Free FDA-3427 - Federal

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

SUPPLEMENTAL DATA SHEET
Panel Recommendation
1. GENERIC TYPE OF DEVICE 2. ADVISORY PANEL 4. INDICATIONS FOR USE IN THE DEVICE'S LABELING

FORM APPROVED: OMB NO. 0910-0138 EXPIRATION DATE: March 31, 2009 (See OMB Statement on Page 2)

3. IS DEVICE AN IMPLANT (21 CFR 860.3)? Yes No

5. IDENTIFICATION OF ANY RISKS TO HEALTH PRESENTED BY DEVICE General

6. RECOMMENDED ADVISORY PANEL CLASSIFICATION AND PRIORITY Classification Priority (Class II or III Only)

7. IF DEVICE IS AN IMPLANT, OR IS LIFE-SUSTAINING OR LIFE-SUPPORTING AND HAS BEEN CLASSIFIED IN A CATEGORY OTHER THAN CLASS III, EXPLAIN FULLY, THE REASONS FOR THE LOWER CLASSIFICATION WITH SUPPORTING DOCUMENTATION AND DATA

8. SUMMARY OF INFORMATION, INCLUDING CLINICAL EXPERIENCE OR JUDGMENT, UPON WHICH CLASSIFICATION RECOMMENDATION IS BASED

9. IDENTIFICATION OF ANY NEEDED RESTRICTIONS ON THE USE OF THE DEVICE (e.g., special labeling, banning, or prescription use)

FORM FDA 3427 (1/09)

PSC Graphics (301) 443-1090

EF

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10. IF DEVICE IS RECOMMENDED FOR CLASS I, RECOMMEND WHETHER FDA SHOULD EXEMPT IT FROM

Justification / Comments
a. Registration / Device Listing b. Premarket Notification c. Records and Reports d. Good Manufacturing Practice 11. IF DEVICE IS RECOMMENDED FOR CLASS II, RECOMMEND WHETHER FDA SHOULD EXEMPT IT FROM PREMARKET NOTIFICATION a. Exempt b. Not Exempt Justifications/Comments

12. EXISTING STANDARDS APPLICABLE TO THE DEVICE, DEVICE SUBASSEMBLIES (Components) OR DEVICE MATERIALS (Parts and Accessories)

13. COMPLETE THIS FORM PURSUANT TO 21 CFR PART 860 AND SUBMIT TO:

Food and Drug Administration Center for Devices and Radiological Health Office of Health and Industry Programs (HFZ-215) 1350 Piccard Drive Rockville, MD 20850

OMB STATEMENT

Public reporting burden for this collection of information is estimated to average 1-2 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer (HFA-710) 5600 Fishers Lane Rockville, MD 20857

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

FORM FDA 3427 (1/09)

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INSTRUCTIONS FOR SUPPLEMENTAL DATA SHEET
1. The Supplemental Data Sheet should be prepared in conjunction with the General Device Questionnaire. The preparer should refer to Title 21 Part 860 of the Code of Federal Regulations for classification / reclassification definitions and procedures. 2. The Supplemental Data Sheet is designed to provide the device description, intended use, the risks of the device, the recommended class and the scientific support for the class and proposed level of controls. 3. The information requested by questions 1 through 8 must be provided for all devices. 4. Question 9 can be answered by referring to question 11 of the General Device Questionnaire. 5. Question 10 refers only to devices recommended for class I, and is a recommendation for exemptions from the General Controls listed. 6. Question 11 refers only to devices recommended for Class II. 7. Question 12 requests the listing of any existing standards for the device being classified. The standards to be listed could be standards drafted by professional groups, standards groups or manufacturers. 8. Send this completed form and the appropriate questionnaire to the address indicated in item 13.

FORM FDA 3427 (1/09)

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