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Year In Review: Complaint Handling, UDI, FDA Inspections, And More

This article was originally published in The Silver Sheet

Executive Summary

The top quality-related topics manufacturers faced last year included a new FDA regulation to track and trace devices, innovative supply chain initiatives and an update to the agency’s Medical Device Reporting guidance, among others. Plus honorable mentions: product recalls, human factors and FDA compliance meetings.

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Long Road To Unique Device Identification: FDA’s ‘Mr. UDI’ Offers Peek Behind Curtain

The man who coined the term “Unique Device Identification,” Jay Crowley, opens up in an interview about hurdles FDA faced in setting up the system; anxiety he felt when Congress set a deadline for the final rule to be published; and why he believes UDI would have eventually happened organically anyway, among other UDI-related topics. “Sometimes people call me Mr. UDI … I think that name might stick for a while,” jokes Crowley, who planted seeds in 2002 for FDA’s new regulation to track and trace products. Since then it has mushroomed into an emerging program that has the backing of a majority in industry.

FDA’s Quest For More MDR Exemption Requests Leaves Device Industry Jittery

A draft Medical Device Reporting guidance from FDA has concerned industry experts who say the document would require manufacturers to spend an onerous amount of time submitting requests for exemption to the agency’s MDR regulation. The draft removes a longstanding so-called “two-year rule” for reporting, calls for firms and contract manufacturers to jointly seek exemptions, and asks companies to file an exemption request after selling a 510(k). Close observers suggest the agency is proposing the modifications to make it clearer to agency investigators and companies when MDRs are in fact required. FDA also likely wants to maximize the useful post-market information it receives rather than cutting off MDR reports superficially, outside attorneys explain. But some experts argue the increased emphasis on exemptions would add more burden to companies and FDA with little benefit.

FDA Investigators Talk Quality Issues And Inspectional ‘Games’ Manufacturers Play

There are plenty of typical mistakes that FDA investigators find when inspecting device firms, from failing to adequately document complaints and ensuring proper process validation, to developing ambiguous design inputs during design control activities. Yet what really grates investigators’ nerves is when they have to ask manufacturers several times for procedures and processes that are routinely asked for during an inspection. “Let’s get beyond the things that you know are going to be needed and have them readily available,” says Phil Pontikos, an agency investigator and FDA’s national device expert. In fact, firms that attempt to conceal information or stall an investigator leave themselves open to additional scrutiny by the agency. “If you want to play games, then quite frankly, we’re going to dig deep,” Pontikos says.

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