+-------+-----------------------+------------+---+------------------+---+
| DEPAR |                       |            |   | FORM APPROVED:   |   |
| TMENT |                       |            |   | OMB NO.          |   |
| OF    |                       |            |   | 0910-0138        |   |
| H     |                       |            |   |                  |   |
| EALTH |                       |            |   | EXPIRATION DATE: |   |
| AND   |                       |            |   | January 31, 2003 |   |
| HUMAN |                       |            |   |                  |   |
| SER   |                       |            |   | (See OMB         |   |
| VICES |                       |            |   | Statement on     |   |
|       |                       |            |   | Page 2)          |   |
| FOOD  |                       |            |   |                  |   |
| AND   |                       |            |   |                  |   |
| DRUG  |                       |            |   |                  |   |
| ADMI  |                       |            |   |                  |   |
| NISTR |                       |            |   |                  |   |
| ATION |                       |            |   |                  |   |
|       |                       |            |   |                  |   |
| **SU  |                       |            |   |                  |   |
| PPLEM |                       |            |   |                  |   |
| ENTAL |                       |            |   |                  |   |
| DATA  |                       |            |   |                  |   |
| SH    |                       |            |   |                  |   |
| EET** |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| ###   |                       |            |   |                  |   |
| ####  |                       |            |   |                  |   |
| Panel |                       |            |   |                  |   |
|  Reco |                       |            |   |                  |   |
| mmend |                       |            |   |                  |   |
| ation |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| 1\.   |                       |            |   |                  |   |
| GE    |                       |            |   |                  |   |
| NERIC |                       |            |   |                  |   |
| TYPE  |                       |            |   |                  |   |
| OF    |                       |            |   |                  |   |
| D     |                       |            |   |                  |   |
| EVICE |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| >     |                       |            |   |                  |   |
|       |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| 2\.   |                       |            |   | 3\. IS DEVICE AN |   |
| ADV   |                       |            |   | IMPLANT (21 CFR  |   |
| ISORY |                       |            |   | 860.3)?          |   |
| PANEL |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| >     |                       |            |   | Yes No           |   |
|       |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| 4\.   |                       |            |   |                  |   |
| I     |                       |            |   |                  |   |
| NDICA |                       |            |   |                  |   |
| TIONS |                       |            |   |                  |   |
| FOR   |                       |            |   |                  |   |
| USE   |                       |            |   |                  |   |
| IN    |                       |            |   |                  |   |
| THE   |                       |            |   |                  |   |
| DEV   |                       |            |   |                  |   |
| ICE'S |                       |            |   |                  |   |
| LAB   |                       |            |   |                  |   |
| ELING |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| >     |                       |            |   |                  |   |
|       |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| 5\.   |                       |            |   |                  |   |
| IDEN  |                       |            |   |                  |   |
| TIFIC |                       |            |   |                  |   |
| ATION |                       |            |   |                  |   |
| OF    |                       |            |   |                  |   |
| ANY   |                       |            |   |                  |   |
| RISKS |                       |            |   |                  |   |
| TO    |                       |            |   |                  |   |
| H     |                       |            |   |                  |   |
| EALTH |                       |            |   |                  |   |
| PRES  |                       |            |   |                  |   |
| ENTED |                       |            |   |                  |   |
| BY    |                       |            |   |                  |   |
| D     |                       |            |   |                  |   |
| EVICE |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| > Ge  |                       |            |   |                  |   |
| neral |                       |            |   |                  |   |
| >     |                       |            |   |                  |   |
|       |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| 6\.   |                       |            |   |                  |   |
| R     |                       |            |   |                  |   |
| ECOMM |                       |            |   |                  |   |
| ENDED |                       |            |   |                  |   |
| ADV   |                       |            |   |                  |   |
| ISORY |                       |            |   |                  |   |
| PANEL |                       |            |   |                  |   |
| CLAS  |                       |            |   |                  |   |
| SIFIC |                       |            |   |                  |   |
| ATION |                       |            |   |                  |   |
| A     |                       |            |   |                  |   |
| NDPRI |                       |            |   |                  |   |
| ORITY |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| >     |                       | > Priority |   |                  |   |
|  Clas |                       | > (Class   |   |                  |   |
| sific |                       | > II or    |   |                  |   |
| ation |                       | > III      |   |                  |   |
|       |                       | > Only)    |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
|       |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| 7\.   |                       |            |   |                  |   |
| IF    |                       |            |   |                  |   |
| D     |                       |            |   |                  |   |
| EVICE |                       |            |   |                  |   |
| IS AN |                       |            |   |                  |   |
| IMP   |                       |            |   |                  |   |
| LANT, |                       |            |   |                  |   |
| OR IS |                       |            |   |                  |   |
| LIFE- |                       |            |   |                  |   |
| SUSTA |                       |            |   |                  |   |
| INING |                       |            |   |                  |   |
| OR    |                       |            |   |                  |   |
| LIFE- |                       |            |   |                  |   |
| SUPPO |                       |            |   |                  |   |
| RTING |                       |            |   |                  |   |
| AND   |                       |            |   |                  |   |
| HAS   |                       |            |   |                  |   |
| BEEN  |                       |            |   |                  |   |
| CLASS |                       |            |   |                  |   |
| IFIED |                       |            |   |                  |   |
| INA   |                       |            |   |                  |   |
| CAT   |                       |            |   |                  |   |
| EGORY |                       |            |   |                  |   |
| OTHER |                       |            |   |                  |   |
| THAN  |                       |            |   |                  |   |
| CLASS |                       |            |   |                  |   |
| III,  |                       |            |   |                  |   |
| EX    |                       |            |   |                  |   |
| PLAIN |                       |            |   |                  |   |
|       |                       |            |   |                  |   |
| F     |                       |            |   |                  |   |
| ULLY, |                       |            |   |                  |   |
| THE   |                       |            |   |                  |   |
| RE    |                       |            |   |                  |   |
| ASONS |                       |            |   |                  |   |
| FOR   |                       |            |   |                  |   |
| THE   |                       |            |   |                  |   |
| LOWER |                       |            |   |                  |   |
| CLAS  |                       |            |   |                  |   |
| SIFIC |                       |            |   |                  |   |
| ATION |                       |            |   |                  |   |
| WITH  |                       |            |   |                  |   |
| SUPPO |                       |            |   |                  |   |
| RTING |                       |            |   |                  |   |
| DOC   |                       |            |   |                  |   |
| UMENT |                       |            |   |                  |   |
| ATION |                       |            |   |                  |   |
| AND   |                       |            |   |                  |   |
| DATA  |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| >     |                       |            |   |                  |   |
|       |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| 8\.   |                       |            |   |                  |   |
| SU    |                       |            |   |                  |   |
| MMARY |                       |            |   |                  |   |
| OF    |                       |            |   |                  |   |
| IN    |                       |            |   |                  |   |
| FORMA |                       |            |   |                  |   |
| TION, |                       |            |   |                  |   |
| INCL  |                       |            |   |                  |   |
| UDING |                       |            |   |                  |   |
| CLI   |                       |            |   |                  |   |
| NICAL |                       |            |   |                  |   |
| EXPER |                       |            |   |                  |   |
| IENCE |                       |            |   |                  |   |
| OR    |                       |            |   |                  |   |
| JUDG  |                       |            |   |                  |   |
| MENT, |                       |            |   |                  |   |
| UPON  |                       |            |   |                  |   |
| WHICH |                       |            |   |                  |   |
| CLAS  |                       |            |   |                  |   |
| SIFIC |                       |            |   |                  |   |
| ATION |                       |            |   |                  |   |
| RECO  |                       |            |   |                  |   |
| MMEND |                       |            |   |                  |   |
| ATION |                       |            |   |                  |   |
| IS    |                       |            |   |                  |   |
| BASED |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| >     |                       |            |   |                  |   |
|       |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| 9\.   |                       |            |   |                  |   |
| IDEN  |                       |            |   |                  |   |
| TIFIC |                       |            |   |                  |   |
| ATION |                       |            |   |                  |   |
| OF    |                       |            |   |                  |   |
| ANY   |                       |            |   |                  |   |
| N     |                       |            |   |                  |   |
| EEDED |                       |            |   |                  |   |
| RE    |                       |            |   |                  |   |
| STRIC |                       |            |   |                  |   |
| TIONS |                       |            |   |                  |   |
| ON    |                       |            |   |                  |   |
| THE   |                       |            |   |                  |   |
| USE   |                       |            |   |                  |   |
| OF    |                       |            |   |                  |   |
| THE   |                       |            |   |                  |   |
| D     |                       |            |   |                  |   |
| EVICE |                       |            |   |                  |   |
| *(    |                       |            |   |                  |   |
| e.g., |                       |            |   |                  |   |
| sp    |                       |            |   |                  |   |
| ecial |                       |            |   |                  |   |
| labe  |                       |            |   |                  |   |
| ling, |                       |            |   |                  |   |
| ban   |                       |            |   |                  |   |
| ning, |                       |            |   |                  |   |
| or    |                       |            |   |                  |   |
| pr    |                       |            |   |                  |   |
| escri |                       |            |   |                  |   |
| ption |                       |            |   |                  |   |
| use)* |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+
| >     |                       |            |   |                  |   |
|       |                       |            |   |                  |   |
+-------+-----------------------+------------+---+------------------+---+

+---+----------+---+---+---+---+--------------------------------------------------+---+
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+---+----------+---+---+---+---+--------------------------------------------------+---+
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+---+----------+---+---+---+---+--------------------------------------------------+---+
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| e |          |   |   |   |   |                                                  |   |
| n |          |   |   |   |   |                                                  |   |
| t |          |   |   |   |   |                                                  |   |
| l |          |   |   |   |   |                                                  |   |
| y |          |   |   |   |   |                                                  |   |
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| v |          |   |   |   |   |                                                  |   |
| a |          |   |   |   |   |                                                  |   |
| l |          |   |   |   |   |                                                  |   |
| i |          |   |   |   |   |                                                  |   |
| d |          |   |   |   |   |                                                  |   |
| > |          |   |   |   |   |                                                  |   |
|   |          |   |   |   |   |                                                  |   |
| O |          |   |   |   |   |                                                  |   |
| M |          |   |   |   |   |                                                  |   |
| B |          |   |   |   |   |                                                  |   |
| > |          |   |   |   |   |                                                  |   |
|   |          |   |   |   |   |                                                  |   |
| c |          |   |   |   |   |                                                  |   |
| o |          |   |   |   |   |                                                  |   |
| n |          |   |   |   |   |                                                  |   |
| t |          |   |   |   |   |                                                  |   |
| r |          |   |   |   |   |                                                  |   |
| o |          |   |   |   |   |                                                  |   |
| l |          |   |   |   |   |                                                  |   |
| > |          |   |   |   |   |                                                  |   |
|   |          |   |   |   |   |                                                  |   |
| n |          |   |   |   |   |                                                  |   |
| u |          |   |   |   |   |                                                  |   |
| m |          |   |   |   |   |                                                  |   |
| b |          |   |   |   |   |                                                  |   |
| e |          |   |   |   |   |                                                  |   |
| r |          |   |   |   |   |                                                  |   |
| . |          |   |   |   |   |                                                  |   |
| * |          |   |   |   |   |                                                  |   |
+---+----------+---+---+---+---+--------------------------------------------------+---+

+-----------------------------------------------------------------------+
| **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 form 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.                                                            |
+-----------------------------------------------------------------------+