Patricia Kaufman, Joel Schwartz Publish Article on FDA 510(k) Revisions in Law360
The article analyzes revisions to the FDA's 510(k) process that may impact medical device manufacturers in an effort by the FDA to modernize regulations. The goal of outlining the new revisions is to raise questions about the FDA's justification for modernized performance standards and the fate of older devices in cases where devices have had historically good safety profiles.
Tricia primarily counsels medical device and pharmaceutical companies on compliance and enforcement issues, including cases involving recalls, fraud and health information privacy. She also performs transactional work for her clients, including work related to mergers and acquisitions and contract matters.
Joel has negotiated matters involving the FDA, the Federal Trade Commission and the Consumer Product Safety Commission related to medical devices, tobacco regulation, clinical testing and food and drug inspection issues. He practices in the firm's Business and Commercial Litigation Division.
Read the full article here.