and used as a point of comparison for new medical devices seeking approval through FDA’s 510(k) premarket clearance pathway.” 


“Understanding your predicate device is important to know how it will impact what you can say about yours and how you can compare yourself to it,” Grace says. 


“It appears when you’re comparing yourself to something on the market that technology would not continue to evolve because you’re showing how your product or technology is similar. You must have a thorough, clear understanding of the differences between a predicate and your own because you must show those characteristics do not negatively impact safety and effectiveness.


“For example: You may have a cardiovascular catheter with a known design and material. You believe the known design with a different material may produce a better product in your opinion. In that case you must still show the product of identical design but built from a new material will not increase risk without claiming that it is better.”


Q: What else should medtech innovators know about 510(k) submissions?


A: “Although they have less documentation reviews than cClass III PMA (pre-market approval) products, the FDA 510(k) submission and clearance process is much more than just filling out a form. A typical 510(k) submission includes at minimum 200 pages of technical information. That number increases significantly if there is a lot of testing or software and hardware involved.


“A traditional 510(k) submission has a 90-day stated review. This is the time that the FDA has the submission under review. However, if any information is missing or there are additional information requests from FDA, the clock stops and the applicant is expected to respond. Depending on the questions or information requested, that response can range from a couple of days to a couple of months. If there is a request for additional testing and data, that can add four to six months to the response time depending on the test. Getting it right the first time means investing more in project planning, design and development and verification and validation. It is always worth investing in the process and a proven team.”


GCMI thanks Grace for her time, insights and contributions to our customers’ success.


Our process

Our phase-gated design and development process leads innovators to a quality product while also generating the content necessary for regulatory submissions. Innovators can jump in at any point in our Phase Zero through Phase 5 process, though many actually discover that “backing up” to earlier stages may be advantageous in the long-run. We encourage all medtech innovators to talk to us wherever you may be in your project path.


Contact info@gcmiatl.com for a deeper dive into Grace’s insights or to learn more about our proven medical device design and development pathway.