Originally Published IVD Technology June 2003
EDITOR'S PAGE
Keeping an eye on quality
Since establishing the quality system regulation (QSR) six years ago, FDA has added the inspection of design, servicing, and complaint tracking at IVD manufacturing facilities, and has adopted a whole new technique of inspecting the systems that are in place to produce quality products. For the most part, IVD manufacturers have made the necessary changes to put into place these quality systems and be prepared for FDA inspections.
Complying with the QSR has proven to be especially challenging for IVD manufacturers. They face all of the challenges encountered by other medical device companies, plus those involved in processing chemistries that are easily affected by various ambient conditions as ephemeral as changes in the season or even rough handling. Since many IVD processes are susceptible to becoming out of control, they require special efforts if they are to be kept under control. It is therefore imperative for IVD manufacturers to ensure they have established the proper quality systems.
The potential consequences for those IVD manufacturers that do not have the proper quality systems can be severe. If FDA determines through an inspection, investigation, or complaint that an IVD is, or may become, adulterated or misbranded, the agency may take several actions. These actions may include a warning letter to the manufacturer, the seizure of a product, an injunction of the firm, and even prosecution of the manufacturer.
Violating the QSR is a serious and ongoing concern, and IVD manufacturers are having to recall their products as a result. Such violations are costing them time and money, and risking getting them into trouble with FDA, because of failures in their processing. Even when such failures are not willful, manufacturers can get into trouble for not complying with the QSR. It only takes a small slip, a batch of reagent produced out of spec, or a poorly produced circuit board, for a manufacturer to have to recall a whole batch of its products.
IVD manufacturers have to deal with a number of processing technologies that could potentially get out of control. One of those processes involves the design and development of electronic components. In this issue of IVD Technology, author Steli Loznen discusses production-line safety tests for IVD electrical equipment. His article, "Safety Tests During the Design of IVD Electrical Equipment", examines various safety factors that IVD manufacturers should take into account when developing electrical equipment to make sure that various electrical-related hazards do not occur.
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