General Device Classification Questionnaire FDA-3429 HHS/PSC

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Specifications	General Device Classification Questionnaire FDA-3429 HHS/PSC
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Other (Specify) FORM FDA 3429 (1/09) FORM APPROVED: OMB NO. 0910-0138 EXPIRATION DATE: March 31, 2009 (See OMB Statement on P

Specifications	General Device Classification Questionnaire FDA-3429 HHS/PSC
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Content	Other (Specify) FORM FDA 3429 (1/09) FORM APPROVED: OMB NO. 0910-0138 EXPIRATION DATE: March 31, 2009 (See OMB Statement on Page 2) DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE - FOOD AND DRUG ADMINISTRATION GENERAL DEVICE CLASSIFICATION QUESTIONNAIRE 1. IS THE DEVICE LIFE-SUSTAINING OR LIFE-SUPPORTING ? Go to Item 3. YESNO 6. IS THERE SUFFICIENT INFORMATION TO ESTABLISH SPECIAL CONTROLS IN ADDITION TO GENERAL CONTROLS TO PROVIDE REASONABLE ASSURANCE OF SAFETY AND EFFECTIVENESS ? YESNOIf 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 2. IS THE DEVICE FOR A USE WHICH IS OF SUBSTANTIAL IMPORTANCE IN PREVENTING IMPAIRMENT OF HUMAN HEALTH ? Guidance Document Performance Standard(s) Device Tracking Testing Guidelines 3. DOES THE DEVICE PRESENT A POTENTIAL UNREASONABLE RISK OF ILLNESS OR INJURY ? Go to Item 2. YESNO YES DATEPANEL MEMBER / PETITIONER GENERIC TYPE OF DEVICECLASSIFICATION RECOMMENDATION 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 NOIf Yes, Classify in Class I. If No, go to Item 6. NOT Applicable YESNOGo to Item 4. 4. DID YOU ANSWER YES TO ANY OF THE ABOVE 3 QUESTIONS ?YESNOIf Yes, go to Item 6. If No, go to Item 5. NOYES 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. Page 1 PSC Graphics (301) 443-1090 EF 5. IS THERE SUFFICIENT INFORMATION TO DETERMINE THAT GENERAL CONTROLS ARE SUFFICIENT TO PROVIDE REASONABLE ASSURANCE OF SAFETY AND EFFECTIVENESS ?
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