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1. Health care without the doctor: how new devices and technologies aid clinicians and consumers

Publication:
Oakland, Calif. : California HealthCare Foundation, c2009
Subject(s):
Decision Making, Computer-Assisted
Decision Support Techniques
Delivery of Health Care -- methods
Home Nursing
Internet
Patient Participation
Point-of-Care Systems
Reagent Kits, Diagnostic
Self Care
Allied Health Personnel
Ambulatory Care Facilities
Community Participation
Device Approval
Equipment Safety
Evidence-Based Medicine
Federal Government
Government Regulation
Health Care Sector
Health Policy
Insurance, Health, Reimbursement
Patient Advocacy
Privacy
State Government
Treatment Outcome
Humans
Diagnosis, Computer-Assisted
California

2. Logical observation identifiers names and codes for in vitro diagnostic tests: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, June 15, 2018
Subject(s):
Electronic Health Records
Health Information Interoperability
Logical Observation Identifiers Names and Codes
Reagent Kits, Diagnostic
Device Approval
In Vitro Techniques -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Policy for monkeypox tests to address the public health emergency: guidance for laboratories, commercial manufacturers, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, September 7, 2022
Subject(s):
Government Regulation
Monkeypox -- diagnosis
Monkeypox -- prevention & control
Public Health
Reagent Kits, Diagnostic
United States
United States. Food and Drug Administration

6. Recommendations for dual 510(k) and CLIA waiver by application studies: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020
Subject(s):
Clinical Laboratory Techniques
Device Approval
Reagent Kits, Diagnostic
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
Subject(s):
Compassionate Use Trials -- standards
Cost-Benefit Analysis
Device Approval -- standards
Equipment and Supplies -- classification
Uncertainty
Data Collection
Reagent Kits, Diagnostic
Research Design
Sample Size
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.