The US FDA has updated its electronic Medical Device Reporting system to accept adverse event codes devised by the International Medical Device Regulators Forum. The agency is urging reporters using an AS2 submission account to “update their systems as soon as possible.”
In a long-planned update, the US Food and Drug Administration’s electronic Medical Device Reporting (eMDR) system now accepts adverse event codes devised by the International Medical Device Regulators Forum (IMDRF).
The change affects Secs. F10 and H6 of the FDA’s MedWatch 3500A adverse event reporting form, “Adverse Event Problem.” User...
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.
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?
Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.
