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Where can I obtain additional information regarding PMA and labeling?

• Alternative to Certain Prescription Device Labeling Requirements
  http://www.fda.gov/cdrh/comp/rxlabeling.html
  http://www.fda.gov/cdrh/comp/rxlabeling.pdf

• Device Advice - Labeling Requirements
  http://www.fda.gov/cdrh/devadvice/33.html

• Device Labeling Guidance #G91-1 (blue book memo)
  http://www.fda.gov/cdrh/g91-1.html

• Draft Report on Medical Device Labeling: Patients` and Lay Caregivers` Medical Device Information and Labeling Needs - Results of Qualitative Research
  http://www.fda.gov/cdrh/humfac/humfaclabel.pdf

• Electronic Labeling: Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) (New section 502(f) of the Federal Food, Drug, and Cosmetic Act) Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities - #G03-1
  http://www.fda.gov/cdrh/mdufma/bluebook/g03-1.html
  http://www.fda.gov/cdrh/mdufma/bluebook/g03-1.pdf

• Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers
  http://www.fda.gov/cdrh/ohip/guidance/1128.html
  http://www.fda.gov/cdrh/ohip/guidance/1128.pdf

• Human Factors Principles for Medical Device Labeling
  http://www.fda.gov/cdrh/dsma/227.html

• Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203)
  http://www.fda.gov/cdrh/dsma/470.pdf

• RX Labeling: Alternative to Certain Prescription Device Labeling Requirements
  http://www.fda.gov/cdrh/comp/rxlabeling.html
  http://www.fda.gov/cdrh/comp/rxlabeling.pdf

• Write it Right http://www.fda.gov/cdrh/dsma/897.pdf