Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
July 30, 2001
March 19, 2020
ca510d51-2927-4aef-9724-b0f778a2572a
Related Documents
Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems - Guidance for Industry and FDA Staff
Guidance DocumentSeptember 4, 2003Center for Devices and Radiological Health
Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff
Guidance DocumentFebruary 3, 2003Center for Devices and Radiological Health
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff
Guidance DocumentJuly 6, 2001Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.