Information for Keratome Manufacturers Regarding LASIK - Final Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
June 20, 2001
March 19, 2020
e5b189cc-d972-4a93-8dc5-b39ad36a40e3
Related Documents
Guidance Document for Dura Substitute Devices - Guidance for Industry
Guidance DocumentNovember 8, 2000Center for Devices and Radiological Health
Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation - Guidance for Industry and FDA Reviewers
Guidance DocumentJanuary 15, 2001Center for Devices and Radiological Health
Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff
Guidance DocumentMay 28, 2001Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox