The Resource 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 : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements

Label
Guidance for industry and FDA staff : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements
Title
Guidance for industry and FDA staff
Title remainder
interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements
Title variation
Interactive review for medical device submissions
Contributor
Subject
Genre
Language
eng
Cataloging source
GPO
Government publication
federal national government publication
Index
no index present
Literary form
non fiction
Nature of contents
dictionaries
http://library.link/vocab/relatedWorkOrContributorName
  • Center for Devices and Radiological Health (U.S.)
  • Center for Biologics Evaluation and Research (U.S.)
http://library.link/vocab/subjectName
  • Medical instruments and apparatus
  • User charges
Label
Guidance for industry and FDA staff : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements
Instantiates
Publication
Note
  • Title from PDF title page (viewed on April 27, 2008)
  • "February 28, 2008"
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Color
one color
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Control code
319438117
Extent
11 pages
Form of item
online
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Other physical details
digital, PDF file
Specific material designation
remote
System details
Mode of access: Internet at the FDA CBER Web site. Address as of 4/27/09: http://www.fda.gov/cdrh/ode/guidance/1655.pdf ; current access is available via PURL
Label
Guidance for industry and FDA staff : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements
Publication
Note
  • Title from PDF title page (viewed on April 27, 2008)
  • "February 28, 2008"
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Color
one color
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Control code
319438117
Extent
11 pages
Form of item
online
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Other physical details
digital, PDF file
Specific material designation
remote
System details
Mode of access: Internet at the FDA CBER Web site. Address as of 4/27/09: http://www.fda.gov/cdrh/ode/guidance/1655.pdf ; current access is available via PURL

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