Free FDA-3429 - Federal

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE --- FOOD AND DRUG ADMINISTRATION

GENERAL DEVICE CLASSIFICATION QUESTIONNAIRE
PANEL MEMBER / PETITIONER

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

GENERIC TYPE OF DEVICE

CLASSIFICATION RECOMMENDATION

1. IS THE DEVICE LIFE-SUSTAINING OR LIFE-SUPPORTING ? 2. IS THE DEVICE FOR A USE WHICH IS OF SUBSTANTIAL IMPORTANCE IN PREVENTING IMPAIRMENT OF HUMAN HEALTH ? 3. DOES THE DEVICE PRESENT A POTENTIAL UNREASONABLE RISK OF ILLNESS OR INJURY ? 4. DID YOU ANSWER "YES" TO ANY OF THE ABOVE 3 QUESTIONS ?

YES YES YES YES

NO NO NO NO

Go to Item 2. Go to Item 3. Go to Item 4. If "Yes," go to Item 6. If "No," go to Item 5.

5. IS THERE SUFFICIENT INFORMATION TO DETERMINE THAT GENERAL CONTROLS ARE SUFFICIENT TO PROVIDE REASONABLE ASSURANCE OF SAFETY AND EFFECTIVENESS ? 6. IS THERE SUFFICIENT INFORMATION TO ESTABLISH SPECIAL CONTROLS IN ADDITION TO GENERAL CONTROLS TO PROVIDE REASONABLE ASSURANCE OF SAFETY AND EFFECTIVENESS ? 7. IF THERE IS SUFFICIENT INFORMATION TO ESTABLISH SPECIAL CONTROLS TO PROVIDE REASONABLE ASSURANCE OF SAFETY AND EFFECTIVENESS IDENTIFY BELOW THE SPECIAL CONTROL(S) NEEDED TO PROVIDE SUCH REASONABLE ASSURANCE. FOR CLASS II. Guidance Document Performance Standard(s) Device Tracking Testing Guidelines Other (Specify)

YES

NO

If "Yes," Classify in Class I. If "No," go to Item 6.

YES

NO

If "Yes," Classify in Class II and go to Item 7. If "No," Classify in Class III.

8. IF A REGULATORY PERFORMANCE STANDARD IS NEEDED TO PROVIDE REASONABLE ASSURANCE OF THE SAFETY AND EFFECTIVENESS OF A CLASS II OR III DEVICE, IDENTIFY THE PRIORITY FOR ESTABLISHING SUCH A STANDARD. Low Priority Medium Priority High Priority Not Applicable 9. FOR A DEVICE RECOMMENDED FOR RECLASSIFICATION INTO CLASS II, SHOULD THE RECOMMENDED REGULATORY PERFORMANCE STANDARD BE IN PLACE BEFORE THE RECLASSIFICATION TAKES EFFECT ?
10. FOR A DEVICE RECOMMENDED FOR CLASSIFICATION / RECLASSIFICATION INTO CLASS III, IDENTIFY THE PRIORITY FOR REQUIRING PREMARKET APPROVAL APPLICATION (PMA) SUBMISSIONS. Low Priority Medium Priority High Priority Not Applicable

YES

NO

NOT Applicable

FORM FDA 3429 (1/09)

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PSC Graphics (301) 443-1090

EF

11. IDENTIFY THE NEEDED RESTRICTION(S) Only upon the written or oral authorization of a practitioner licensed by law to administer or use the device Use only by persons with specific training or experience in its use Use only in certain facilities Other (Specify)

12. 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 3429 (1/09)

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INSTRUCTIONS FOR GENERAL DEVICE QUESTIONNAIRE
1. Answer each question by checking yes or no in the middle column and follow the instructions in the column on the right. The preparer should refer to Title 21 Part 860 of the Code of Federal Regulations for classification/reclassification definitions and procedures. The General Device questionnaire is designed to aid in the determination of the proper class for all medical devices. A medical device should be placed in the lowest class which will provide adequate controls to reasonably assure the safety and effectiveness of the device. Questions 1, 2, and 3 pertain to the degree of risk of the device and can be answered broadly. Questions 8 & 9 are not applicable unless a regulatory standard, subject to section 514 of the Food, Drug, and Cosmetic Act, as amended, 1976, has been designated as a "special control." Question 10 is applicable only to devices recommended for class III. Question 11 refers to restriction such as prescription use or similar limitations as to the use of the device. Use this completed questionnaire to prepare the Supplemental Data Sheet. Send both forms to the address indicated in question 12.

2. 3. 4. 5. 6. 7. 8.

FORM FDA 3429 (1/09)

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