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FDA Opens Performance Pathway To Four Dental Device Types

 
• By Elizabeth Orr

Guidance documents issued 30 September explain how makers of air powered dental handpieces and air motors, dental cements, dental ceramics, and dental impression materials can bring their products to market by demonstrating compliance with established criteria, without a direct comparison to a predicate device.

The US Food and Drug Administration is adding four additional dental device types to the Safety and Performance Based Pathway, easing the products’ path to market.

The pathway, which was established in 2019 as an outgrowth of the Abbreviated 510(k) program, allows some types of devices...

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J&J MedTech’s Digital Head Pushes for Smarter, Standardized ORs With AI and Open Tech

 
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J&J’s global head of MedTech Digital envisions AI-powered connected operating suites within a decade. In an interview with Medtech Insight, Shan Jegatheeswaran discusses how J&J, together with partners like NVIDIA and AWS, is laying the foundation for open platforms for standardized surgeries.

Roberts’ Departure At NICE Sparks Hunt For New CEO

 
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Healthtechs are reflecting on the resignation of Sam Roberts as chief executive of NICE and how medtech assessment program changes underway at the England and Wales HTA body might be impacted.

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

 
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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.

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

 
• By Natasha Barrow

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.

More from Policy & Regulation

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

 
• By Elizabeth Orr

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.

Bipartisan Senate Bill Would Give Patients ‘True Price Tag’ Prior To Care

 
• By Brian Bossetta

Pending legislation seeks to address what the sponsors argue is a lack of transparency in medical billing. If enacted, the bill would provide patients with the costs of procedures and medications before receiving them. A data collection expert discusses what the bill could mean for patients.

How Notified Bodies Would Like Future EU Medtech Governance To Pan Out

 
• By Amanda Maxwell

Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.