The Food and Drug Administration has published a final rule to reclassify Medical Device Data Systems (MDDS) from Class III devices requiring premarket approval to Class I devices regulated under much less stringent general controls.
The FDA’s new ruling states, “An MDDS is a device that is intended to transfer, store, convert from one format to another according to preset specification, or display medical device data.” This impacts software and even intermediate devices used to retrieve data from medical equipment, other medical systems and medical devices. While this will make life a little easier for devices formerly classified as class III, other systems which were not considered medical devices will now have to adhere to more compliance controls as any manufacturer of an MDDS must establish compliant quality systems for the design, manufacturing and validation of their MDDSs as well as adverse event reporting procedures by April 17th, 2012. While there was ambiguity about this in the past and companies could argue that their system was not a medical device, this new ruling makes it clear that this is no longer the case. Every MDDS must be maintained in a compliant quality system.
Full Spectrum Software is currently assisting companies impacted by this new ruling by providing a “retrospective compliance” service. By means of this process, necessary documentation and design controls are put in place to ensure traceability of requirements, production, verification and validation and the product is adopted into Full Spectrum’s ISO 13485 certified quality management system.
The process begins with an accounting of software components, system architecture, requirements and product history. The information is distilled into formal requirements, design documentation, test preparation and documentation to support empirical validation. The system is entered into design control and taken through an internal release cycle which includes manual and automated testing, defect reporting and defect repair. We then collaborate with our clients to efficiently and professionally deliver completed documentation for the product which is often accompanied by a new release of the product.
Contact us today to find out how.