The US Congress has passed the Safeguarding Therapeutics Act to stop imports of fake medical devices.
Legislation approved by the US Congress to thwart the importation of counterfeit devices is expected to be signed by President Trump this week.
H.R. 5663, the Safeguarding Therapeutics Act, was originally cosponsored in the House by Reps. Brett Guthrie (R-KY) and Eliot Engel (D-NY). It is aimed at capturing a wide array of counterfeit medical devices and supplies, including fake glucose tests, blood pressure cuffs and syringes, and preventing them from being sold within the US
The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.
The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.
States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.
