New draft guidance from the US Food and Drug Administration would mandate that patients considering Laser-Assisted in Situ Keratomileusis (LASIK) get additional information about potential risks of the popular vision-correcting treatment.
Draft FDA Guidance Aims To Ensure Patients Understand LASIK Risks
The document would ask manufacturers to include additional plain-language labeling to ensure people considering LASIK have additional information about potential side effects and contraindications.

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International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.
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.
Medtech Insight sat down with Arcadia's chief strategy officer Aneesh Chopra to discuss interoperability, industry standards and the future of health care data and AI.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 30 documents have been posted on the tracker since its last update.
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