FDA 483 Feedback Draft Guidance

In yet another move to help the medical device industry, the FDA released draft guidance on how to request and receive informal feedback as to whether a company’s response to a nonconformity finding (form 483) is sufficient. While some may view the relationship between the FDA and device manufacturers as an adversarial one, it doesn’t need to be. In truth, the FDA just wants what we all want: consistently high-quality products that are safe and effective. This latest draft guidance demonstrates that far from the being “out to get” device manufacturers, the FDA wants to help manufacturers to achieve that goal for the betterment of everybody—including the companies themselves!

While receiving a form 483 may feel like getting chewed out by your parents, it really is an opportunity for growth and improvement, and meeting FDA requirements is often a value proposition in itself: better design and manufacturing improves yields and reduces rework, which ultimately improves a company’s bottom line. Reducing the risks a product has to users and patients reduces the likelihood of lawsuits, which also improves a company’s bottom line. Designing products to be user-friendly gives users a more favorable impression of the product and company while reducing use error—a double bonus! These are just a few examples of how meeting regulatory requirements can ultimately help a company long-term. Ultimately, a company can choose to begrudgingly do the bare minimum to “get the FDA off its back”—focusing on the short-term cost of the extra work to reach compliance—or the company can focus on the longer-term benefits that compliance brings and choose to really invest in self-improvement, take the 483 findings to heart, and come out on the other side with better, less risky products.

Here at Realtime, we prefer to think long-term.

Our team of engineers has decades of medical device experience and believes that while doing things right the first time is the best option, if a deficiency is found, it’s better to address it head-on than to try to sweep it under the rug. Like the FDA, we want to help you. Call us at 972 985-9100 and let us help you design your product to be consistently safe, effective, and pass FDA muster the first time—and every time.