Manufacturers Struggle To Determine Unique Device Identification’s Impact
This article was originally published in The Silver Sheet
Executive Summary
Unique Device Identification (UDI) will touch many parts of a manufacturer’s quality system, including CAPA, complaint handling, design control, design history files and management control, among several other areas. “Your quality system is going to be affected in any area where you deal with a product identifier,” Philips Medical Systems’ Michael Hudon points out. Many firms have already formed UDI implementation teams as they await FDA’s final regulation on the topic.
You may also be interested in...
Document Control Hot Spots – What Manufacturers Can Do To Avoid Them
Document control violations, noted in nearly a quarter of FDA warning letters in 2013, typically occur when manufacturers don’t have procedures or fail to ensure that document changes are applied systemically, FDA says. “When we list document control as an observation on FDA-483 [inspection] forms and cite it in warning letters, usually it’s because the firms don’t have anything at all – no document control procedures – or their document control procedures are inadequate,” CDRH Lead Consumer Safety Officer Ernest Smith notes. Experts also advise firms to schedule periodic document reviews and have a centralized document control group. “Don’t assume that everyone knows about document control,” says Karen St. Onge, a QA official at NxStage Medical.
FDA Releases Proposed Rule On UDI System, Ushering in ‘Modern Post-Market Surveillance System’
A proposed FDA regulation for a Unique Device Identification System is critical to the future of post-market safety surveillance, the agency says. The UDI system aims to reduce medical errors, and provide an array of other benefits for supply chain management. Makers of high-risk class III products will have one year to place UDI codes on devices. The UDI mandate will extend to moderate-risk class II devices two years later and to some low-risk class I devices two years after that.
Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?