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3402. Arthroscopy pump tubing sets intended for multiple patient use - Premarket Notification (510(k)) submissions: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, December 23, 2021
Subject(s):
Arthroscopy -- instrumentation
Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3403. Non-clinical and clinical investigation of devices used for the treatment of benign prostatic hyperplasia (BPH): guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, December 27, 2021
Subject(s):
Device Approval
Prostatic Hyperplasia -- therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3408. Pain points along the journey from skilled nursing facility to home: patient and caregiver perspectives

Author(s):
Kothari, Pooja, author
Mallon, Kevin, author
Rogut, Lynn, author
Guzik, Joan, author
Publication:
[New York, New York] : United Hospital Fund, October 2021
Subject(s):
Home Nursing
Patient Discharge
Patient Transfer
Skilled Nursing Facilities
Transitional Care
COVID-19
Patient Education as Topic
Surveys and Questionnaires
New York
United States

3409. CMC postapproval manufacturing changes for specified biological products to be documented in annual reports

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2021
Subject(s):
Annual Reports as Topic
Biological Products -- standards
Biological Products -- supply & distribution
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3410. Policy for coronavirus disease-2019 tests during the public health emergency (revised): guidance for developers and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, November 15, 2021
Subject(s):
COVID-19 Serological Testing -- standards
COVID-19 Testing -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration