Medical Device Single Audit Program: FDA Wants You
The Medical Device Single Audit Program (MDSAP) is transitioning to full implementation by January 1, 2017. In anticipation, FDA has set up 10 medical device education modules to help companies learn more about MDSAP. Available in the CDRH Learn section of the FDA website, the modules cover the following areas surrounding MDSAP:
- Introduction to MDSAP
- MDSAP management
- Device marketing authorization and facility registration
- Measurement, analysis and improvement
- Adverse events and advisory notices reporting
- Design and development
- Production and service controls
- Purchasing
MDSAP was developed by FDA with regulatory agencies from Australia, Brazil, Canada and Japan. The program enables device companies to contract with an MDSAP-authorized auditing organization to conduct a single audit against relevant device regulatory requirements.
Related Articles
-
The MDDT program was developed in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse (NIDA), National Institute of Dental Craniofacial Research (NIDCR) and National Cancer Institute (NCI) as a way for the FDA to qualify…
-
The Food and Drug Omnibus Reform Act (FDORA) authorized FDA to conduct remote device facility inspections. While it will take time for the FDA to take the necessary steps to start performing remote inspections, industry can look to remote regulatory…
-
Following Karl Storz’s recall of urological endoscopes, the agency wants to make sure that healthcare providers have seen the company’s urgent labeling update involving sterilization methods.
-
The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in the UK market.
