FDA Shutdown Insurance

What do you do to protect your company in the event the Food and Drug Administration (FDA) has ordered or demanded a product that your company sells be sequestered, banned, recalled or withdrawn from the stream of commerce?

You may need an insurance product to cover your financial loss as a result of your company not being able to sell their product because of a regulatory shutdown by the FDA.

Those that qualify for coverage include:

  • Medical device manufacturers and their suppliers who are regulated by the Food and Drug Administration (FDA).
  • The product is presently the stream of commerce and generating income for the insured.
  • There are contractual relationships in place requiring the production and delivery of your product.

Coverage benefits:

  • Reimbursement of actual financial loss sustained by the insured.
  • Loss of profit.
  • Extra costs and expense related to purchasing, handling, storage, transportation or sales of your products and/or replacement.
  • Legal expenses incurred to minimize loss of profit.

Oswald offers a proprietary FDA insurance product. Please contact me to discuss further.