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FDA: medical device saved a complete cycle of control, despite the shutdown

Reports of strong reducing control food from the of Administration on control over foodstuff and medicines (Food and Drug Administration — FDA) because of the shutdown has excited many, especially users of medical devices — will not affect whether the problem with the government and their FDA?

We are also continuing to conduct for-cause inspections of facilities devices when the agency believes an imminent threat to life or health exists, and working to bring back online surveillance inspections of high-risk devices as we have already announced for foods.

— Scott Gottlieb, M. D. (@SGottliebFDA) January 11, 2019

Today the head of the FDA, Scott Gottlieb, admitting that got this has a lot of issues, said that in respect of the scope of medical devices, the Agency continues to fulfil all its obligations in full.

Scott Gottlieb: our employees carry out this important work — even in these difficult times

Gottlieb said that his staff, as usual, ensure the safety of the devices both before and after their release to the market. The Agency is continuing to take all signals of adverse events with medical equipment. “If we find problems, we can and will act to protect Americans from imminent threat to health,” said Scott Gottlieb.

Also continuing the processing and analysis of reviews on the medical products of high and medium risk and to take necessary measures for those that pose an immediate threat to human life.

In Tvittere the head of the FDA wrote today that the Agency continues to verify the devices when the Agency believes that there is a direct threat to life or health. He also noted that the FDA will try to move to online mode, as it did with checks products: “We are working to renew online inspection supervision of high-risk, as we have already announced the food.”

Gottlieb commended civil and professional qualities of its employees, “who perform this important work — even in these difficult times”.





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