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FDA's Maisel Updates Industry On Maturity Model Pilot, Facility Inspections, MDSAP

 
• By Elizabeth Orr

US FDA device center official William Maisel offered an update on the agency’s ongoing efforts at an industry conference last week, touting recent successes in Medical Device Single Audit Program (MDSAP) expansion and its Voluntary Medical Device Manufacturing and Product Quality Pilot Program.

Update word on card index paper - Image

An ongoing US FDA pilot program that aims to elevate product, manufacturing and process quality at device firms appears to be chalking up some early success, with 86% of participants saying the maturity model appraisals had a positive impact on the products they make.

The pilot, which launched in January 2018 and closes on Dec. 31, tallied up 32 appraisals of 18 device-makers this year, device center acting compliance office chief William Maisel said...

Under the umbrella of the joint FDA/Medical Device Innovation Consortium (MDIC) Case for Quality, the pilot uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method...

More from Regulation

More from Policy & Regulation

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By Elizabeth Orr

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.