Subject: "Medical instruments and apparatus United States."

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Evaluation of field clinical laboratory equipment for fleet marine service
1994
Format: Electronic and Book

✔ Available

Call Number: Multiple Online Resources Available

FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment
2004
Format: Electronic and Book

✔ Available

Call Number: Access Content Online

FDA/ORA international inspection manual and travel guide
1997
Format: Book and Print

✔ Available Joyner - Fed Docs Stacks

Call Number: HE 20.4008:IN 7/2

The medical device excise tax : economic analysis
by Gravelle, Jane
2018
Format: Electronic and Book

✔ Available

Call Number: Access Content Online

Guidance for industry and FDA staff : expedited review of premarket submissions for devices
2008
Format: Electronic and Book

✔ Available

Call Number: Access Content Online

Guidance for industry and FDA staff : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements
2008
Format: Electronic and Book

✔ Available

Call Number: Access Content Online

Guidance for industry : cell selection devices for point of care production of minimally manipulated autologous peripheral blood stem cells (PBSCs).
2007
Format: Electronic and Book

✔ Available

Call Number: Access Content Online

Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products
2008
Format: Electronic and Book

✔ Available

Call Number: Access Content Online

Guidance for industry : drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals
2002
Format: Electronic and Book

✔ Available

Call Number: Access Content Online

Guidance for industry : "help-seeking" and other disease awareness communications by or on behalf of drug and device firms
2004
Format: Electronic and Book

✔ Available

Call Number: Access Content Online

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Evaluation of field clinical laboratory equipment for fleet marine service

FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment

FDA/ORA international inspection manual and travel guide

The medical device excise tax : economic analysis

Guidance for industry and FDA staff : expedited review of premarket submissions for devices

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 : cell selection devices for point of care production of minimally manipulated autologous peripheral blood stem cells (PBSCs).

Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products

Guidance for industry : drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals

Guidance for industry : "help-seeking" and other disease awareness communications by or on behalf of drug and device firms

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