FDA Tracks Critical Device Supply During Puerto Rico Hurricane Recovery
Continuing recovery efforts in Puerto Rico have US FDA focused on life-sustaining devices or those only made on the island. Meanwhile, manufacturers including Baxter, Zimmer, J&J and Abbott report varying impacts from the storms.
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While several device companies said they expected only minimal financial impact from the destruction of Hurricane Maria in Puerto Rico (as well as from Hurricanes Harvey and Irma in Texas and Florida) some firms, including Baxter and Integra, anticipate losses of tens of millions of dollars, according to Q3 earnings reports.
Medical-product manufacturers in Puerto Rico took a major hit from Hurricane Maria, but some are slowly getting back up to speed as portions of the island's electrical grid go back online and additional generator power is deployed by device and drug companies, FDA Commissioner Scott Gottlieb told a US congressional panel Tuesday. But he warned that some facilities are "'sole-source" providers of devices and drugs, and that some longer-term government support may be needed to prevent future product losses.
Gottlieb At The Medtech Conference: US FDA Commissioner Talks About CDRH Innovation, Puerto Rico, LDTs And More
Check out the full video and read the highlights of US FDA Commissioner Scott Gottlieb's keynote address and Q&A from AdvaMed's 2017 Medtech Conference. Among the issues addressed: Gottlieb touted the agency's device center as the spark of innovation within FDA, and he provided a key update to the agency's digital-health regulation, his hopes for lab-developed test regulations and some substantive points on how industry should respond to the ongoing devastation in Puerto Rico from Hurricane Maria.