FDA Commissioner Scott Gottlieb, M.D. released a statement on the status of the medical device industry amidst the destruction left in Puerto Rico by Hurricanes Irma and Maria. He states that the medical product manufacturing presence in Puerto Rico is important for the economic well-being of the island and to the health of all Americans. There are currently more than 50 medical device manufacturing plants on the island, employing 18,000.  While they manufacture over 1,000 different types of medical devices, the FDA is monitoring 50 that are critically important to life-sustaining patient care.
The industry is facing the same basic challenges as other industries in Puerto Rico –a lack of power, connectivity, transportation, and clean water. Because manufacturers are running on generators, they have been unable to return to pre-hurricane production levels. They face difficulties in securing the various components critical to device development.
The FDA is working with these companies and their suppliers to restore production in Puerto Rico as soon as possible. Meanwhile, steps are being taken to mitigate the potential for shortages, including importing devices or allowing manufacturers to move production to alternate sites. Though the recovery process will take months, the FDA is committed to the people of Puerto Rico and the health of Americans.
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