Vice President, Regulatory Affairs, MDMA
Heather Rosecrans brings more than 30 years of public health and medical device experience to MDMA. Rosecrans continues her commitment to public health at MDMA where she provides strategic consulting services and works with MDMA members to bring innovative devices to patients.
Prior to joining MDMA, Rosecrans served as Director of the 510(k) Pre-Market Notification Staff at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). In this role, Rosecrans was responsible for implementing administrative and regulatory policy for the 510(k) Program, the 513(g) Program, Classification and Reclassification, de novo petitions and other premarket regulatory requirements.
Rosecrans started her FDA career as a biologist in the agency’s Bureau of Medical Devices – prior to the formation of CDRH. In 1980, Rosecrans joined the newly organized CDRH Premarket Application (PMA) Staff. For the next seven years, she coordinated the administrative, scientific and regulatory review of PMAs, product development protocols and associated submissions.
In 1987, Rosecrans joined the 510(k) Section of CDRH’s Program Operations Staff (POS). In this role, Rosecrans served as a Consumer Safety Officer and was a key contact for CDRH and FDA on 510(k) matters. Rosecrans held this position until 1992, at which time she became Director of the 510(k) Staff. Rosecrans’ accomplishments include drafting guidance documents and regulations regarding the 510(k) program, training staff, and assisting in the implementation of the Medical Device User Fee Modernization Act (MDUFMA) and Food and Drug Administration Modernization Act (FDAMA).
Rosecrans’ extensive experience at CDRH, and specifically the 510(k) office, enabled her to become one of the nation’s leading experts on the program. Rosecrans’ tenure also allowed her to play a pivotal role in the program’s development and reform. Since the program's inception in 1976, more than 120,000 products have been cleared via the 510(k) program.
Rosecrans has represented and spoken on behalf of CDRH in multiple forums, including national conferences, FDA advisory committee meetings, and international symposiums. Her published work includes numerous guidance and regulatory documents. She has also worked collaboratively with CMS and other regulatory agencies.
Rosecrans holds a Bachelor of Science in Biology from Pfeiffer College in Misenhelmer, NC.