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U.S. FDA Warns Devicemaker Over Leasing 510(k) Clearances

April 10, 2015

An otherwise routine U.S. FDA warning letter includes a firm warning against leasing 510(k)s.

The FDA’s Florida district office issued the nine-observation warning letter to Craftmatic Industries on Feb. 17. The letter says Craftmatic’s staff told investigators that the company was leasing its 510(k) to other companies to manufacture and distribute their own therapeutic adjustable beds.

While a 510(k) may be bought, sold or transferred, multiple companies may not make the same device under the same 510(k), the FDA states emphatically. Instead, a company wishing to license a 510(k) for a device still in production must obtain its own 510(k) clearance. This ensures that devices on the market exactly match the device described in the 510(k), the agency says.

This contrasts with a company selling its products to distributors for marketing under the original 510(k, because only one product is being manufactured, the agency adds.

Issue Rarely Addressed

Attorney Alan Minsk with Arnall Golden Gregory says the issue has come up before, but has rarely been clarified by the FDA.

This is the first time he’s seen a policy statement in writing, Minsk says, and while the letter was issued by a district office, he believes it was intended for the entire industry as CDRH typically signs off on district warning letters.

In addition to the 510(k) leasing, the warning letter recounts quality-related violations (IDDM, April 7). Craftmatic could not be reached for comment.

View the warning letter at www.fdanews.com/04-13-15-craftmatic.pdf. — Elizabeth Orr