Description
This continually updated course covers current FDA
regulatory compliance issues with respect to developing,
manufacturing, and marketing medical devices. It includes an
overview of the FD&C Act, case law, and pertinent FDA
regulations. Among the many topics to be discussed will be:
FDA’s regulatory policies, how they develop and where they
are documented; potential FDA enforcement for
noncompliance including warning letters, injunctions, seizures,
civil penalties, and criminal prosecutions; device classification
and reclassification; premarket submissions requirements for
510(k)s, IDEs, PMAs, and PMA Supplements; device
promotion and advertising; post market requirements
including establishment registration, device listing, and
adverse event reporting; inspections; recalls; and the QSR,
including design controls and process validation. The course
will focus on the application of the law, regulations, and
policies to medical devices.
