Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg BNA Medical Devices Law & Industry Report, in “FDA Outlines When New Clearances Are Needed for Existing Devices,” by Michael Williamson.
Following is an excerpt:
However, Thompson said the guidance isn’t precise. In many instances, the FDA inserts the word “likely” to qualify statements of whether a 510(k) is required when a device company changes a product’s software, he told Bloomberg BNA. This imprecision might be interpreted to sweep many software modifications into needing a new 510(k), Thompson said.
“To be clear, I would not want them [the FDA] to simply strike out the word ‘likely,’” Thompson said. “I’m not in favor of certainty for the sake of certainty. I realize that in many instances, the specific facts matter very much. My only point is that this guidance is intended to clarify the requirements for an industry that is probably not unified in its approach to making these decisions, and is meant to give fair warning to industry before enforcement of this legal requirement.”