The president has signed a 2018 appropriations bill to cover costs at federal agencies until Sept. 30. It provides budget authority funding (not including user fees) for US FDA's device activities at $330m – the same as in 2017 – but gives a total boost of $135m to the agency, up to $2.9bn. The president warned Congress he signed the bill "only as a matter of national security," because it contains increases in military spending.
An omnibus spending bill package signed by President Trump March 23 gives US FDA a total funding increase of $135m for the balance of the 2018 fiscal year, for a total of $2.9bn, not including user fees. But specific device program funding would remain flat compared to 2017.
Some of the boost to FDA's budget, nonetheless, would impact device reviews
The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.
Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.
Proposed tariffs on semiconductors from President Donald Trump could significantly raise costs for the US medical device industry. Current domestic production cannot meet demand, spurring concerns about potential price increases for consumers and healthcare systems.
Members of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.
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.
