Guidance
In September, the US FDA asked the public to weigh in on how AI-enabled medical devices perform in real-world settings. With the comment period now closed, the agency has heard back from dozens of stakeholders on how the agency can use clinical outcomes to better understand these devices.
The UK Medicines and Healthcare products Regulatory Agency said its RegulatoryConnect program “no longer offers value for money for UK taxpayers” and will be closed just 19 months after its April 2024 launch.
The US FDA is updating its menstrual products guidance for the first time since 2005, adding new recommendations for menstrual cups as well as additional testing guidelines. The document also reflects a new awareness of the potential risks of contaminants within menstrual products.
The US FDA has issued a draft guidance document to help device manufacturers navigate the new Quality Management System Regulation (QMSR) concerning premarket approval applications and humanitarian device exemptions applications. The new regs take effect in February.
FDA advisers gave a cautious nod to the idea of using generative AI in mental healthcare during a Nov. 6 panel meeting, saying evidence-backed tools could help expand access – but warning that safety, oversight, and the irreplaceable human connection remain major unanswered questions.
Stay current on regulatory guidelines from around the world with Medtech Insight’s Guidance Tracker. Over 60 documents have been posted on the tracker since its last update.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
The US FDA issued two safety alerts concerning associated risks from unauthorized medical devices. The alerts are consistent with a larger effort to clamp down on consumer goods that have not been subject to agency review.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 60 documents have been posted on the tracker since its last update.
The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
A panel of regulatory pros offered stakeholders tips for avoiding FDA citations after facility inspections. The July 29 webinar, hosted by ProPharma and Hyman Phelps and McNamara, follows the agency’s May announcement that it plans to up random foreign inspections.
The US FDA has updated its guidance document on small business eligibility determinations for medical device firms. Industry observers urge companies to ask for the status early to avoid any potential hold-ups.
NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.
The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.