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8401. 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, December 16, 2019
Subject(s):
Device Approval -- standards
Equipment and Supplies -- standards
Manufactured Materials -- standards
Device Approval -- legislation & jurisprudence
Time Factors
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

8402. Unique device identification: convenience kits : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, April 26, 2019
Subject(s):
Equipment and Supplies -- standards
Product Labeling -- standards
Equipment Reuse
Product Packaging -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8403. Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 7, 2019
Subject(s):
Congresses as Topic -- standards
Device Approval -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8404. Utilizing animal studies to evaluate organ preservation devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):
Device Approval -- standards
Evaluation Studies as Topic
Organ Preservation -- instrumentation
Organ Preservation -- standards
Perfusion -- instrumentation
Reperfusion -- instrumentation
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8405. Medical x-ray imaging devices conformance: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):
Device Approval -- standards
Electrical Equipment and Supplies -- classification
Electrical Equipment and Supplies -- standards
Radiography -- classification
Radiography -- instrumentation
Equipment Safety
Guideline Adherence
Tomography Scanners, X-Ray Computed -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8406. Policy clarification for certain fluoroscopic equipment requirements: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):
Fluoroscopy -- standards
Radiation Exposure -- standards
Equipment Safety
Fluoroscopy -- instrumentation
Radiation Exposure -- prevention & control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8407. Laser products: conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 : (Laser Notice No. 56) : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):
Equipment Safety
Lasers -- classification
Lasers -- standards
Certification
Device Approval -- standards
Guideline Adherence
Product Labeling
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8408. Classification and requirements for laser illuminated projectors (LIPs): (Laser Notice No. 57) : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):
Equipment Safety
Lasers -- classification
Lasers -- standards
Device Approval
Lasers -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8409. Preparation of food contact notifications for food contact substances in contact with infant formula and/or human milk

Publication:
College Park, MD : Center for Food Safety and Applied Nutrition, May 2019
Subject(s):
Food Contamination -- prevention & control
Food Safety
Infant Formula -- standards
Milk, Human -- chemistry
Carcinogenicity Tests
Infant
Infant, Newborn
Toxicity Tests
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8410. Recommendations for reducing the risk of transfusion-transmitted babesiosis

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, May 2019
Subject(s):
Babesiosis -- transmission
Blood Transfusion
Disease Transmission, Infectious -- prevention & control
Donor Selection -- standards
Babesiosis -- prevention & control
Blood -- microbiology
Surveys and Questionnaires
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

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