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Quality Control

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US FDA Device Center Pushes 'Total Product Life Cycle' Concept; 'Reorganization' Coming, Says Compliance Chief

The Center for Devices and Radiological Health is shaking up how its pre- and post-market specialists interact under a new "Total Product Life Cycle" scheme.

Life Cycle Management Quality Control Compliance
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Snapshot: Device Recalls Tick Up Only 1% In 2016 Despite Midyear Surge

A count of fiscal year 2016 recalls provided by the agency shows that there were 43 high-risk class I (4%), 1,090 class II (92%) and 50 class III (4%) recalls last year, up a mere percentage point from the prior year. Device-makers had been on pace for a more modest number of corrections and removals for 2016, but a sudden mid-calendar-year spike in recalls caused the total to jump significantly.

Recalls Compliance

Medtronic StratMR Device Gets Class I Recall

Following a voluntary recall from Medtronic of its StratMR adjustable valves and shunts, US FDA has issued the highest level of recall for the devices, stating they could severely injure patients or cause death.

Recalls Safety

US FDA Warning Letter Scrutinizes Abbott Over Cybersecurity, Battery Lapses

FDA investigators are concerned Abbott's St. Jude Medical subsidiary failed to adequately address concerns over cybersecurity vulnerabilities and premature battery drain on their cardiac devices manufactured at its Sylmar, Calif., facility.

Regulation Compliance

Artificial Intelligence Center To Offer Quality, Regulatory Solutions

In this Medtech Insight podcast, Xavier University's Marla Philips explains why the school is teaming up with IBM Watson Health to launch a Center for Artificial Intelligence. "Our mission is to provide artificial intelligence solutions. We will have free and open access for anyone to use so they can implement those solutions across the pharma and device industries, and FDA itself," she says. Also: will AI steal human jobs?

Quality Quality Control

Mylan’s EpiPen Recall: Another Hit On The Auto-Injector

What began as an overseas recall of one lot made by a Pfizer subsidiary is expanding, threatening to besmirch Mylan’s once golden supply-chain quality record. The recall follows pricing controversy around the EpiPen product got the CEO hauled before Congress.

Safety Combination Products

House Subcommittee Grills Shuren On Facility Inspection Shortfalls

Members of the House Energy & Commerce Health Subcommittee probed FDA device-center chief Jeff Shuren about the agency's nascent efforts to improve facility inspections during a recent hearing on user-fee reauthorization. Lawmakers say they are hearing complaints from constituents about a lack of consistency and transparency in FDA inspection practices. Bills have now been introduced in both the House and Senate to address the issue, while FDA embarks on its "program alignment" upgrade to its inspections program.

Legislation Quality Control

US FDA's 'Program Alignment' Inspection Scheme Coming Mid-May; Details Still Murky

The agency's new inspectional approach – which will be structured along commodity-specific product lines – will be ready for primetime on May 15, the device center's compliance chief says.

Quality Control Compliance

Warning Letter Nosedive: US FDA Writes Fewest Quality-Related Missives Since 2002; Agency Isn't Sure Why

Only 57 quality-related warning letters were issued to device manufacturers in 2016, a 14-year-low that has left US FDA scratching its head as to why so few were sent to firms. "Our analyst team talked to both managers and staff alike within the device center, within ORA, and we could not identify a single factor or event to attribute the drop to," FDA compliance office official Sean Boyd said in an interview. Also: US inspections are down 2%, while foreign audits are up 16%; the top three quality system violations are revealed by FDA; an update on the number of close-out letters sent to firms; and more.

Device Warning Letters Quality Control

Compliance 360° Part 8: Patient Influence On US FDA’s Enforcement Strategy

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this eighth and final installment, former US FDA investigations branch director Ricki Chase explains how the role of the patient influences FDA's enforcement strategy and discusses the agency's recent industry guidance on benefit-risk factors.

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