Device Manufacturer Receives Warning Letter Over Product Approval Snafu

The Sarasota, Fla.-based developer of an instant wound seal powder is fine-tuning its manufacturing process to resolve a U.S. Food and Drug Administration (FDA) warning letter that claims the product lacked a required approval.

Late last year, Biolife LLC launched WoundSeal, a topical powder that stops bleeding in seconds by forming an instant seal (or scab) over a wound. The seal is safe to leave in place until it falls off naturally, according to the company. The non-prescription, non-allergic powder is comprised of a hydrophilic polymer that pulls moisture from the blood and potassium ferrate, a substance that binds with proteins in the blood to quickly form a seal. In a Dec. 8 news release announcing the product launch, company executives claimed that WoundSeal had passed all FDA safety tests.

Indeed, the FDA has no qualms about the safety of WoundSeal. Rather, it is the approval process that concerns the agency; in its June 15 warning letter to the firm, FDA officials claim Biolife does not have “an approved application for premarket approval…or an approved application for an investigational device exemption.” The FDA also contends the product is misbranded.

Wound dressings such as Biolife’s typically do not need FDA approval before they are sold commercially. But since WoundSeal contains potassium ferrate—a drug—the FDA considers it a non-exempt medical device, according to the warning letter. Agency records show the FDA approved versions of WoundSeal’s predecessor, Pro QR (a sterilized product used in hospitals and clinics and later sold as BioSeal), in 2007 and 2009. WoundSeal is considered a non-sterile version of the same product and currently is sold through Walgreens drug stores.

“The change in sterilization represents a modification that could significantly impact the safety and effectiveness of a device and requires the submission of a new premarket notification,” the warning letter stated.

Biolife CEO Sam Shake, however, claims the company received conflicting information from FDA inspectors. In an interview with the Bradenton Herald in Bradenton, Fla., Shake said the company considered asking for approval of the non-sterile WoundSeal, but decided against it because it “would have taken months and months.” Challenging the FDA’s ruling wasn’t an option either, unless executives wanted to subject the firm to a lengthy (re: years-long) battle. In the end, Biolife bigwigs decided the simplest way to comply with the FDA’s wishes was to sterilize WoundSeal so it is identical to BioSeal. The privately held company has started shipping packages of WoundSeal to a sterilization facility about an hour away in Mulberry, Fla.

“It’s the flat-out right thing to do,” Shake said in the Bradenton Herald interview. “There’s no animosity here.”

The sterilization step adds a small amount of product development costs to WoundSeal, but Shake will not provide an estimate.

Besides manufacturing WoundSeal, Biolife operates and maintains blood plasma collection facilities throughout the United States and Austria. A subsidiary of Baxter International Inc., Biolife collects nearly 3 million liters of plasma annually.