FDA proposes major changes to Medical Device Quality Regulation

The rule that is proposed, Medical Devices; Quality System Regulation Amendments, incorporates ISO 13485:2016

which is the internationally recognized consensus standard for manufacturers of medical devices. The less complicated regulation process could result in FDA savings in the $439-$533 million amount over the following 10 years, as per the executive summary of the proposal.

 

US FDA

According to the FDA its regulations, the expectations of the QMS have changed from the time the FDA's current regulation was adopted more than 20 years back.

The FDA has stated in its announcement that it would like to ensure that quality management systems are in line with requirements for devices to the requirements that are used by other regulatory authorities around the world.

The FDA explained in the proposal's executive statement: "These additions will ensure that the incorporation of ISO 13485 by reference of ISO 13485 does not create contradictions to other FDA regulations. ... When approved, will bring convergence of the QS regulation with QMS specifications from ISO 13485, while continuing to provide the same degree of assurance for safety and efficiency under the FD&C Act and its implementing regulations."

The proposed changes will also clarify the requirements of QMS for devices for products that combine.