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

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

Label
FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment
Title
FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment
Title variation
Guidance for industry and FDA staff
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
  • User charges
  • Medical instruments and apparatus
Label
FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment
Instantiates
Publication
Note
  • Title from PDF title page (viewed on May 22, 2009)
  • "Document issued on: May 21, 2004"
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
341605154
Extent
14 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 5/22/09: http://www.fda.gov/cdrh/mdufma/guidance/1219.pdf ; current access is available via PURL
Label
FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment
Publication
Note
  • Title from PDF title page (viewed on May 22, 2009)
  • "Document issued on: May 21, 2004"
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
341605154
Extent
14 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 5/22/09: http://www.fda.gov/cdrh/mdufma/guidance/1219.pdf ; current access is available via PURL

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