Senate Bill 1396er

    ENROLLED

    1999 Legislature                        SB 1396, 1st Engrossed



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  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., manufacturers of medical devices that

  6         meet specified requirements of the federal Food

  7         and Drug Administration; requiring certain

  8         information to be submitted with such a

  9         manufacturer's application for a permit to do

10         business in this state; providing an effective

11         date.

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

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15         Section 1.  Subsections (8) and (9) are added to

16  section 499.015, 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 is

21  registered with the federal Food and Drug Administration is

22  exempt from this section and s. 499.041(6) if:

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

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

25  Administration in accordance with federal law for commercial

26  distribution; or

27         (b)  The manufacturer subcontracts with a manufacturer

28  of medical devices to manufacture components of such devices.

29         (9)  However, the manufacturer must submit evidence of

30  such registration, listing, or approval with its initial

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


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




    ENROLLED

    1999 Legislature                        SB 1396, 1st Engrossed



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

  6  notification letter (510K);

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

  8  Administration pre-market approval number;

  9         (c)  For a manufacturer who subcontracts with a

10  manufacturer of medical devices to manufacture components of

11  such devices, a Federal Drug Administration registration

12  number; or

13         (d)  For a manufacturer of medical devices whose

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

15  Drug Administration, a Federal Drug Administration

16  registration number.

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

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