Preparing a US FDA Medical Device 510(k) Submission and Deciding When to Submit a 510(k) for a Change to an Existing Device
Objectives of the Presentation
Medical device technology is constantly evolving, and the approval for another company to produce the same approved Medical Device product requires FDA´s review and consent. The new FDA 510K recommendations are intended to provide guiding principles to help manufacturers determine when an intended product or minor change to a legally marketed medical device subject to premarket notification in compliance with the 510K requirements is significant enough to warrant FDA review and approval, including major changes or modifications to the intended use that could significantly impact safety and effectiveness (patient risk).
- Whenever a manufacturer changes its device, it must take certain actions to comply with the QS regulation, 21 CFR Part 820, unless a regulatory exemption exists. The QS regulation which includes your CAPA procedure requires that design changes and production and process changes be documented and proven to be just as good and not generating any patient risk and notifying the FDA for this change from the original approval prior to implementation.
- In evaluating whether a change requires a new 510(k), manufacturers have to consider whether there are any unintended consequences, needed clinical trials or effects of the device change. For example, changes in sterilization may unintentionally affect device materials, or changes to materials may unintentionally affect the performance of the device.
- FDA Briefing Documents - The purpose of the pre-facility meeting is to provide detail and seek FDA´s input regarding your company’s proposed new manufacturing facility or the new manufacturing process, single use disposable manufacturing technology and to confirm that the proposed approach will provide adequate comparability data between the product that was proven to be functional based on the clinical results and now as is going to be used for commercial manufacturing in the new facility since the product produced in the pilot facility and used for the initial Phase II/III clinical trials.
Why Should you Attend
Generate the technical comprehension and technical writing capabilities to eliminate corporate interpretations and translations of technical terms relative to the specifics of your specific process needed for a 510K submission. We always want to make the submission in a way that does not require any interpretation and delay. In order to get a quick approval the FDA should read the documents & come to the same conclusion that we did to generate the production process for this product ensuring we are not generating any patient risk.