Medical Devices
The medical device sector wields a profound impact on its audience, often changing lives. Navigating the stringent regulations governing this field demands a lawyer well-versed in FDA and FTC regulations.
At Talati, we counsel our clients from the initial stages of product conception and approval through to the launch and subsequent marketing of the product considering the intricate intersection of business needs and compliance requirements.
Our comprehensive services to the medical device industry encompass:
- Counseling on device classification, listing and establishment registration with the FDA.
- Preparing and filing 510(k) premarket notification to FDA.
- Counseling on safety testing and clinical studies.
- Reviewing substantiation and advising on product claims.
- Helping with product recalls and FDA inspections.
- Responding to Warning Letters and FDA enforcement actions.
- Reviewing website and social media pages for compliance.
- Counseling on Import issues including detention and refusals, Import Alert removal and product reconditioning.