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Start Over Subjects Humans ✖Remove constraint Subjects: Humans Genre Technical Report ✖Remove constraint Genre: Technical Report Genre Guideline ✖Remove constraint Genre: Guideline Dates by Range 2000 and later ✖Remove constraint Dates by Range: 2000 and later

81. Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, Maryland] : Center for Devices and Radiological Health, September 29, 2017
Subject(s):
Device Approval -- standards
Clinical Protocols
Research Design
Telecommunications
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

82. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
Subject(s):
Clinical Laboratory Techniques
Device Approval -- standards
Diagnostic Test Approval -- standards
In Vitro Techniques -- standards
Reagent Kits, Diagnostic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

83. Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
Subject(s):
Data Display -- standards
Image Processing, Computer-Assisted -- standards
Radiology Information Systems -- standards
Device Approval -- standards
Product Labeling -- standards
Software -- standards
Technology, Radiologic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

84. M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2017
Subject(s):
Documentation -- standards
Drug Approval
Congresses as Topic
European Union
International Cooperation
Pharmaceutical Preparations -- standards
Humans
Canada
Europe
Japan
Switzerland
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

86. Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, October 25, 2017
Subject(s):
Device Approval -- standards
Equipment Design -- standards
Equipment Safety -- standards
Product Labeling -- standards
Reagent Kits, Diagnostic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

87. Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, October 25, 2017
Subject(s):
Device Approval -- standards
Software -- standards
Computer Security
Equipment Design -- standards
Equipment Safety -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

88. De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, October 30, 2017
Subject(s):
Classification
Device Approval -- standards
Equipment and Supplies -- classification
Equipment Safety -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

89. Product labeling for certain ultrasonic surgical aspirator devices: guidance for Industry and Food and Drug Administration staff

Publication:
[Silver Spring, Maryland] : Center for Devices and Radiological Health, October 30, 2017
Subject(s):
Product Labeling -- standards
Ultrasonic Surgical Procedures -- instrumentation
Ultrasonic Surgical Procedures -- standards
Equipment Safety -- standards
Leiomyoma -- surgery
Suction -- instrumentation
Suction -- standards
Surgical Equipment -- adverse effects
Ultrasonic Surgical Procedures -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

90. Manufacturers sharing patient-specific information from medical devices with patients upon request: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, Maryland] : Center for Devices and Radiological Health, October 30, 2017
Subject(s):
Access to Information
Equipment and Supplies -- standards
Health Records, Personal
Information Dissemination
Patient-Centered Care
Health Policy
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

93. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Antiviral Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Hepatitis C, Chronic -- drug therapy
Antiviral Agents -- pharmacokinetics
Drugs, Investigational -- pharmacokinetics
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

94. Recurrent herpes labialis: developing drugs for treatment and prevention

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Antiviral Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
Drugs, Investigational -- therapeutic use
Herpes Labialis -- drug therapy
Herpes Labialis -- prevention & control
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

95. Evaluating drug effects on the ability to operate a motor vehicle

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Automobile Driving
Driving Under the Influence
Drug Evaluation -- standards
Psychotropic Drugs -- adverse effects
Evaluation Studies as Topic
Reaction Time -- drug effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

96. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, December 2017
Subject(s):
Autografts -- standards
Biological Products -- standards
Biological Products -- therapeutic use
Tissue Transplantation -- standards
Transplantation, Autologous
Transplantation, Homologous
Transplants -- standards
Prostheses and Implants -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

97. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, November 2017
Subject(s):
Autografts -- standards
Biological Products -- standards
Biological Products -- therapeutic use
Tissue Transplantation
Transplantation, Autologous
Transplantation, Homologous
Transplants -- standards
Prostheses and Implants -- standards
Surgical Procedures, Operative
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

98. Unique device identification: direct marking of devices : guidance for Industry and Food and Drug administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, November 17, 2017
Subject(s):
Equipment and Supplies -- standards
Equipment Reuse -- standards
Product Labeling -- standards
Device Approval -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

99. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Abuse-Deterrent Formulations -- standards
Analgesics, Opioid -- administration & dosage
Drugs, Generic
Investigational New Drug Application
Administration, Oral
Administration, Inhalation
Clinical Trials as Topic
Drug Evaluation, Preclinical
Injections
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

100. Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, November 28, 2017
Subject(s):
Equipment Safety -- standards
Product Labeling -- standards
Radiation Dosage
Radiation Exposure -- adverse effects
Radiation Exposure -- standards
Radiography -- adverse effects
Radiography -- instrumentation
Adolescent
Child
Child, Preschool
Contraindications
Fluoroscopy -- adverse effects
Fluoroscopy -- instrumentation
Infant
Infant, Newborn
Radiation, Ionizing
Tomography Scanners, X-Ray Computed -- standards
Tomography, X-Ray Computed -- adverse effects
Young Adult
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.