Senate Bill 1396

    Florida Senate - 1999                                  SB 1396

    By Senator Burt





    16-729-99

  1                      A bill to be entitled

  2         An act relating to the registration of drugs,

  3         devices, and cosmetics; amending s. 499.015,

  4         F.S.; exempting from ss. 499.015, 499.041(6),

  5         F.S., each manufacturer of medical devices that

  6         are approved by, registered with, and listed

  7         with the federal Food and Drug Administration;

  8         requiring certain information to be submitted

  9         with such a manufacturer's application for a

10         permit to do business in this state; providing

11         an effective date.

12

13  Be It Enacted by the Legislature of the State of Florida:

14

15         Section 1.  Subsection (8) is added to section 499.015,

16  Florida Statutes, 1998 Supplement, to read:

17         499.015  Registration of drugs, devices, and cosmetics;

18  issuance of certificates of free sale.--

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

20  499.001-499.081, a manufacturer of medical devices that are

21  approved by, registered with, and listed with the federal Food

22  and Drug Administration is exempt from ss. 499.015 and

23  499.041(6). However, the manufacturer must submit evidence of

24  such registration, listing, and approval with its application

25  for a permit to do business in this state, as required in s.

26  499.013. Evidence of approval and registration by the federal

27  Food and Drug Administration must include:

28         (a)  For Class II devices, a copy of the pre-market

29  notification letter (510K);

30         (b)  For Class III devices, a Federal Drug

31  Administration pre-market approval number;

                                  1

CODING: Words stricken are deletions; words underlined are additions.






    Florida Senate - 1999                                  SB 1396
    16-729-99




  1         (c)  For a manufacturer who subcontracts with a

  2  manufacturer of medical devices to manufacture components of

  3  such devices, a Federal Drug Administration registration

  4  number; or

  5         (d)  For a manufacturer of medical devices whose

  6  devices are exempt from pre-market approval by the Federal

  7  Drug Administration, a Federal Drug Administration

  8  registration number.

  9         Section 2.  This act shall take effect July 1, 1999.

10

11            *****************************************

12                          SENATE SUMMARY

13    Exempts from the requirements of ss. 499.015 and
      499.041(6), F.S., pertaining to the registration of
14    drugs, devices, and cosmetics, each manufacturer of
      medical devices that are approved by, registered with,
15    and listed with the federal Food and Drug Administration.
      Requires each such manufacturer to submit certain
16    documents with the manufacturer's application for a
      permit to do business in this state.
17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

                                  2