A company marketing several medical devices intended to be used in combat situations has been cited by the US Food and Drug Administration (FDA) for marketing one without having sought approval from the agency and manufacturing numerous others in violation of current good manufacturing practices.
In a warning letter released 9 May, FDA said Virginia-based manufacturer H&H Associates does not have "an approved application for premarket approval in effect" pursuant to federal regulations for its Emergency Cricothyrotomy Kit.
"Specifically, the H&H Emergency Cricothyrotomy Kit requires 510(k) clearance as it is labeled as a "sterile, single use kit for the performance of an emergency cricothyrotomy," said FDA in a statement. "Documentation of performance validation, biocompatibility, clinical validation, and usability would be reviewed under the 510(k) clearance review paradigm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed."
The agency further noted the seriousness of H&H's failure to obtain a PMA for its Emergency Cricothyrotomy Kit, calling it a "significant violation."
The agency also warned H&H in its warning letter about numerous violations of current good manufacturing practices at its manufacturing facility, including inadequate design and quality controls, failure to monitor production processes, failure to evaluate complaints, failure to conduct quality audits and failure to explicitly delegate responsibilities to specific staff members.
While H&H sent a response to FDA, the agency indicated the response to its warning letter was deficient, saying the company "did not provide evidence of documentation and implementation of the developed procedures."
H&H's website says the company operates primarily with military-end consumers in mind, and its Chest Tube Insertion Kit remains on its website with a disclaimer saying the device is not intended to be sold to non-federal or non-military organizations.
"Sale of these certain products to all other parties requires a Medical Device Authorization," explains H&H in a statement. "This authorization is required to ensure that only those persons who are trained and are authorized to use the product sold by H&H."
While H&H appears to have taken down its Emergency Cricothyrotomy Kit from its list of available products, other products, including its Chest Wound Kit, Damage Control Surgery Wound Kit and Lateral Canthotomy Kit all carry the same disclaimer as its Chest Tube Insertion Kit.
FDA Warning letter - H & H Associates 4/30/12