In an exclusive interview with Medtech Insight, FDA device center director Jeff Shuren wouldn’t commit to meeting the agency’s internal deadline of April for putting out a draft version of its revised Quality System Regulation, which will be harmonized with international standard ISO 13485. Instead, he would only say that the rule would likely be out “sometime” in 2020. Shuren added that the FDA wants to “hit the ground running” when the new QSR is eventually finalized.
It looks increasingly unlikely that the US Food and Drug Administration will meet its own April deadline for releasing a draft version of its updated Quality System Regulation.
The FDA has been working on harmonizing its QSR with international quality systems standard ISO 13485 since mid-2018. A draft...
Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
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.
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
Increased support for NHS services and delivery infrastructure announced in the 11 June government spending review by chancellor of the exchequer Rachel Reeves could boost inward investment and offer new market opportunities for medtechs.
Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
