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 the Bloomberg BNA Medical Devices Law & Industry Report, in “FDA to Drug/Device Combo Makers: Wait for Reporting Guidance,” by Alex Ebert. (Read the full version – subscription required.)
Following is an excerpt:
Combination product manufacturers should delay software and training investments to meet new standards for post-market reporting of deaths, injuries, and device malfunctions, an FDA official said. …
Even if the FDA produced a new form for the reports in December, the necessary software and IT infrastructure changes could take 12 to 18 months.
“It’s a rather substantial amount of time and money to change the software that companies use to report an adverse event, and there’s a lot of training involved,” Bradley Merrill Thompson, general counsel for the Combination Products Coalition, told Bloomberg BNA. Thompson said that on one hand industry was pleased with Weiner’s announcement but also said that expecting industry to implement new software and training for reporting in about half a year would be a difficult deadline for product makers.
