Form FDA 3429 FDA 3429 General Device Classification Questionnaire

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

FORM APPROVED: OMB NO. 0910-0138
EXPIRATION DATE: January 31, 2006
(See OMB Statement on Page 2)

GENERAL DEVICE CLASSIFICATION QUESTIONNAIRE
PANEL MEMBER / PETITIONER

GENERIC TYPE OF DEVICE

DATE

CLASSIFICATION RECOMMENDATION

1. IS THE DEVICE LIFE-SUSTAINING OR LIFE-SUPPORTING ?

YES

NO

Go to Item 2.

2. IS THE DEVICE FOR A USE WHICH IS OF SUBSTANTIAL IMPORTANCE IN
PREVENTING IMPAIRMENT OF HUMAN HEALTH ?

YES

NO

Go to Item 3.

3. DOES THE DEVICE PRESENT A POTENTIAL UNREASONABLE RISK OF ILLNESS
OR INJURY ?

YES

NO

Go to Item 4.

YES

NO

If "Yes," go to Item 6.

4. DID YOU ANSWER "YES" TO ANY OF THE ABOVE 3 QUESTIONS ?

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 ?

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.

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)

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 ?

YES

NO

NOT Applicable
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

FORM FDA 3429 (1/03)

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PSC Media Arts (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
2098 Gaither Road, (HFZ-20)
Rockville, MD 20850

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 (1/03)

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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.

2.

The General Device questionnaire is designed to aid in the determination of the proper
class for all medical devices.

3.

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.

4.

Questions 1, 2, and 3 pertain to the degree of risk of the device and can be answered
broadly.

5.

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."

6.

Question 10 is applicable only to devices recommended for class III.

7.

Question 11 refers to restriction such as prescription use or similar limitations as to the use of
the device.

8.

Use this completed questionnaire to prepare the Supplemental Data Sheet. Send both
forms to the address indicated in question 12.

FORM FDA 3429 (1/03)

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