Introduction to Biomedical Software Regulation

Thomas E. Colonna
Thomas E. Colonna
60 Minutes
Product Id:
6 months

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The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).

Computer software was in a state of infancy during the 1970's and the role computer software would eventually play in the provision of healthcare was not foreseen. FDA did not have to create a software regulatory policy until the late 1980's when companies began incorporating primitive software programs in medical devices.

Software can be a device by itself (i.e., stand-alone) or it can be incorporated into another device as a component, part or accessory.

Under the current policy, FDA distinguishes between stand-alone software and software that is a component, part or accessory to a device.

Why should you Attend: To gain a fundamental understanding of biomedical software regulation.

Areas Covered in the Session:

  • Definition of biomedical software
  • FDA's biomedical software regulatory scheme
  • Software validation
  • Level of concern

Who Will Benefit:
  • Regulatory Professionals working in the Medical Device and Biomedical Software Fields

Speaker Profile
Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. In addition, Dr. Colonna holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia.

Dr. Colonna provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, and pharmacogenomics), medical device software (including bioinformatics), and biotechnology-based products.

Dr. Colonna's consulting clients range from Fortune 500 companies to small start-up companies located throughout the US, as well as, Canada, India, and Russia. Widely published in numerous fields, Dr. Colonna brings a unique multidisciplinary approach to problem solving.

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