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Device History Record ‘Oversights’ A Clear Path To Quality Troubles, FDA Says

This article was originally published in The Silver Sheet

Executive Summary

Manufacturers are overlooking various key elements that should be included in device history records, including up-to-date labels, dates of product manufacture and missing signatures on documents, FDA says. Because DHRs touch virtually every part of a firm’s quality system, a flawed DHR can prompt agency investigators to dig deeper during inspections. Further, DHRs with absent signatures, test records or traceability records might cause investigators to doubt the validity of a manufacturer’s quality system. Experts also urge companies to make sure that device history records link to device master records, and they remind firms that DHRs are also tethered to production and process control requirements. Some manufacturers are in the beginning stages of implementing electronic device history records in an effort to curb mistakes and unnecessary costs.

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From our digital archives: Device changes and design history files are integral aspects of design control that work hand-in-hand and should not be overlooked by manufacturers, industry experts said. Firms should keep copious records of design changes that can later be reviewed in a design history file (DHF); otherwise they could encounter what one expert dubbed “change creep.” This happens when a manufacturer makes numerous changes to a product, “and then all of a sudden we have a design that doesn’t even look like the original device,” John Gagliardi of MidWest Process Innovation said in December 2012. Further, firms should ensure that human factors are taken into consideration when design inputs are gathered.

Anatomy Of A Unique Device Identifier: It’s Flexible

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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?

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