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 by POLITICO Morning eHealth, in “FDA Guidance Could Improve Cybersecurity.”
Following is an excerpt:
“We have been sorely in need of this guidance for years, and are delighted to see it,” adds Bradley Merrill Thompson, an attorney with Epstein, Becker and Green. He was disappointed the guidance does not include combination products that involve the devices and drugs branch of FDA, however, and said there was still a fair bit of imprecision in the guidance. “I realize that in many instances, the specific facts matter very much,” he said, but “when the government has this much trouble stating specifically what is required, it suggests that the government should not be too punishing when companies make a decision in good faith with which the agency disagrees…. I think FDA needs to offer some leniency to manufacturers to continuously improve their products without onerous burdens.” He called for FDA to be “open-minded” in reviewing comments on the draft.