Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in Pharma & MedTech Business Intelligence’s The Gray Sheet, in “Accessorize at Your Own Risk: Draft Guidance Clarifies Regs for Device Add-Ons,” by Ferdous Al-Faruque. (Read the full version — subscription required.)
Following is an excerpt:
Bradley Thompson, who heads the mHealth Regulatory Coalition, says the draft leaves much to be desired for the companies he represents. The document does not address several points that were highlighted by the industry coalition in advance of the draft guidance, he says.
In particular, FDA does not specifically clarify the accessory status of general purpose hardware that is sold with preloaded medical software, as requested. “In that instance, we do not think that the general purpose hardware or software should be deemed an accessory even though commercially it is being combined before the sale,” Thompson said. “We’d like to see FDA clarify that in writing.” …
“These days, it is also more common to make claims of interoperability, frankly and we want to see such claims increase,” Thompson said. “But we also want to make sure that a mere claim of interoperability doesn’t lead an item to being characterized as an accessory to a medical device.”
“We proposed to FDA that they use guidance to develop categories of accessories that would be unregulated through enforcement discretion, to be followed up by rulemaking through which FDA would formally declassify these devices,” he said. …
Instead, Thompson argues, the agency has simply pushed the burden on to industry by recommending use of the de novo process.
“Unfortunately, as often happens in this world, the whole issue seems to have come down to money,” he said. “FDA does not want to shoulder the burden unilaterally to reclassify these accessories. They want industry to put together submissions that include all of the data necessary to support the reclassification.”
