New Regulation for the FDA Will Have an Impact on Medical Device Manufacturing

The Medical Device User Fee Amendments of 2012, or MDUFA III as it has been called, will have a big impact across the industry and inevitably will also move this field forward while affecting performance goals.

The new submissions decision time-lines will gradually decrease. They will be going from 135 days in 2013 and scaling down to 124 days by 2017.

The FDA and Obama administration signed into law new regulations for the safety and innovation act that provides more funding to the medical device manufacturing industry through the introduction of new user fees that will come into affect on October 1 and will remain effective for five years.

New standards have been passed into law that improve safety, reliability and security for the medical device industry. The new fees range from $1400 through $55,000 depending on the key area of function.

The FDA will now be required to hire an outside consulting firm to determine its pre-market review process. The FDA will also change the schedules for appeals meetings and issuing decisions, and it will also change how it reclassifies devices by making amendments to this process.

The funds for new hiring and changes in process and policy for medical device manufacturing will be generated by these new fees --- and will make it possible for the FDA to add 200 more support staff to oversee these changes.

The funding will also go to provide new pathways for innovation, a de novo pathway for risk-based device classifications while expanding the post-market surveillance, while providing reductions in timelines and by amending the clinical trial approval process for medical device manufacturing.

A Unique Device Identifier will now be required for the labeling and packaging process that will dramatically increase the effectiveness of tracking devices that pour into the markets. It will improve trace-ability and increase identify-ability within the supply chain. Device recalls will be easier as will assessment and evaluation of performance.

As medical device manufacturers, Crescent Industries serves the Medical, Pharmaceutical, Dental, Defense, Safety, Electronic/Electrical, Aerospace, OEM/Industrial and Consumer industries by manufacturing a diversity of high quality plastic components and offering an integrated single-source solution for every customer. To learn more about Crescent Industries capabilities, please call 1-800-411-3844 or visit our website

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