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.

Businesswoman receiving or presenting gifts

From putting off regularly scheduled facility audits and waiving preapproval inspections, to allowing more leeway for 30-day notices and pre-market submissions, US FDA wants to hand a huge gift basket to medical device-makers that voluntarily play in an upcoming pilot program.

The pilot, which aims to determine the manufacturing maturity of firms, will be stood up in early 2018. Manufacturers that take part would use a specified maturity model and work...

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