FDA gets expanded Power to prevent Medical Device Supply Disruptions
Due to the Corona pandemic, there were supply shortages of medical device products in the USA. To get these shortages under control in the future, the FDA gets expanded power. What is planned?
First of all, financial resources are being allocated for a supply shortage prevention program. That's as much as $21.6 million the U.S. has budgeted for the Resilient Supply Chain and Shortages Prevention Program (RSCSPP) in fiscal year 2022. The program runs in conjunction with the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The focus is on strengthening the nation's supply chains, including becoming less dependent on medical devices manufactured outside the United States. For that purpose, preventive measures need to be taken. For example, potential supply chain disruptions of medical devices need to be identified and the continuous monitoring of supply chains needs to be established to be able to intervene quickly. To this end, FDA capabilities are to be further strengthened.
Please see the FDA Website to find further information.
Related GMP News
18.01.2024Notified Body Survey on Certificates and Applications under the Medical Devices/IVD Regulation
18.01.2024Update of the EMA Q&A document on Combination Products
18.01.2024MDCG Guidance on the Responsible Person according to Article 15 MDR Updated
07.11.2023Harmonisation Efforts of the CDRH
07.11.2023Medical Devices Warning Letter Statistics for Fiscal Year 2023
07.11.2023FDA Publishes Lists of Planned Medical Device Guidances for Fiscal Year 2024