James R. Ravitz
Arent Fox LLP
JAMES R. RAVITZ is a partner in the Food and Drug and Health Groups at Arent Fox. He counsels clients on the legal and regulatory challenges facing medical device‚ drug and biologics manufacturers‚ importers‚ distributors and marketers. His practice focuses on regulatory matters involving the Food and Drug Administration (FDA) for the medical device‚ pharmaceutical and biotechnology industries. He counsels on all aspects of medical product life-cycle issues such as product development regulatory strategies‚ managing pre-submission meetings with FDA‚ preparing and filing product submissions‚ assisting in third-party audits and drafting SOPs specific to Quality System Regulation and Good Manufacturing Practice requirements‚ overseeing FDA inspections; counseling on recalls‚ FDA export and import requirements‚ and civil and criminal compliance and enforcement. Mr. Ravitz also works with companies seeking approval/clearance of combination products‚ and has prepared and filed numerous Request for Designation submissions with FDA's Office of Combination Products. In addition‚ he also advises clients on issues related to Medicare and Medicaid reimbursement of FDA-regulated products‚ including HCPCS and product coding‚ local and national coverage decisions‚ and coverage and payment. Mr. Ravitz's practice frequently focuses on the technical and scientific aspects of regulatory issues before the Federal Trade Commission (FTC)‚ such as FDA and FTC regulation of marketing and promotion of medical and consumer products. He is the vice chair of Arent Fox's Consumer Product Safety Practice and counsels clients on all aspects of regulatory activities involving the Consumer Product Safety Commission (CPSC).