According to the firm’s founding attorney, Nick Oberheiden, PhD, “The FDA’s 510k submission process provides a pathway for companies to begin marketing eligible devices without securing premarket approval. However, making a compliant 510k submission can be challenging, and it is imperative that companies ensure their devices’ eligibility before making these submissions.” He continues, “Among other things, this includes demonstrating safety and effectiveness that are ‘substantially equivalent’ to a similar legally marketed device.”
As explained on the FDA’s website, when making 510k submissions, companies “must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.” Dr. Oberheiden says the firm’s attorneys are prepared to assist clients with this process—including (but not limited to) confirming the selection of an appropriate predicate device. “From analyzing performance data to analyzing device components themselves, there are several factors involved in determining when a device can be used for comparison as a substantially equivalent device. Our attorneys are intimately familiar with the FDA’s guidance on these issues and are fully prepared to help clients navigate this cost-effective regulatory pathway.”
The 510k premarket notification process is available for use with qualifying Class I, Class II, and Class III devices intended for human use in the United States. Device manufacturers, foreign exporters, specification developers, repackagers, and relabelers may all be required to go through the FDA clearance process before selling devices domestically. If the FDA determines that a company has improperly used the 510k process or marketed a device in the U.S. without going through the 510k process, this can lead to a mandatory market withdrawal and other penalties under the Food, Drug, and Cosmetic Act (FDC Act).
As a result, for companies seeking to use the 510k process rather than the FDA’s premarket approval or de novo classification process, proper device classification is essential. When assessing both general eligibility for the 510k process and substantial equivalence for a new device, companies must consider device type, intended use, technological characteristics, commercial distribution, and patient safety—among various other factors. Dr. Oberheiden says that the firm’s 510k compliance attorneys are able to assist U.S. medical device companies, foreign manufacturers, and other clients not only with assessing premarket notification eligibility, but also with assessing and pursuing other pathways as necessary.
Oberheiden P.C.’s attorneys are able to assist clients with other FDA-related compliance and enforcement matters as well. Dr. Oberheiden says, “Whether your company is seeking to establish substantial equivalence with a previously cleared device or you have other questions about FDA compliance, our firm can provide assistance with establishing and maintaining compliance on an ongoing basis. For many companies, making a premarket submission is not a one-time event. We are seeking to establish long-term relationships with industry-leading clients to whom we can offer our advice, insights, and representation on an ongoing basis.”
Dr. Oberheiden lists conducting clinical trials, seeking marketing authorization, navigating the FDA review process, undergoing FDA facility inspections, and interpreting FDA guidance documents as just some of the other services the firm offers. “While we are now promoting our 510k submission services, we have a long track record of helping clients both avoid and withstand FDA scrutiny.” He continues, “By providing both compliance and defense representation, we are able to offer our clients insights guided by the FDA’s enforcement priorities, and we are able to help ensure that our clients have the procedures, protocols, and documentation required to demonstrate compliance to the FDA when necessary.”
The firm offers complimentary initial consultations, and Dr. Oberheiden encourages business owners and executives who have questions to schedule an appointment. “If anyone has questions about their company’s next steps with the FDA regarding any Class I device, Class II device, or Class III device, we invite them to get in touch to learn more about how we can help.”
Nick Oberheiden, Founding Attorney, 888-680-1745 (Office)
Attorney Advertising – Oberheiden, P.C., is an FDA compliance and defense law firm headquartered in Houston, TX with a nationwide network of senior attorneys and consultants. The firm’s FDA lawyers are available to assist clients throughout the United States and worldwide with the 510k submission process. The firm’s addresses and contact information can be found at www.federal-lawyer.com/our-locations.
Media Contact
Company Name: Oberheiden, P.C
Contact Person: Nick Oberheiden, Founding Attorney
Phone: 888-680-1745
Country: United States
Website: https://federal-lawyer.com/healthcare/fda/510k-compliance