Kyper & Associates is an association of independent consultants providing regulatory and technical services to the medical device industry and the legal profession. The firm’s services include the interpretation, applicability and enforcement of FDA laws, regulations, guidances and policies; development of regulatory and testing strategies; preparation or critique of 510(k), IDE, and PMA submissions, reclassification petitions, required reports, responses to FDA deficiency and warning letters, and other submissions; development or assessment of labeling, advertisements, and other promotional materials and programs; preparation for and representation at FDA meetings; GMP/GCP/MDR compliance audits; due diligence investigations; litigation assistance; and expert testimony.
Charles H. Kyper, RAC, the firm’s founder and principal consultant, started his 28-year FDA career in 1966 as a FDA field office investigator (drug specialist) and later served as a compliance officer in the then FDA Bureau of Drugs. In 1977 he initiated and directed the Industry Services Staff in the CDRH Office of Small Manufacturers Assistance. He had significant input into the development of regulations and programs implementing the Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990. He was the Director of the Premarket Approval Staff (1981-1990) and Assistant Director for Reclassification and Compliance (1990-1994) in the CDRH Office of Device Evaluation (ODE). In the latter capacity he was the primary ODE resource for regulatory guidance and was the ODE liaison with the CDRH Office of Compliance for regulatory matters involving device marketing submissions, labeling, advertising and promotion. From 1985 to 1994 he was also the CDRH Coordinator for its device master file, color additive, environmental assessment and patent term restoration programs.
Mr. Kyper is a member of the Regulatory Affairs Professionals Society (RAPS. He was Regulatory Affairs Certified (RAC) by RAPS in 1994.
As a consultant Mr. Kyper has provided expert reports, depositions, and expert court testimony in numerous and varied litigation matters. He represents plaintiffs and defendants based on the merits of the case.
His publications include numerous feature articles in device trade journals, the CDRH Premarket Approval Manual, and Office of Device Evaluation guidances on device labeling, device master files, and other device-related matters. Mr. Kyper served from 1997 to 2001 on the Board of Editors of Regulatory Affairs Focus published monthly by RAPS. He has made more than 100 presentations at conferences, workshops and FDA panel meetings on a wide range of device regulatory topics.
