Welcome to the Kids' Library!

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 approval applications (PMAs), effect on FDA review clock and g

[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

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

In vitro diagnostic (IVD) device studies, frequently asked questions

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, [2010] 2010

Modifications to devices subject to premarket approval (PMA) the PMA supplement decision-making proc

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

Premarket approval application filing review

[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, [2003] 2003

Premarket approval application modular review

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, [2003] 2003

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

Real-time premarket approval application (PMA) supplements

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, [2006] 2006

Use of symbols on labels and in labeling of in vitro diagnostic devices intended for professional us

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

User fees and refunds for premarket approval applications

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, [2003] 2003

User fees and refunds for premarket notification submissions (510(k)s)

[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