Research Catalog

Title

Modifications to devices subject to premarket approval (PMA) : the PMA supplement decision-making process.

Publication

[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]

Details

Additional Authors

• Center for Devices and Radiological Health (U.S.)
• Center for Biologics Evaluation and Research (U.S.)

Description

25 pages : digital, PDF file

Alternative Title

Guidance for industry and FDA staff

Subject

• Medical instruments and apparatus > Testing

Note

• Title from PDF title page (viewed on Mar. 24, 2009).
• "December 11, 2008."

System Details (note)

• Mode of access: Internet at the FDA Web site. Address as of 3/24/09: http://www.fda.gov/cdrh/ode/guidance/1584.pdf ; current access is available via PURL.

Call Number

GPO Internet HE 20.4802:D 49

OCLC

marcive316861304

Title

Modifications to devices subject to premarket approval (PMA) : the PMA supplement decision-making process.

Publisher

[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]

Type of Content

text

Type of Medium

computer

Type of Carrier

online resource

System Details

Mode of access: Internet at the FDA Web site. Address as of 3/24/09: http://www.fda.gov/cdrh/ode/guidance/1584.pdf ; current access is available via PURL.

Connect to:

https://purl.fdlp.gov/GPO/LPS110580

Added Author

Center for Devices and Radiological Health (U.S.)

Center for Biologics Evaluation and Research (U.S.)

Gpo Item No.

0499-T-02 (online)

Sudoc No.

HE 20.4802:D 49