Close-Out Meetings With FDA Investigators: What Manufacturers Need To Know Before Their Next Inspection
A Compliance 360° Q&A
When the US agency comes to inspect a manufacturer’s facility, one of the more important activities that occur is a close-out meeting. Consultant and former FDA investigations branch director Ricki Chase explains why these meetings, held daily or at the end of an audit – or both – can help make or break an inspection.
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Over the past year a number of medical device sterilization facilities that use ethylene oxide, or EtO, have shut down as state regulators have raised concerns about their potential environmental impact. On this week’s podcast, executive editor Shawn M. Schmitt chats with senior reporter Danny Al-Faruque about what’s happened to date, as well as where this EtO issue is headed in the future.
Analyzing Quality Data Is Essential. Here’s What One Expert Says Your Firm Should Do To Stay In FDA’s Good Graces
Device makers should make sure they have adequate resources to analyze quality data they take in so they can prevent the recurrence of nonconforming products, processes and procedures. That’s just one nugget of advice from former FDA investigations branch director Ricki Chase, who explains why collecting and properly handling such data is critical to complying with agency expectations in this Medtech Insight Q&A interview.
US Regulatory Roundup, November 2019: EtO Woes Concern Industry; FDA Pushes Back Deadline For Blended QSR/ISO 13485 Rule; And More
Concerns expressed by stakeholders during a two-day FDA meeting on the use of ethylene oxide (EtO) to sterilize medical devices was of most interest our online readers last month. EtO was also the focus of several other highly read stories – including worries by industry about device shortages and news that device maker Teleflex expects to lose millions because an EtO facility shut down. Meanwhile, the FDA’s announcement that it would push back its deadline for delivering a draft version of a new rule that will harmonize its Quality System Regulation with ISO 13485 also garnered significant interest. Here are November’s 10 most popular US regulation and policy stories from Medtech Insight.