Zulassung von Medizinprodukten in den Vereinigten Staaten mit FDA Zulassung
Food and Drug Administration (FDA) und Center for Devices and Radiological Health (CDRH)
The United States (US) Food and Drug Administration (FDA) role is to protect public health by allowing only safe and effective products to enter the market, and by monitoring products for continued safety after they are in use.
The FDA Center for Devices and Radiological Health (CDRH) is responsible for regulating companies that manufacture, repackage, re-label and/or import medical devices sold in the US.
The United States and the Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single audit to meet the QMS/GMP requirements of multiple Regulatory Authorities (RAs).
The US FDA will accept the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted "For Cause" or "Compliance Follow-up" by FDA will not be affected by this program. Moreover, the MDSAP does not apply to any necessary pre-approval or post approval inspections for Premarket Approval (PMA) applications or to decisions under section 513(f)(5) of the Act (21 U.S.C. 360c(f)(5)) concerning the classification of a device.
MDSAP audits are conducted by recognized Auditing Organizations (AOs); BSI is a recognized AO and participated in the Program's pilot phase.
Find out more about the Program, who is involved and BSI's role now.
What is BSI's role in global market access?
BSI employs over 130 medical device experts with experience in all aspects of the product lifecycle including research and development, manufacturing, and quality assurance. We offer specialized in-house expertise in areas ranging from sterilization processes, and animal tissue utilization to combination medical device products.