A newly finalized FDA guidance on device firm inspection procedures recommends a five-day advance warning, three- to six-day inspections and lots of verbal communication throughout the process.
The COVID-19 pandemic has hit a temporary pause button on routine inspections of device firms by the US Food and Drug Administration. But background work on inspections continues, and that includes a new final guidance document offering guidelines on how the agency will conduct device establishment inspections.
The document, which was published 25 June, finalizes a draft guidance issued in March 2019. The FDA Reauthorization Act (FDARA)...
A late-August batch of device classifications from the US FDA includes genetic tests from 23andMe, hand-held spinal surgery tools, and several IVDs.
Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.
The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.
An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.
The US FDA has cleared NeuroOne's OneRF trigeminal nerve ablation system for the treatment of trigeminal neuralgia. This minimally invasive method utilizes radio frequency energy to alleviate pain, offering an alternative to traditional medications and surgeries. A fall commercial launch is planned.
The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.
After receiving FDA clearance for its Genio sleep apnea implant, Nyxoah plans a major US rollout despite a patent suit from rival Inspire Medical. Genio offers bilateral nerve stimulation as a CPAP alternative, with strong trial results.
