MD&DI February 1997 Feature Article
FDA Makes Quality the Rule (continued)
13. CONCLUSION
Medical device manufacturers should consider the publication of FDA's quality system regulation an event of some importance--and perhaps even a cause for modest celebration. After many years of difficult work, the U.S. industry finally has a regulation that will bring its practices into line with quality system standards in use throughout the world, and thereby make it easier for U.S. companies to compete in the global marketplace.
As expected, the largest and most important change in the final regulation is the addition of design control requirements. These requirements have changed little since they were first
proposed in the agency's draft of November 1993. However, other sections of the new regulation underwent considerable modification up to the very end. For instance, the section on servicing requirements proposed in the 1995 working draft appears in the final regulation completely transformed. Also significant are the changes made to the section on nonconforming product, where wording was provided that will permit manufacturers to decide when an investigation is necessary. Another good move by FDA is the return to applying traceability requirements only to critical devices, which will allow manufacturers to continue using their current practices.
In many instances, the new regulation omits requirements even though the preamble says they are necessary. This is the case with the requirements for GMP training of employees. Although the preamble is only an advisory opinion from the agency, it can be used in legal proceedings to establish the intent of the regulation's requirements. Manufacturers should therefore familiarize themselves with the preamble and comply with the opinions expressed there.
Implementing the new quality system regulation will take time and money. According to FDA's figures, total costs of implementation are expected to be $81.9 million. Most of these costs will come from the implementation of design control requirements, which the agency says will cost $57.5 million. With such an investment at stake, manufacturers should have a strong interest in getting it right, and can be expected to devote a major portion of their time to doing so over the next six months.
Overall, FDA appears to have done a good job of addressing the concerns and comments expressed by industry throughout the process of formulating the final rule. As a result, the new quality system regulation is a better, more lenient, and more flexible regulation than either the November 1993 proposal or the 1995 working draft.
As industry may soon find out, however, flexibility can be a double-edged sword. Open-ended requirements can create a lot of opportunity for differing interpretations by FDA and by industry, and can make it harder, rather than easier for manufacturers to comply. In the preamble to the regulation, FDA has attempted to provide guidance that will minimize such instances. But as industry begins to work out the details, much more guidance will undoubtedly be needed.
