About Us

FDA Consulting LLC specializes in regulatory and compliance related submission services to manufacturers, importers, and suppliers of medical devices. Our FDA Consultants are experts in medical device 510(k) submission to FDA for product approval. Our consultants got over 30 years of medical product experience, and familiar with FDA’s medical device product classifications. We are transparent and will make timely and effective regulatory submissions to the FDA for a fixed fee. We ensure to file appropriate notifications and filings for timely approval.

Since our FDA consultants got a long-standing relationship working with the FDA and a track record of success in 510(k) submissions and clearance, we are proud to assist our clients to successfully navigate the 510(k) submission process. As your FDA 510(k) consultant, some of the services that we provide include evaluating your medical device’s classification, perform GAP analysis, prepare the regulatory strategy, collect the necessary data, safety and performance test report and documentation to complete the 510(k) Submission. As your FDA 510(k) consultant, our goal is to remove the stress and burden of the 510(k) submission work from your shoulders by bringing regulatory and compliance skills, so that you get the desirable outcome from the U.S Food and Drug Administration (FDA) at the end of the submission process.

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Our Systems and Processes

FDA Consulting LLC has in place a highly defined systems, processes and templates that are constantly revised and refined to keep them up to date to meet the FDA’s Guidance and ever changing regulatory requirements. Our FDA 510(k) Consultants stay ahead in the regulatory environment by regularly keeping themselves abreast with FDA’s device specific regulations, Guidance documents and by participating in the FDA workshops, conference, and meetings.

Our People

Our FDA Consultants specialize in medical device registration and clearance for FDA regulatory compliance and the most common route to clearance in the United States is 510(k) Submissions. Our FDA Consultants deep knowledge about the FDA’s regulatory compliance requirements and extensive industry experience helps provide the most complete and insightful consulting service to our clients in all aspects of the regulatory processes for 510(k) Submissions, Pre-Sub/Q-Subs, Medical Device Master File (MAF); 513(g), De Novo, IDEs, and PMA submissions to the U.S FDA.

Our FDA 510(k) Consultants directly worked with the U.S. FDA or in the medical device industry and have a wealth of regulatory and compliance experience, most with over 30+ years of experience individually. Each of our FDA consultant has their own product specialty expertise in regulatory and quality systems.

We serve companies of all sizes and product classifications within your budget. Please contact us for a quote for your submission