CleanZone: FDA actions prompt heightened awareness of 510(k) compliance


ROCKVILLE, MD.-Recent warnings and guidance by the Food and Drug Administration (FDA; are sending a strong message to medical device manufacturers about the importance of submitting FDA 510(k) premarket notification when introducing new products.

The FDA issued a nationwide alert in early February concerning preloaded syringes manufactured by start-up IV Flush, LLC of Rowlett, Texas, believed to contain either heparin or sodium chloride intravenous catheter flushes. Bacterial infections linked to the syringes’ contents can cause mild, flu-like symptoms, but could be life-threatening for children and adults who require catheters or intravenous lines.

IV Flush and its distributor, Pinnacle Medical Supply, voluntarily recalled the syringes because they lacked proper FDA clearance for marketing. The FDA requires that companies or individuals planning to introduce a device into commercial distribution submit a premarket notification-510(k)-at least 90 days before commercial distribution begins.

A report by the American Society of Health-System Pharmacists ( indicates that IV Flush was not aware it needed a 510(k) before distributing its preloaded syringes, which were prepared in a Class 100 cleanroom.

“Noncompliance or regulatory violations will always be found in the industry, as no one company is totally free from not having something found,” says Ken Christie, senior director of consulting services at VTS Consultants (Westborough, Mass.; But he adds, “I think the issue of how companies address the documentation problems, how the investigation is handled, and whether upper management is adequately made aware of any quality issues are the biggest challenges for companies to be compliant with the regulatory expectations.”

In another 510(k)-related issue for manufacturers, the FDA has issued draft guidance, in conjunction with a Federal Register proposed rule, recommending reclassification of automated blood cell separator devices operating on centrifugal separation principle intended for the routine collection of blood and blood components. The devices automatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and components.

The FDA is proposing that these automated blood cell separator devices be classified as Class II, or special controls. To provide assurances to the public for the safe and effective use of these devices, the FDA is identifying possible risks to the public associated with a new device’s intended use.

Once the guidance is final, companies that manufacture a blood separator device operating by centrifugal or filtration separation will be required to submit a 510(k) premarket notification, and will need to show that its device meets the recommendations of the final guidance or can document that it provides equivalent safety and effectiveness assurances.

The guidance recommends that device manufacturers file an annual report with the FDA for three consecutive years documenting anticipated and unanticipated donor-adverse events-including operator infection or injury, equipment failures, thrombosis, sepsis, and shock resulting from blood loss. Also, changes made to a blood-collecting device will require that a 510(k) be included in that report.

“The reporting of adverse device events summarized in an annual report will alert FDA to trends or clusters of events that might be a safety issue…These special controls, along with the general controls, should provide reasonable assurance of the safety and effectiveness of the device,” says the Agency in its draft.

Addressing the importance of device manufacturers following through on 510(k) notification, as well as documenting manufacturing problems, Christie says that companies often do not look at what effect the problems may have had on lots produced prior to its discovery, and after it was found and corrected.

“The intent here is to try to identify the endpoints of the problem. Otherwise, the safety of what was shipped to the public comes into question,” Christie explains. III


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