Why Don't CDRH Reviewers Always Greet You Warmly on the Phone? They Are Stressed, Says Former FDA InsiderWhy Don't CDRH Reviewers Always Greet You Warmly on the Phone? They Are Stressed, Says Former FDA Insider
At a conference session at Biomedevice at San Jose, president of CardioMed Device Consultants (Baltimore) Semih Oktay, PhD gave a broad overview of CDRH and FDA, drawing on his own experience at the agency as an expert mechanical engineer and scientific reviewer of cardiovascular devices.
December 7, 2011
At a conference session at Biomedevice at San Jose, president of CardioMed Device Consultants (Baltimore) Semih Oktay, PhD gave a broad overview of CDRH and FDA, drawing on his own experience at the agency as an expert mechanical engineer and scientific reviewer of cardiovascular devices.
Oktay explained that working at the agency can be very stressful and the salary opportunities are limited. The workload at the CDRH can be daunting, he explained. "They are dealing with more than 11,000 submissions every year," he said. Also consider the volume of investigational device exemptions that are submitted to reviewers, Oktay recommended. "[Reviewers] have 30 calendar days to review them," he added. On top of that, reviewers must go to frequent meetings and training events. "All of these things these guys are doing under limited salary. Imagine how much pressure they are under," he said. Oktay added that the stress level at the agency is the reason people in the industry often are not greeted warmly when phoning a reviewer at CDRH. And the workload combined with the limited pay is one of the reasons for high employee turnover at the agency.
This issue has been getting a fair amount of attention in recent years, as the agency has been increasingly criticized for slow review times, inconsistency, and other problems. Last year, senator Al Franken released a document explaining his thoughts on CDRH recruitment, arguing in the beginning of the document that:
While there are varied opinions on many Food and Drug Administration (FDA) issues, the good news is that everyone seems to agree on one matter: that FDA, and its Center for Devices and Radiological Health (CDRH) in particular, need to make some changes in workforce recruitment and retention strategies.
Advice for Medical Device Professionals on Dealing with FDA
Although I found the first-person perspective on Oktay's experience at the agency to be especially interesting—considering how frequently the agency is criticisized for inefficiency and lack of transparency, the bulk of his conference session provided background information about the industry and advice on how to best deal with CDRH. Here's a summary of one portion, which was designed to offer advice on how to get the most out of dealing with the agency:
Be up front about your proposed submission strategy. FDA does not like surprises, Oktay says.
Good record keeping is important—document all of your communications with FDA every e-mail, every phone conversation should be recorded and kept track of.
It is important that you deal with the appropriate FDA reviewing branch—do your homework, he advised. And make sure you communicate well with that branch.
Getting FDA interaction early is a key to your success, he said.
Honor the commitments you made with the agency. Try to make their lives easier; you need to have FDA staff as friends.
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