FDA: With Half of Medical Devices Imported, Tracking is Harder

With half of all medical devices in the United States imported, it is difficult to ensure that all players along the supply chain meet their safety and quality responsibilities, according to a report by the Food and Drug Administration.


The FDA report, Pathway to Global Product Safety and Quality, calls for international partnerships among regulators, a worldwide data information system for regulation and the allocation of agency resources based on risk.


Already, the FDA's PREDICT system uses data on the entire production cycle of a product to target risks before they enter the country, allowing investigators to focus on the highest-risk devices.


Read an executive summary of the FDA report on medical devices.


Related Articles on Medical Supply Chain:

Using Surgeon-Owned Distribution to Change an Unsustainable Trend

Medical Equipment Prices Virtually Flat in April-May, Federal Data Shows

6 Supply Chain Mistakes That Drain an ASC's Budget


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