We provide counsel on FDA regulation and enforcement of medical devices, including:
– Providing counsel on FDA device classification, and applicable regulatory compliance requirements
– Advising on pre- and post-distribution issues regarding the labeling, advertising, promotion, and import of medical devices
– Preparing and filing 510(k) premarket notification applications to FDA
Managing risks associated with and responding to FDA enforcement and advisory actions, including Warning Letters and untitled compliance letters
– Preparing for and managing FDA inspections, including conducting pre-inspection audits; assisting during inspections; and drafting responses to Forms FDA-483 (inspectional observations)
– Conducting product recalls and other field actions
– Assisting with medical device listing and establishment registration requirements for foreign and domestic businesses, including U.S. agent representation
– Working on medical device import and export issues, such as export of unapproved devices, import detentions, Import Alerts (automatic detention), import for export, re-importation, and gray-market or parallel market import issues
Our experience includes representing domestic and international businesses, and import and export matters regulated by FDA, CBP, USDA, and EPA.
Representative Medical Device Experience
- Provided counsel on FDA enforcement policies and regulations of Personal Protective Equipment (PPE), including face masks, surgical gowns, medical gloves, and other accessories during the pandemic
- Advised on FDA device classification of dental nightguard product and successfully obtained 510(k) premarket clearance
- Successfully removed manufacturer from Import Alert that required manufacturers to have a 510(k) clearance by demonstrating medical device was 510(k)-exempt
- Provided strategic counsel on the regulatory classification of medical devices
- Assisted importer and manufacturer with the import of Research Use Only (RUO) medical devices
- Developed regulatory rationale for positioning of general wellness device
- Counseled on proposed marketing materials in consideration of 510(k) cleared indications
- Advised manufacturers and distributors on medical device listing and establishment registration requirements
- Advised on gray market or parallel market import compliance issues for Class II medical device
Why Work With Us?
- Experienced and committed: While it helps that many of the products we advise on are ones we would use or recommend to friends and family, we are invested and care about you and the issues you are facing. We dedicate our resources to resolve your questions, and to help you reach the next peak.
- Responsive: We recognize that business happens quickly. We pride ourselves on being responsive to clients, and available when you need us, whether this means accommodating international time zones or strategizing for an unannounced FDA inspection.
- Client-focused: We focus on identifying the best legal and business solutions with your products and risk tolerance in mind.
- Partnership: We like to view our partnership as a long-term relationship, growing with you as an extension of your regulatory team.
- Specialized: Our practice is niche and our expertise is specialized. Chances are we have experience and the resources to address the regulatory questions keeping you up at night.
Medical devices clients include:
· Importers · Exporters · Manufacturers · Contract manufacturers · Distributors · Trade organizations