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Bundling multiple devices or multiple indications in a single submission

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2007] 2007

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2004] 2004

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2008] 2008

Guidance for industry and FDA staff interactive review for medical device submissions, 510(k)s, orig

[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2008] 2008

Guidance for industry cell selection devices for point of care production of minimally manipulated a

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2007] 2007

Guidance for industry preparation of IDEs and INDs for products intended to repair or replace knee c

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Devices and Radiological Health, [2007] 2007

Managing the risks from medical product use : creating a risk management framework : report to the F

United States. Food and Drug Administration. Task Force on Risk Management.
[Rockville, Md.?] : U.S. Dept. of Health and Human Services, Food and Drug Administration, [1999] 1999

Premarket assessment of pediatric medical devices

[Rockville, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2004] 2004