CDRH Sees Customer Satisfaction as a Driver of Innovation, Good Regulation

Regulatory NewsRegulatory News | 16 June 2014 |  By 

The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) device regulatory branch, has a question for industry: How have we helped you lately?


It's a bit of an odd question without context.

In February 2014, CDRH launched a new document, CDRH 2014-2015 Strategic Priorities, in which it said the device center would be focusing on three things in 2014: strengthening clinical trials, balancing pre- and post-market data collection requirements so as to expedite approvals, and trying to "provide excellent customer service."

The last one seemed a bit out of place among the lofty goals set by the first two, but CDRH said that it was part of an overall strategy to make the US "the country of first choice" for companies looking to bring new technologies to market.

Right now, many of those companies go to other countries, such as Europe, where the path to market (though not necessarily government reimbursement) is seen as being faster than it is in the US.

And creating a favorable climate for innovation involves making sure that regulators are responsive to not only the needs of innovators, but their questions as well.

As explained by FDA:

"Excellent customer service means understanding and addressing, as appropriate, stakeholders’ and colleagues’ needs through active listening, problem solving, seeking out the ideas of others, explaining the rationale for our decisions and requests for information, learning from our mistakes, and doing our best. Providing excellent customer service improves our interactions with stakeholders and colleagues and supports better regulatory outcomes, thereby improving patient health."

Good customer service, FDA continues, "requires identifying and meeting our customers' needs, as appropriate, while achieving our mission and vision.”

Accordingly, FDA has set lofty goals for its customer satisfaction ratings, hoping that at least 90% of customers will have a satisfactory interaction with the agency by the end of 2015.

Satisfied With CDRH?

For now, though, it's looking to end 2014 with at least a 70% satisfaction rating.

So, FDA is now asking: How has CDRH helped you lately, and was its response to your satisfaction?

The center has released a new "CDRH Customer Satisfaction Survey," asking members of industry how satisfied they were with their customer service, and then drilling into the details of those interactions, including the department involves, the demeanor of the CDRH employee, and even soliciting ideas for improvement from the respondent.

The results from the surveys will be posted monthly starting in August 2014, CDRH said in a statement on its website.


CDRH Customer Service


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