Exercising its power under the Safeguarding Therapeutics Act (STA), the US Food and Drug Administration has issued a final rule authorizing the agency to destroy medical devices valued at $2,500 or less that have been refused entry into the US.
FDA Implements Authority To Destroy Certain Medical Devices, Amends Final Rule To Provide Device Owners Prior Notification
The US FDA has issued a final rule allowing the agency to destroy some medical devices that have been refused entry into the US. The rule takes effect 1 July.
More from Regulation
More from Policy & Regulation
• By
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.
• By
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.
• By
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.