Like the pharmaceutical industry, the medical device industry has a literally life changing impact upon the audiences it serves. Bringing a product to market in this intensely scrutinized field requires a team that is well versed in the regulations like FDA pre-marketing reviews and FTC advertising standards, plus deeply knowledgeable about patent and trademark law, and litigation.
Amin Talati Wasserman’s Medical Device group guides clients through the evolution of their products. We first address the initial question: Is the product a medical device that will be regulated by the FDA or a consumer product that will be regulated by the CPSC? Often times a word or two in a product claim, or small changes to a product design, can determine how it is regulated. If the product is a medical device, the next questions are: how is it classified (Class I, II or III) and what FDA review is needed to market the product? It may require a premarket approval (PMA), a premarket notification (510(k)), or it may be exempt. We work with our clients to determine the best route to market, and then guide them through the process.
Once the device has been cleared for marketing, our team is well versed in medical device regulatory requirements. We help our clients with facility registration and product listing, import questions, quality system regulations (GMPs), adverse event reporting (MDRs), FDA inspections, product recalls, and more. In addition, particularly with over-the-counter devices, we assist clients in developing labeling and advertising campaigns that comply with applicable laws and meet marketing objectives.
In addition to acting as strategic regulatory counselors from product inception, we remain with our clients through subsequent stages, including when they are challenged by competitors or governmental agencies, defending against consumer class action suits, responding to FDA Warning Letters, and defending patent infringement claims and commercial disputes, to name a few.
Our team helps clients comply with the myriad of FDA statutes, regulations and policies as they relate to drugs and devices. More than just legal advisers, we support companies with a broad range of financial, operational, marketing, and investigatory/enforcement issues. We are particularly proud of our interdisciplinary team: many of our lawyers have worked for regulatory agencies and in private industry, and have backgrounds in biostatistics, medicine, biomedical engineering, material science, and genetics, among other disciplines like business. We understand medical technology and thus can make better arguments on our clients’ behalf.