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Guidance for industry and FDA staff interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements
Guidance for industry and FDA staff early development considerations for innovative combination products
Guidance for industry and FDA staff class II special controls guidance document : automated blood cell separator device operating by centrifugal or filtration separation principle
Guidance for industry and FDA staff commercially distributed analyte specific reagents (ASRs), frequently asked questions
Guidance for industry and FDA staff application user fees for combination products
Guidance for industry and FDA staff expedited review of premarket submissions for devices
Guidance for industry and FDA staff submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product
Guidance for industry and FDA staff devices used to process human cells, tissues, and cellular and tissue-based products (HCT/Ps)
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Guidance for industry and FDA staff
ID:
3451983
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