Shawn M. Schmitt
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Latest From Shawn M. Schmitt
Compliance Corner: J&J Quality Expert Urges Makers Of Combo Products To Be 'Bilingual' In Device- And Drug-Speak
Speaking the language of both devices and drugs is an important step sometimes missed by makers of combination products. Being "bilingual" is especially important during a facility inspection by US FDA, Johnson & Johnson's Susan Neadle says.
Benefit-Risk Is Front-And-Center In Latest Revision Of International Risk Management Standard ISO 14971
The International Organization for Standardization (ISO) has strengthened benefit-risk language in the latest redo of ISO 14971, the voluntary standard that instructs device-makers on how to best put together a risk management program. Regulators – including US FDA – are increasingly considering benefit-risk when weighing product availability and regulatory compliance issues. And Jos Van Vroonhoven, convener of a joint working group that revised the standard, says a more global regulatory emphasis on risk management and a desire to clarify the document in general led ISO to revise the standard. Also: Van Vroonhoven identifies four updated clauses in the revamped standard that firms should keep a sharp eye on.
The Path Forward: Retooled Technical Doc TR 24971 Guides Device Firms On Risk Management Standard ISO 14971
When ISO TR 24971 – a Technical Report that offers device-makers guidance on international risk management standard ISO 14971 – was first published in 2013, not many people knew it existed. But now that the TR is being updated in tandem with ISO 14971, it's a must-have document that includes valuable instruction related to a host of risk-related issues. In particular, TR 24971:20XX includes informative new annexes that tackle device cybersecurity and how firms should handle risk management for products designed before ISO 14971 existed.
Here's a table cross-referencing the current 2007 version of international risk management standard ISO 14971 and its revised draft version, which will likely be published by the International Organization for Standardization (ISO) later this year.
FDA Lowers Age For Electroshock Devices From 18 To 13 In Final Order; Gives Makers Of Down-Classified ECTs 6 Months To Submit 510(k) Amendments
A Dec. 26 final administrative order from FDA says people as young as 13 who suffer from major depressive disorders can now be treated with electroconvulsive therapy (ECT) devices that have been newly down-classified by the US agency, from high-risk class III to moderate-risk class II with special controls. Manufacturers of ECT devices covered by the final order have 180 days to submit an amendment to their product's 510(k) that shows how their device meets the special controls. Meanwhile, makers of class III ECT devices that were not redesignated as class II must file a pre-market approval application with FDA within 90 days.
On this week’s podcast, senior reporter Elizabeth Orr gives a recap on the year in US legal news and how the courts impacted the medical device industry, from new Supreme Court justices Neil Gorsuch and Brett Kavanaugh to multimillion-dollar settlements in device safety cases – and much more.