FDA to Transition to ISO 13485

ISO 13485

This week, the FDA’s Center for Devices and Radiological Health (CDRH) announced its plans to create new regulations that would blend together two leading approaches to auditing medical device quality management systems, 21 CFR Part 820 and ISO 13485.

According to the organization, there is approximately a 95% overlap between the two guidelines; the remaining 5% still needs to be hashed out. Included in this small fraction are medical device reports, unique device identification (UDI), and the Medical Device Single Audit Program (MDSAP). As explained by the Regulatory Affairs Professionals Society (RAPS), the “FDA plans to leverage MDSAP for its nationwide adoption of the globally agreed upon standard on device oversight as the audits are conducted against 13485 under this program.”

Upon its launch in 2014, only 4 manufacturing sites were participating in MDSAP. Today, over 3,600 sites worldwide have joined and over 50% of those sites are located in America. Sites are becoming increasingly interested in saving time and cutting costs through the viral program.

Ultimately, this transition signifies a major step in the modernization and harmonization of global medical device regulations as well as aims to add more consistency to the CDRH’s auditing process.

__

RegDesk is an A.I.-powered regulatory intelligence software that offers 24/7 access to the latest regulatory information for over 50 markets worldwide. Our platform eliminates the need for medical device companies to spend months gathering intelligence and preparing their registration applications. Through RegDesk’s centralized platform, clients can get access to product-specific registration requirements, expert answers to their most critical regulatory questions, and real-time alerts about global regulatory changes. To experience the power of RegDesk, contact us at desk@regdesk.co or visit www.regdesk.co.