John Serio was featured in the article, ‘FDA Wants To Make Permanent COVID-19 Supply Chain Guidance To Prevent Product Shortages,’ which was published by Medtech Insight on January 11, 2022. The article discusses the US Food and Drug Administration’s push to keep a guidance in place that requires medtech manufacturers and distributors to notify the agency of a product shortage during a public health emergency.
John Serio, shares that “the guidance allows companies and the FDA to work together to prevent shortages of critical medical products in future health emergencies and suggests that those that don’t company by penalized.” “What the agency wants to be able to do in responding to emergencies is make sure that in the event a manufacturer is having a supply problem, a regulatory problem, whatever problem, that they can then prioritize maybe inspections of other plants, approvals of other regulatory applications, to address the gap of a discontinuance of a medical device.”
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