SENATE AMENDMENT

    Bill No. SB 1396

    Amendment No. 1

                            CHAMBER ACTION
              Senate                               House
                                   .
                                   .
 1                                 .
                                   .
 2                                 .
                                   .
 3                                 .
                                   .
 4                                                                

 5

 6

 7

 8

 9

10                                                                

11  The Committee on Health, Aging and Long-Term Care recommended

12  the following amendment:

13

14         Senate Amendment (with title amendment) 

15         On page 1, lines 19-27, delete those lines

16

17  and insert:

18         (8)  Notwithstanding any requirements set forth in ss.

19  499.001-499.081, a manufacturer of medical devices that is

20  registered with the federal Food and Drug Administration is

21  exempt from ss. 499.015 and 499.041(6) if:

22         (a)  The manufacturer's medical devices are approved

23  for marketing by, or listed with the federal Food and Drug

24  Administration in accordance with federal law for commercial

25  distribution; or

26         (b)  The manufacturer subcontracts with a manufacturer

27  of medical devices to manufacture components of such devices.

28

29  However, the manufacturer must submit evidence of such

30  registration, listing, or approval with its initial

31  application for a permit to do business in this state, as

                                  1
    1:51 PM   03/11/99                                 s1396.hc.01




                                                  SENATE AMENDMENT

    Bill No. SB 1396

    Amendment No. 1





 1  required in s. 499.013 and any changes to such information

 2  previously submitted at the time of renewal of the permit.

 3  Evidence of approval, listing, and registration by the federal

 4  Food and Drug Administration must include:

 5

 6

 7  ================ T I T L E   A M E N D M E N T ===============

 8  And the title is amended as follows:

 9         On page 1, lines 5-7, delete those lines

10

11  and insert:

12  F.S., manufacturers of medical devices that meet specified

13  requirements of the federal Food and Drug Administration;

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

                                  2
    1:51 PM   03/11/99                                 s1396.hc.01