Global Medtech Guidance Tracker: September 2019

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-five guidance documents have been posted on the tracker since its last update.

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[Editor's note: Check out the complete Global Medtech Guidance Tracker, with sortable and searchable listings going back to 2014.]

Forty-five guidance documents on medical devices and in vitro diagnostics issued by regulatory authorities from around the world were added...

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Inspection Readiness 101: Be Prepared To Avoid Common Pitfalls When The FDA Comes Knocking

 

A panel of regulatory pros offered stakeholders tips for avoiding FDA citations after facility inspections. The July 29 webinar, hosted by ProPharma and Hyman Phelps and McNamara, follows the agency’s May announcement that it plans to up random foreign inspections.

FDA’s Small Business Eligibility Process Gets Update Before New Fiscal Year

 
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The US FDA has updated its guidance document on small business eligibility determinations for medical device firms. Industry observers urge companies to ask for the status early to avoid any potential hold-ups.

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
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The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

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NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
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Device Sterilization Plants Get Extra 2 Years To Comply On EtO Phase-Out

 
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The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.