pursuing evaluate device marketing use and approval. minimize risks; 4. Monitoring plan; 5. Summary of S&E data 6. Instructions for use and device labeling; 7. Commitment to patient protection; 8. Investigator agreement; and 9. Price, if will be sold. Continued "Continued 1. Public After Same rate of Yes IDE supplement 1. IRB approval Access Access to health completion enrollment as with: and Investigational need; or of clinical study 1. Justification for 2. Informed Devices 2. Preliminary trial extended study; consent. During PMA evidence that 2. Summary of S & Preparation device will be E and Review" effective and data and risks no significant posed by ODE Blue safety the device; Book IDE concerns. 3. Proposed Memorandum enrollment #D96-1 rate; 4. Clinical protocol; and 5. Progress towards marketing approval. of practice, FDA has expanded the criteria of "life-threatening condition" to include serious conditions such as sight-threatening and ‡As a matter limb-threatening conditions as well as other situations involving risk of irreversible morbidity. For questions or further information regarding the above table, contact the FDA IDE Staff at (301) 594-1190. Downloaded from the FDA website 5/20/2013:
pursuing marketing approval. evaluate device use and minimize risks; 4. Monitoring plan; 5. Summary of S&E data 6. Instructions for use and device labeling; 7. Commitment to patient protection; 8. Investigator agreement; and 9. Price, if will be sold. Continued Access "Continued Access to Investigational Devices During PMA Preparation and Review" ODE Blue Book IDE Memorandum #D96-1 1. Public health need; or 2. Preliminary evidence that device will be effective and no significant safety concerns. After completion of clinical trial Same rate of enrollment as study Yes IDE supplement with: 1. Justification for extended study; 2. Summary of S & E data and risks posed by the device; 3. Proposed enrollment rate; 4. Clinical protocol; and 5. Progress towards marketing approval. 1. IRB approval and 2. Informed consent. ‡As a matter of practice, FDA has expanded the criteria of "life-threatening condition" to include serious conditions such as sight-threatening and limb-threatening conditions as well as other situations involving risk of irreversible morbidity. For questions or further information regarding the above table, contact the FDA IDE Staff at (301) 594-1190. Downloaded from the FDA website 5/20/2013:
fda-chart-on-differences-between-single-timecompasionatetreatment-ideand-continued-access.docx