![]() ![]() In 1976, Congress amended the Federal Food, Drug and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use. This article concludes by identifying the arguments that have been used by counsel to successfully admit 510(k) evidence. This article examines recent trends in admissibility of 510(k) evidence, including those courts that have continued to admit 510(k) evidence to speak to regulatory compliance. This effort to exclude 510(k) evidence has gained traction in courts across the country, potentially resulting in juror confusion regarding device manufacturers’ compliance with the governing regulatory framework. In recent years, plaintiffs in medical device litigation have attempted to carve out an exception to this rule, specifically in the context of devices that are marketed pursuant to a regulatory process known as 510(k) clearance. Regulatory and compliance matters, including fraud and abuse issues, as well as assisting entities facing government investigations by state and federal agencies.ĪS a general rule, a product’s compliance with applicable regulations is properly considered as evidence in determining whether that product is defective. Caycee also has experience advising health care entities on Her practice includes general products liability, mass tort, premises liability, and medical malpractice cases. Caycee concentrates on the national and local defense of complex litigation for pharmaceutical, medical device, and cosmetic manufacturers in federal and state courts. Hampton is a litigation associate with the law firm of Carlton Fields. Survey of International Litigation ProceduresĬaycee D.Inside/Outside Counsel Relationship Survey.Diversity, Equity, Inclusion, Belonging Resources.Committee, Program, and Task Force Chairs.Commitment-Diversity, Equity, Inclusion, Belonging.Tab will move on to the next part of the site rather than go through menu items. Enter and space open menus and escape closes them as well. Up and Down arrows will open main level menus and toggle through sub tier links. Left and right arrows move across top level links and expand / close menus in sub levels. Therefore, it is your responsibility to ensure that the patient label is consistent with the final professional label.The site navigation utilizes arrow, enter, escape, and space bar key commands. ![]() Device labeling evolves throughout the review process. It should not introduce new claims that are not in the professional label. The lay translation should also provide a balanced presentation of adverse events and the risks and benefits of the device. When translating the professional label into lay language, take care to ensure that it does not alter the intent of the indications, contraindications, warnings and precautions, or other parts of the professional labeling. The writing style we have adopted in this guidance is targeted to manufacturers, since they will be developing the medical device patient labeling. (2) to assist Center reviewers in their review and evaluation of medical device patient labeling to help make it understandable to and usable by patients (or family members or other lay persons caring for patients). ![]() (1) to assist manufacturers in their development, and Center for Devices and Radiological Health ![]()
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