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US FDA Maturity Model Pilot Program Gets October Meeting Date

 
• By David Filmore

The agency wants to hear public feedback on its plan to employ a standardized model to measure a company's manufacturing "maturity" via third-party assessments to support regulatory and compliance decisions.

US FDA is convening a workshop at its Maryland headquarters on Oct. 10 to discuss its plans for a pilot project that would use third-party assessors to measure the maturity of a company's manufacturing systems to help shape the agency's regulatory, compliance, and enforcement decisions.

The agency has been working closely with the Medical Device Innovation Consortium to adapt the well-established "Capability Maturity Model Integration"...

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Digital Health Roundup: BCIs Surge Ahead, Oura Eyes BP Clearance, AI Faces New Scrutiny

 
• By Marion Webb, Brian Bossetta, Elizabeth Orr, and Shubham Singh

Brain-computer interfaces advance toward trials and commercialization, Oura pushes for FDA-cleared blood pressure monitoring, and regulators weigh AI’s expanding role in mental health and diagnostics amid rising safety concerns.

Lack Of Taxpayer Value Leads UK MHRA To Shutter RegulatoryConnect Transparency Program

 
• By Eliza Slawther

The UK Medicines and Healthcare products Regulatory Agency said its RegulatoryConnect program “no longer offers value for money for UK taxpayers” and will be closed just 19 months after its April 2024 launch.

FDA’s New Menstrual Products Guidance Focuses On Product Risks

 
• By Elizabeth Orr

The US FDA is updating its menstrual products guidance for the first time since 2005, adding new recommendations for menstrual cups as well as additional testing guidelines. The document also reflects a new awareness of the potential risks of contaminants within menstrual products.

With QMSR Nigh, FDA Drops Guidance To Help Industry Prep For New Regs

 
• By Brian Bossetta

The US FDA has issued a draft guidance document to help device manufacturers navigate the new Quality Management System Regulation (QMSR) concerning premarket approval applications and humanitarian device exemptions applications. The new regs take effect in February.

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Hundreds Of Adverse Events, Multiple Deaths, Associated With Abbott Correction Of Libre 3 Sensors

 
• By Brian Bossetta

Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.

LDTs Aimed At Catching Cancers Early Hold Promise In Reducing Late-Stage Diagnoses, Study Shows

 
• By Brian Bossetta

A recent study demonstrates that certain types of blood-based tests that screen for multiple cancers at once have the potential to flip the script on cancer diagnoses, including some of the deadliest types.

How The EU’s Digital Omnibus Package Could Provide Breathing Space For Medtech

 
• By Amanda Maxwell

The European Commission seems to have heeded many of the medtech industry’s points regarding challenges with the implementation of the AI Act within the Digital Omnibus. But the usual EU hurdles must be crossed before the sector will know if these proposals will make it into law.