Betty Walker Collins has been an EAS consultant for nearly 12 years, assisting medical device clients with a variety of regulatory actions including seizures, consent decrees, depositions, regulatory letters, warning letters, civil money penalties, Section 518 recall actions and recalls. Betty’s background as a Director in FDA’s Division of Enforcement, Office of Compliance, enables her to provide targeted solutions that enhance Good Manufacturing Practices (GMPs) for device manufacturing and in-vitro diagnostic industries operations. He performs Quality System Regulation inspections and audits, develops Premarket Notifications per 510(k) and Premarket Approval (PMA) applications (PMAs). She has comprehensive knowledge of FDA regulations and enforcement policies and case precedents.
Prior to consulting, as the Director, Division of Enforcement, Office of Compliance at FDA’s Center for Devices and Radiological Health, she had final division review and evaluation of proposed legal actions to ascertain compliance with enforcement policy and the adequacy of supporting evidence of legal actions. Ensuring precedent cases, Ms. Walker Collins made recommendations on proposed regulatory actions to the Office of Compliance Director and the Center Director.
Her career at FDA began as a Consumer Safety Officer (Investigator) in the Atlanta District Office. From there her progression included Director of the New York Import District, Chief of the Recall Branch in the Office of Compliance, FDA, CDRH, Chief, In-Vitro Diagnostic Devices, Office of Compliance prior to becoming Director, Division of Enforcement. During her FDA career, Betty received over 50 Awards for outstanding service performed, including two FDA Group Recognition Awards. She also received accommodation from Vice President Al Gore in 1998.
Posted in Who’s Who at EAS.