Design Control Snapshot: Advice About Design Change, Files, Inputs And More
This article was originally published in The Gray Sheet
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.
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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.
Jeff Shuren, director of the US FDA’s device center, says the agency is drafting a guidance document that will give industry recommendations on how it should handle products granted emergency use authorization during the COVID-19 public health emergency, once it’s over. The guidance will also address already-approved devices that were modified by their makers under enforcement discretion.
Yes, Gottlieb’s in there twice; things get complicated when an agency starts to lose credibility.