FDA’s Device Center Looks To Risk Management As It Pens Quality-Related Inspectional Guidance

Ensuring that a good risk management program is in place is more important than ever now that CDRH plans to rely on the concept to inform new inspectional guidelines for FDA investigators. Using risk management information, the center hopes to be better poised to identify device-specific points that should be looked at closely during an agency audit to ensure quality. Critical-to-quality points are already being identified for implantable devices that contain batteries. Beyond that, senior-level CDRH officials have hinted that CTQs will eventually be pinpointed for more high-risk products. In the meantime, industry experts say it’s important for manufacturers to reexamine aging risk analyses and systems to make sure they’re still effective.