Gifts For Industry: From Waived Inspections To Pre-Market Leeway, US FDA Woos Firms For Maturity Pilot
FDA wants to give away a basket of goodies to manufacturers that voluntarily play in an upcoming pilot program that will help the agency determine the manufacturing maturity of device-makers by using the CMMI maturity model appraisal process. Incentives to join the pilot include FDA delaying regularly scheduled facility audits, waiving preapproval inspections, allowing more leeway for 30-day notices and pre-market submissions, and easing up on the issuance of FDA warning letters. A major goal of the initiative is for the agency to have greater confidence in firms that demonstrate high-quality, gold-star quality systems so it can focus its limited resources on less mature, troublesome firms.
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FDA’s Case For Quality Head Explains The Agency’s 2020 Maturity Model Pilot For Naughty Manufacturers
Cisco Vicenty tells how the US agency will structure its pilot program for device-makers with less-than-stellar compliance histories that want to use the CMMI maturity model framework to improve the quality and maturity of their manufacturing organizations – and clean up their compliance problems along the way. The FDA – which is partnering with the Medical Device Innovation Consortium (MDIC) and Pittsburgh’s CMMI Institute on the voluntary pilot – will offer the opportunity to 10 firms “that have had a negative inspection outcome, a warning letter, or possibly other regulatory action,” Vicenty explains to Medtech Insight. The pilot launches next year.
Catching Fire: FDA's Manufacturing Maturity Program For Devices Spreading Internationally – And To Drug Facilities
The US agency's Case for Quality Voluntary Improvement Program – used to measure a device-maker's manufacturing maturity and quality – has surprisingly been used to assess some pharmaceutical facilities. Meanwhile, regulators from other countries have been reaching out informally to the FDA to learn more about CFQ VIP.
Make America Manufacture Again? FDA Incentivizing 'Smart Manufacturing Solutions' To Shift Device-Making To US
The FDA wants to "Bring MedTech Manufacturing Home" – and it's well on its way to fulfilling that goal with its burgeoning Case for Quality Voluntary Improvement Program for measuring manufacturing maturity and quality. But the agency – which has already received $6m from Congress for its America-centric initiative – is working on other programs that it hopes will spur medical device innovation and production in the US.