Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-one documents have been posted on the tracker since its last update.
Forty-one guidance documents on medical devices and diagnostics issued by regulatory authorities from around the world were added to Medtech Insight’sGuidance Tracker in the past month.
The updated tracker includes an updated guideline endorsed by the EU Medical Device Coordination Group on classification rules for in...
Create an account to read this article
Already a subscriber?
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The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products.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.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.
The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
