The Wood Burditt Group provides counsel to device manufacturers, marketers, and distributors. We assist in all matters related to FDA’s Center for Devices and Radiological Health.
We advise clients on medical device research and marketing. This includes providing services related to Premarket Approval Applications (PMAs), Premarket Notification Submissions (510(k)s), and Investigational Device Exemptions (IDEs). Accordingly, we provide counsel on the labeling, advertising and promotion of devices. And for devices that have been approved or cleared by FDA, we assist with establishment registration and listing requirements.
We assist with all manufacturing aspects of medical devices, including Quality System Regulations (QSRs) and current good manufacturing practices (cGMPs). We provide guidance and auditing capabilities related to QSRs/cGMPs and performance standards for radiation-emitting electronic products and medical devices. We also assist clients with FDA inspections, FDA 483s and Warning Letters.
Additionally, we assist with the legal issues related to the collection, analysis, and action stemming from information about injuries and other experiences in the use of medical devices and radiation-emitting electronic products. We are able to advise on matters related to recalls, injunctions, and seizures.