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’s Medical Device Reporter, in “Regulatory Agenda Includes Updates on Combo Products, Labeling Rules,” by Michael D. Williamson.
Following is an excerpt:
Perhaps more than other proposals, the combination product proposed rule, if published as a final rule, is likely to “trigger substantial changes” in companies’ standard operating procedures and the software systems firms use to manage adverse events, attorney Bradley Merrill Thompson told Bloomberg BNA June 8.
Thompson, who leads the Combination Products Coalition, an industry trade group, also is an attorney with Epstein Becker & Green P.C. in Washington. …
Thompson had heard that the combination product rule “had slipped in priority,” he said, adding, “I’m not entirely sure why, other than FDA simply has other things that they view as more important.”
The longer the FDA delays this rule, “the longer industry will necessarily need to wait to make the changes,” Thompson said. “That’s not a ‘threatening’ comment: I’m just pointing out that no one can afford to change complex software multiple times, so most companies will need to wait until they know what the final rule says before investing in updates.”