The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs

CDRH Priorities Focus on Data, Quality

April 7, 2017

The FDA’s device center has tripled the number of staff with quality credentials to conduct on-site quality training and inspections.

The center had aimed to boost staff by 10 percent, but it ended up with a 300 percent increase, according to a report.

One of CDRH’s top priorities is the National Evaluation System for Medical Devices (NEST), which gathers real-world evidence to support regulatory decision making.

The agency has acknowledged that some data may lack rigor compared to data collected in clinical trial settings, but said it may help support approval decisions. CDRH expects to release final guidance on this issue in 2017.

CDRH had set a goal of collecting data from 25 million patient records by the end of 2016, but reported it actually gained access to more than 28.6 million patient records via clinical registries, claims data and electronic health records. To gather the evidence, the FDA struck deals with 14 device registries earlier this year.

The Case for Quality initiative is another top priority for the center. Launched in 2011, the initiative aims to elevate the focus of medical device stakeholders from baseline regulatory compliance to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes. As part of the Case for Quality initiative, the agency partnered with the Medical Device Innovation Consortium (MDIC) and the Capability Maturity Model Institute to develop a voluntary third party program using quality metrics to assess quality.

The partners are working with three device manufacturers to develop a proof-of-concept voluntary pilot program that will report back in 2017.

The FDA’s Quality System Regulation requires devicemakers to develop and maintain four files of information related to design, production and overall quality system. Order Device Documentation for a detailed guide that will help you understand each element and their relationships with each other, as well as guidance on how to develop the files.

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