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 Medical Device Daily, in “FDA Wins Kudos from Industry in Combo Product Good Manufacturing Practice Final,” by Mark McCarty.
Following is an excerpt:
Brad Thompson, who along with several other attorneys with Epstein Becker & Green had represented the Combination Products Coalition, told Medical Device Daily, “we are delighted to see this final guidance.” He said the final is a solid guidance document thanks in part to the fact that the agency “has been incorporating into its guidance not only answers to questions, but case studies that illustrate how FDA approaches these issues.”
Thompson said the final guidance clarified the circumstances in which the products in a kit cause that kit not to be considered a convenience kit. He explained that when a kit includes products “otherwise modified from the independently marketed product,” the kit is no longer a convenience kit. “This slightly revised language seems to indicate that the act of kitting alone would not ‘modify’ the product,” he said, adding “it appears the intention is that such modification pertains to changes to packaging or labeling of the independently marketed product.”
The final guidance also clarified that manufacturers will not have to routinely submit GMP information prior to clearance of 510(k)s, Thompson said, and that the final version drops the use of the word “sponsor” so as to eliminate confusion as to the facilities that have to demonstrate compliance with GMPs.
“There are, of course, a few areas where we have lingering questions, and we look forward to exploring those issues with FDA,” Thompson said, adding, “I think the agency is planning to do educational programs through some of the professional societies like RAPS, which will present an ideal opportunity for some dialogue and further understanding.”
“On the whole, we are pleased” with the final guidance, Thompson said.