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Helpful Design Guidance, or Stealth Regulation?

Medical Device & Diagnostic Industry
| MDDI Article Index

Originally published July 1996

Last March, FDA released two important draft guidances on design, entitled "Design Control Guidance for Medical Device Manufacturers" and "Do It by Design." These are both important documents that everyone involved in device design should read, in part because they clarify FDA's expectations, but more significantly because they both offer useful guidance.

With things as they are, FDA would be challenged to release instructions on tying your shoes without becoming enmeshed in controversy. Unfortunately, the release of the design guidances has generated a lot of negative publicity without much attention to the truly helpful aspects of these documents.

In part, this is FDA's fault. In the Federal Register notice announcing the release of the drafts, the agency stressed that they do not "bind FDA or device manufacturers in any way." But this one statement is not enough. Fear that guidances are really stealth regulations is perennial in the industry. It's no surprise that the Health Industry Manufacturers Association should find the design control guidance "extremely prescriptive." No doubt a majority of industry shares HIMA's suspicion that FDA hopes to "use the guidance document as a means to include details that it was unable to write into the regulation."

Given this climate, FDA would do well to take HIMA's suggestion that it include a disclaimer in the design control guidance itself, stating that the recommendations are nonbinding and are not adjunct regulations. But beyond this, the agency would be well advised to recast the somewhat intimidating regulatory style of the design control guidance into the less intimidating, more readable approach of "Do It by Design." Not only would this change help dispel fear of closet regulations, but it would also make the valuable information in the guidance more widely accessible.

For the fact is, both of these guidances are extremely helpful. In producing them, FDA deserves great credit along with the inevitable criticism.

Anyone mystified by the handful of paragraphs on design control in the forthcoming revised GMP regulation will find the design control guidance a good starting point for enlightenment. The 35-page document comprises 11 explanatory sections keyed both to paragraphs of the new GMP and to subclauses of ISO 9001. The draft has its share of mistakes (such as calling the design history file a device history file), but these will doubtless be corrected in the final version.

To my mind, "Do It by Design" is an even more impressive document. Unlike the huge majority of government documents, this primer on human factors engineering is well written and easy to read. In its 53 pages, it offers an introduction to usability engineering, a comprehensive overview of issues involving the user interface of devices, and a helpful discussion of ways to conduct usability engineering in your company.

The final versions of these guidance documents are due to be released late this summer. If you have anything to do with device design, I urge you to get copies. They will be available from FDA as well as from Canon Communications, publisher of MD&DI magazine. For more information, feel free to call me at 310/392-5509 or E-mail me at [email protected].

John Bethune

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