FDA News

Shelhigh and FDA Reach an Agreement

Shelhigh announced that it has reached a no-fault settlement agreement with the U.S. Food and Drug Administration (FDA) that provides a clear path to the resumption of operations at Shelhigh, including product shipment.

I am extremely pleased that the FDA and Shelhigh were able to reach a settlement that will permit us to resume shipments of our life-saving
products to patients around the world," said Dr. Shlomo Gabbay, Chief
Scientific Officer for Shelhigh.

The FDA acknowledges that it did not mandate a product recall, Shelhigh did not conduct a recall, and no product recall is required by the
settlement just announced.The agreement calls for independent experts to inspect and certify that
Shelhigh's manufacturing processes are in substantial compliance with Federal regulations. These independent inspectors have already begun their review and the firm anticipates that any required changes will be easily implemented. Upon completion of the experts' certification, the FDA will conduct normal inspections to confirm that the requested changes were made.Importantly, this approach will provide the fastest means for Shelhigh to resume product shipment.

This was not an agreement ordered by the court, but rather a mutual no-fault settlement that the court agreed to sign so that FDA and Shelhigh
can resume good relations, and Shelhigh can resume delivering its life-saving products. Shelhigh is pleased to announce that FDA declared,
FDA did not invoke the Federal Food, Drug, and Cosmetic Act to mandate that Shelhigh recall its devices, and Shelhigh did not conduct a recall ofits devices."

Shelhigh has always been committed to maintaining a good working relationship with the FDA, while providing its life-saving products to
patients in need," said Dr. Gabbay. "As is well-documented, Shelhigh's track record of providing effective and revolutionary products is
extraordinary, and we are pleased to demonstrate that our manufacturing process is exact and complete, and in full compliance."

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