Evan Phelps

Evan Phelps is a principal at OFW Law. He advises companies on compliance with Food and Drug Administration (FDA) law and regulations, with focus on matters related to medical devices and biologics as well as those affecting Clinical Investigators. This includes Assistance in the preparation of Premarket Approval Applications (PMAs), Premarket Notifications (510(k)s), and Investigational Device Exemption (IDE) Applications; Advice, training, and assistance with matters concerning the Quality System Regulation (QSR) and the Medical Device Reporting (MDR) Regulation; Assistance with responding to and resolving issues relating to: FDA establishment inspections, Forms FDA-483 (Inspectional Observations), Warning Letters, Recalls, Injunctions, Import/Export of FDA-regulated products, and Product labeling. Evan also assists in Clinical Investigators and IRBs with compliance, enforcement, and training issues. He advises companies on the impact of FDA law on business transactions and agreements; development of specially tailored plans to bring medical devices to market based upon client needs and goals; and assists in filing or responding to trade complaints.