The FDA 510(k) submission process is complex and can be challenging for companies, especially those unfamiliar with the regulatory requirements. Over the many years we've spent helping device firms gain market clearance, we've seen companies realize they need expert help in a number of areas, including but not limited to the following:
Preparation of the Submission: Preparing the required 510(k) documentation involves a complex workstream that can be time-consuming and requires a deep understanding of regulatory requirements.
Regulatory Strategy: Developing a regulatory strategy that meets FDA requirements and maximizes the chances of clearance. (Success ultimately depends on the quality of the data and information provided by the client.)
Review of Existing Regulations: Reviewing existing regulations and determining the appropriate regulatory pathway for a particular device.
Interaction with the FDA: Providing guidance on preparing and submitting pre-submission documents and scheduling meetings, responding to requests for additional information, and managing other interactions with the FDA.
A skilled 510(k) consultant is instrumental in guiding you through the process of obtaining clearance for medical devices that require a 510(k). Our consultants make sure what's often a complex and fraught process is navigated smoothly by thoroughly understanding the device and anticipating any potential obstacles. With the help of highly qualified and experienced experts, the clearance process can be completed with a much higher likelihood of success.
Each specific 510(k) consulting engagement is tailored precisely to your needs and can include, but is not limited to:
Regulatory strategy development
Assistance in determining the most appropriate regulatory pathway and the preparation of a comprehensive regulatory strategy.
Review and analysis of the device and its predicate
Determining the device's classification and the applicable predicate device(s).
Interaction with the FDA
Facilitating communication with FDA, including responding to agency questions and requests for additional information.
Support throughout the review process
Monitoring the review status, providing guidance and support throughout the review process, and managing any necessary post-submission activities.
Post-clearance support
Providing ongoing regulatory support for post-approval changes, periodic reporting, and maintenance of device marketing clearance.
Watch our Q&A with one of our experienced regulatory consultants, where we address some of the most frequently asked questions about navigating the 510(k) premarket notification process.
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Learn how The FDA Group supported a European biomedical sensor company’s
FDA premarket notification via the 510(k) pathway by redirecting its regulatory strategy to the optimal market clearance pathway, providing expert guidance to a small in-house regulatory team, and engaging with regulators.
Contact us today to take the first step toward bringing your product to market quickly and efficiently. A flawed submission will cause delays and hold up your product launch for several months—perhaps longer.
Our 510(k) consultants will give you individualized support to maximize the likelihood that your submission is successful and delay-free. Our bench of regulatory affairs talent has extensive experience and knowledge, with some having worked directly with and within FDA. They will share their expertise with you throughout the review process, providing a level of service and professionalism that's hard to find elsewhere.
