Gain market access in the United States with FDA approval

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Food and Drug Administration (FDA) and 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)

MDSAP Medical Device Single Audit ProgramThe 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 Auditing Organizations (AO), such as BSI, which are authorized by the participating RA to audit under MDSAP requirements. MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.

A BSI MDSAP audit can also be combined with assessment for CE and ISO 13485.

MDSAP - Find out more >

What is BSI's role in global market access?

BSI employs over 700 people within the medical device team 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 clinical, sterilization processes, and animal tissue utilization to combination medical device products.

Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies which include:

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