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# FDA Monitoring 50 Critical Devices Made in Puerto Rico
- URL: https://www.fdaweb.com/fda-monitoring-50-critical-devices-made-in-puerto-rico/
- Published: 2017-10-20T12:00:00.000Z
- Updated: 2026-09-14T22:57:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139923

Post-hurricane troubles in Puerto Rico are not unique to pharmaceutical manufacturers — FDA says it is paying equal attention to medical device makers on the island who are struggling to return production and distribution to pre-storm levels. In a 10/20 post-hurricane update, FDA commissioner **Scott Gottlieb** says there are currently more than 50 medical device manufacturing plants in Puerto Rico that employ about 18,000 people. “Collectively, they manufacture more than 1,000 different kinds of medical devices,” h says. “These include simple but essential products like surgical instruments and dental products as well as highly complex devices such as cardiac pacemakers and insulin pumps.”

Gottlieb says the agency is monitoring about 50 device types made on the island that are critical to patient care, with some made by a sole manufacturer, to prevent shortages. FDA is closely working with about 10 manufacturers, and they are particularly focused on blood-related medical devices, he says. One of the biggest issues is that the medical device manufacturers continue to run on generator power, which makes it difficult to return to full-capacity.

“In addition to these concerns,” Gottlieb says, “the medical device industry faces obstacles specific to the unique production requirements of each of these products. The device manufacturers have significant variation in the raw materials they require and the production processes they employ. These manufacturers face challenges in securing the various components critical to device development. These issues are exacerbated by the dependence on local subcontractors who provide much of the supplies needed for these unique manufacturing processes, but are facing their own challenges and shortages. This includes suppliers of components of a finished medical device or industrial gases, as well as tools that are critical to the production of devices.”

Additionally, Gottlieb says that if shortages occur, the agency is prepared to allow importation of devices from outside the U.S., or allowing manufacturers to shift production to alternative sites.