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Titles
- Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff1
- Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff1
- De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff1
- Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff1
- Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff1
- Developing and responding to deficiencies in accordance with the least burdensome provisions: guidance for industry and Food and Drug Administration staff1
- Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff1
- FDA medical device reviews: evaluation is needed to assure requests for additional information follow a least burdensome approach : report to Congressional requestors1
- 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 staff1
- Unique device identification: direct marking of devices : guidance for Industry and Food and Drug administration staff1