Change control plans for AI/ML, remanufacturing of devices and medical device shortages are among the guidances the FDA Center for Devices and Radiological Health (CDRH) is prioritizing in 2024. The agency is seeking stakeholder feedback on the list of guidance documents it intends to publish in the coming year.
On August 11, the FDA released a Final Guidance on Off-the-Shelf Software Use in Medical Devices, which supersedes Off-The-Shelf Software Use in Medical Devices issued September 27, 2019.
The recently announced “Refuse to Accept Policy” signed into law under section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the FDA more traction to encourage the medical device manufacturing industry to utilize software bills of materials that help to incorporate supply chain security. The ISA/IEC 62443 series of standards defines a secure product lifecycle process that can be adopted by medical device manufacturers to identify and manage the security risks of all external components used within the product.
Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.
The increase in global regulatory demands for medical devices has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory professionals, device developers and regulators to look at current trends in FDA and international pre-market and post-market requirements, as well as key pain points in achieving regulatory compliance throughout the product lifecycle.
Point of care 3D printing of medical devices has abundant potential. However, many regulatory uncertainties remain.
Mitigating risk of failure is one of the most important disciplines to perform for medical device manufacturers, and for the last couple of years, it has become an increasingly difficult discipline to master.
Mahofski will be responsible for identifying and pursuing acquisition opportunities that complement RQM+’s core regulatory services and provide a comprehensive range of fully integrated outsourced solutions to help get MedTech products to market faster and ensure ongoing regulatory compliance.
Taking these compliance challenges into account will allow healthcare organizations to prepare for compliance audits, but more importantly it will help institutions address issues that result in a negative patient outcome.
“The MedAccred Labeling, Printing and UDI Task Group’s role is to provide medical device companies with structure and requirements to assist in identifying and implementing industry best practices for global market compliance.”