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1391. 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.

1392. 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.

1393. 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.

1394. 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.

1395. Formal dispute resolution: sponsor appeals above the division level : guidance for industry and review staff : good review practice

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Dissent and Disputes
Investigational New Drug Application
Negotiating
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

1397. 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.

1398. 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.

1399. 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.

1400. 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.