FDA’s device center thought a planned proposed regulation for requiring 510(k) transfer-of-ownership updates would be a “pretty simple idea,” but it turned out to be more complicated than expected.
In developing a proposed regulation intended to improve how transfers of ownership of 510(k) clearances are updated in FDA’s systems, CDRH says it faces problems making the process both entirely electronic and least burdensome for companies.
As of now, the device center says it plans to link the 510(k) database with its registration and listing
The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?
