Photo of William A Hyman, ScD

William Hyman

On April 24, 2015, the US Food and Drug Administration (FDA) issued a Warning Letter to a replacement battery supplier that has raised some interesting issues about replacement manufacturer responsibilities and possibly battery quality.1 It is likely that at least some of these issues are also applicable to other replacement part manufacturers.

The manufacturer that received the Warning Letter specifically labels its batteries for medical device use. From a regulatory perspective, this situation is different from one in which a supplier is selling generic batteries and the buyer is determining whether or not they are suitable for a particular medical device.

One of the overriding issues outlined in the Warning Letter is that according to the FDA, a replacement battery falls under the same regulations as the device for which it is intended. As a result, the battery supplier is required to meet the same level of FDA compliance as the device itself. Thus, a battery would be subject to only registration and listing for a Class I device, to 510(k) clearance for a non-exempt Class II device, or to PMA approval for a Class III device. Moreover, for Class III the FDA asserts that the device PMA holder—not the battery maker—would have to seek approval of the battery via a PMA supplement. This seems highly unlikely to occur in many cases, since the PMA holder in general wants you to buy its battery, not someone else’s.

Since the battery maker discussed here was deemed subject to FDA regulation, then all the FDA regulatory requirements in addition to those concerning marketing also apply. The Warning Letter found the manufacturer wanting in a number of general and particular areas, including not being registered as a medical device manufacturer—which, interestingly, was remedied during the FDA’s inspection with an instant online registration. However, the company was still cited for not “listing” its products. The absence of proper marketing permission was also said to render the batteries “misbranded.”

Other alleged failings included neglecting several specific regulatory requirements, including design controls, incoming component inspections, finished device acceptance procedures, complaint handling, corrective and preventive maintenance (CAPA) procedures, medical device reporting (MDR), proper equipment inspection and calibration, and a lack of management controls. These kinds of FDA–specific failings are hardly surprising for a company that didn’t consider itself subject to FDA jurisdiction. In some instances, it may have had similar procedures in place, but not those specifically required by the FDA.

None of the cited shortcomings necessarily mean that there was anything wrong with the batteries, and there was no corresponding recall. In fact, Warning Letters are rarely linked to recalls, since the issues they address are typically procedural ones rather than actual product defects. Most Warning Letters, including this one, result from FDA inspections, which mostly deal with specific aspects of the FDA’s Quality System Regulations (QSR). But QSR issues are not the same as product issues.

In this regard, I once asked a senior FDA official whom I knew, “Do the Quality Systems Regulations lead to quality systems that then lead to quality products?” His answer, in the spirit of my question, was, “That’s our position and we are sticking to it.”

Although this response was meant to be partly humorous, there is actually very little evidence of the effectiveness of FDA regulations, or indeed any safety-related standards, on improving safety. This is largely because there is often no relevant “before” scenario with which to compare, even if such a comparison were undertaken. The new rule from the Centers for Medicare and Medicaid Services (CMS) and The Joint Commission (TJC) on following the manufacturer’s maintenance requirements, at least for certain devices, is a case in point here. Since there was no evidence of a maintenance issue before the rule, there can be no indication that the rule improved anything, other than perhaps the manufacturer’s maintenance-related income.

Another core issue raised by the Warning Letter that affects all non-OEM replacement parts is the degree to which the replacement part is identical, seemingly identical, or otherwise similar to the original part. Analysis of this question should always be well-documented. Risk management is also applicable here, in terms of anticipating the consequences of a replacement part failure.

Another issue, newly illustrated by this Warning Letter, is the need to perform due diligence to determine if a parts supplier is FDA-compliant where applicable. Since a curiosity of Warning Letters is that they do not directly stop sales, customers could purchase batteries while the manufacturer is under such a warning. If noncompliance ever became an issue, the customer might have some explaining to do. Using non-OEM parts could also become a problem with devices that must adhere to the CMS/TJC mandate to follow the manufacturer’s maintenance requirements, especially when the OEM specifies, as many do, to use only its own parts.

William A Hyman, ScD, is professor emeritus, Biomedical Engineering, at Texas A&M University, College Station, Tex, and adjunct professor of Biomedical Engineering at The Cooper Union, New York.