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1. Intent to exempt certain unclassified medical devices from premarket notification requirements: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, June 14, 2019

Subject(s):

Device Approval
Equipment and Supplies -- classification
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. Evaluation of devices used with regenerative medicine advanced therapies

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, February 2019

Subject(s):

Device Approval
Equipment and Supplies -- classification
Regenerative Medicine -- classification
Regenerative Medicine -- instrumentation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3. Factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019

Subject(s):

Cost-Benefit Analysis
Device Approval
Equipment and Supplies -- classification
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff

Publication:

Silver Spring, MD : Office of Combination Products, Food and Drug Administration, September 2017

Subject(s):

Biological Products -- classification
Classification -- methods
Equipment and Supplies -- classification
Pharmaceutical Preparations -- classification
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

7. Unique device identification: policy regarding compliance dates for class I and unclassified devices : immediately in effect guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, January 16, 2018

Subject(s):

Equipment and Supplies -- classification
Product Labeling -- standards
Product Packaging -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

8. How to prepare a pre-request for designation (pre-RFD)

Publication:

[Silver Spring, Maryland] : Office of Combination Products, Office of the Commissioner, February 2018

Subject(s):

Equipment and Supplies -- classification
Drugs, Investigational -- classification
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration