DOJ Memo Could Offer Additional Defenses In Enforcement Actions
Industry should be cautious in interpreting a recent US Department of Justice memo stating DOJ wouldn’t take enforcement actions based on failure to comply with guidance documents alone, according to experts. But the document still could offer assistance to manufacturers fighting enforcement actions.
You may also be interested in...
Biden Admin Promises More ‘Aggressive’ Approach To False Claims Act Enforcement, Lawyers Say
Manufacturers may see a more forceful approach toward False Claims Act enforcement under the new administration, attorneys say.
US DoJ Memos May Hint At Enforcement Stepdown
The US Department of Justice has ordered its attorneys to ask for the dismissal of more whistleblower cases, and to avoid basing civil enforcement actions solely on guidance documents. Both could lead to fewer enforcement actions against device manufacturers.
MDSAP Audit Allows Emerging Firm To Expand Internationally
Blood-collection technology firm Tasso has been recommended for certification by MDSAP. The international qualification is part of a push to offer the company’s technology in countries such as Australia and Canada, CEO Ben Casavant told Medtech Insight.