United States market access

Food and Drug Administration (FDA) and Center for Devices and Radiological Health (CDRH)

USA market accessThe 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.

FDA Voluntary ISO 13485 Report Submission Program

BSI is one of the certification bodies that FDA will accept ISO 13485 QMS reports under their voluntary program.

Under this program manufacturers can voluntarily submit their ISO 13485 QMS reports and certificates and if everything is acceptable to FDA they remove themselves from the FDA inspection roster for up to 12 months.

Full details and eligibility criteria.

Medical Device Single Audit Program

BSI is preparing for the MDSAP, expected to pilot in 2014 where manufacturers can voluntarily select to have an audit conducted by a designated Auditing Organization (AO) where the audit report will be potentially accepted by four regulators including US FDA, Health Canada, ANVISA and TGA. Program details to be announced soon.

Learn more about the Medical Device Single Audit Program (MDSAP).

How can BSI help me gain access to global markets?

BSI employs over 100 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.

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