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1. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 6, 2017
Subject(s):
Equipment and Supplies -- standards
Equipment Design -- standards
Equipment Safety -- standards
Device Approval
Equipment Failure
Information Dissemination
Risk Management
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2017
Subject(s):
Device Approval
Papillomavirus Infections -- diagnosis
Reagent Kits, Diagnostic -- standards
Cervix Uteri -- cytology
Cervix Uteri -- virology
Equipment Failure
Equipment Safety
Genotyping Techniques -- standards
Mass Screening
Papillomaviridae -- classification
Papillomaviridae -- genetics
Quality Control
Reference Standards
Reproducibility of Results
Research Design
Specimen Handling
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Use of International Standard ISO 10993-1: "Biological evaluation of medical devices - part 1 : evaluation and testing within a risk management process" : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 4, 2020
Subject(s):
Device Approval
Equipment Failure
Equipment Safety
Equipment and Supplies -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. Compliance policy for limited modifications to certain marketed tobacco products

Publication:
Silver Spring, MD : Center for Tobacco Products, November 2019
Subject(s):
Electronic Nicotine Delivery Systems -- standards
Nicotine -- adverse effects
Tobacco Products -- adverse effects
Child
Consumer Product Safety
Equipment Failure
Product Packaging
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.