News about GMP/cGMP

23.07.2021

FDA: Push for more authority on device shortages

FDA: Push for more authority on device shortages

As part of the annual budget planning acting FDA Commissioner Janet Woodcock has addressed the problem of weaknesses in the medical devices supply chain and its overall dependence on foreign medical devices.


Regarding this, the FDA also demands more authority to ask manufacturers for input on potential shortages or information about production volume or their risk management plans. With this, a better oversight on any disruptions of the supply chain could be achieved.

Woodcock writes that “FDA needs expanded authority to obtain supply disruption notifications for critical devices any time there is the potential for a shortage”.

Along with this goes a $21.6 million investment for a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP) in the Center for Devices and Radiological Health (CDRH).


Source:

FDA’s Budget: Medical Device Supply Chain and Shortages Prevention Program


 

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