Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “Device Expert Says FDA’s CDS Guide Revision Could Raise Legal Issues,” by Beth Wang. (Read the full version – subscription required.)
Following is an excerpt:
A medical software industry lawyer called out what he sees as “absolutely horrible” and “legally wrong” language in the revised version of FDA’s clinical decision support software (CDS) draft guidance, which clarifies which CDS tools under the provisions of the 21st Century Cures Act are no longer classified as medical devices and thus are not regulated by FDA. In one new section, FDA makes the distinction between software that helps in clinical decision-making and software that is used to drive clinical management, the latter of which the agency says will still be regulated as a medical device. The device expert says FDA’s distinction lacks substance and will most certainly raise legal issues. …
Medical device lawyers voiced significant complaints about the draft, saying it didn’t adopt a risk-based enforcement approach, failed to provide meaningful examples and explanations of regulated and unregulated software, and was unclear when it came to the criteria for determining when CDS will be regulated.
One of those critics, Bradley Merrill Thompson, member of law firm Epstein, Becker & Green and general counsel for the CDS Coalition, told IHP on Thursday that the revisions represent small steps toward progress.
However, as he dug deeper into the revised draft guidance, he found one section that gave him serious pause and that he believes will raise legal issues for FDA.
On page 14, the agency states that software as a medical device (SaMD) functions that drive clinical management are not CDS as defined in Cures, and it quotes the International Medical Device Regulators Forum’s description of SaMD that drives clinical management.
According to IMDRF’s framework driving clinical management infers that the information provided by the SaMD will be used to: aid in treatment by providing enhance support to safe and effective use of a medical device; aid in diagnosis by analyzing relevant information to help reduce risk of a disease or condition; and triage or identify early signs of a disease or condition.
FDA says such SaMD functions are not CDS because “they go beyond supporting or providing recommendations to [a health care provider], patient, or caregiver.” Thompson argues that FDA doesn’t provide legal support for this statement.
“Essentially FDA is saying that ‘to guide’ clinical decision-making -- which is the definition of ‘driving clinical management’ -- is somehow fundamentally different than to ‘provide recommendations’ for clinical decision-making,” he says. “That’s a distinction without substance. ‘Guiding’ clinical decision-making and ‘providing recommendations’ for clinical decision-making are the same.”
The lawyer believes FDA is trying to keep software companies under its regulatory oversight and is out of line in doing so. In doing so, the agency has made this version of the draft worse than the previous version, Thompson says.
“FDA is way in left field here, and they are trying to keep software companies from escaping FDA regulation by being transparent. This will not stand legal scrutiny,” he says.
Apart from that, there were some changes Thompson is pleased with, although he wishes FDA had gone further.