Joel Gorski: A Renewed Appreciation for Our FDA

June 21, 2013

Regulations

I recently participated with medical device industry colleagues in the writing of a magazine article about the industry in BRIC (Brazil, Russia, India, and China) countries. In preparing for the article, several events in Russia caught my eye and seem worthy of sharing.

The Russian health agency responsible for medical devices, the Federal Service for Surveillance in Healthcare, aka Roszdravnadzor, published on Dec. 17, 2012, regulations for medical devices (Decree No. 1416—Regulatory Framework for Medical Devices), some of which were supposed to become effective Jan. 1, 2013. As is common with the introduction of new regulations anywhere, some were a bit ambiguous and caused concern, and some ancillary documents referenced by the new regulations have yet to be released, making compliance difficult, if not impossible.  However, something more serious arose—allegations of bribery by senior officials within Roszdravnadzor. It was reported that the Russian government plans to assemble a new team of personnel within that regulatory agency. The head of Roszdravnadzor resigned effective March 7, 2013.  Another consequence is that there is now an ongoing review of all past medical device registrations. Although it is not entirely clear, I suspect this is occurring as there is suspicion about the safety and efficacy of the previously registered devices in light of the bribery allegations. At this time, all new medical device registrations are on hold within the Russian agency.

Can you imagine how all of this adversely affects the confidence of the Russian population in the medical device regulatory system in Russia? How about the effect this has on the successful delivery of healthcare across their country to those in need? What is the outlook in this area given this situation? All very complicated questions that are difficult, if not impossible, to answer.

The situation in Russia prompted me to think about the medical device regulatory system in the United States and has left me with a renewed appreciation for our Food and Drug Administration (FDA) and its Center for Devices and Radiological Health. While what we do in the United States may not be perfect, I sure feel a lot more comfortable here than I would if I were over there.

Joel Gorski, PhD, is director of research and development with NAMSA.

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