House Bill 0431

    Florida House of Representatives - 1999                 HB 431

        By Representative Lynn






  1                      A bill to be entitled

  2         An act relating to drugs, devices, and

  3         cosmetics; amending s. 499.015, F.S.; providing

  4         an exemption from state registration

  5         requirements for medical devices registered,

  6         listed, and approved under federal regulations;

  7         requiring certain evidence upon application to

  8         do business in the state; amending s. 499.041,

  9         F.S.; providing an exemption from the annual

10         product registration fee; providing an

11         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 other requirements in ss.

20  499.001-499.081, medical device manufacturers whose Class II

21  and Class III devices are approved by and registered and

22  listed with the United States Food and Drug Administration are

23  exempt from the provisions of this section and s. 499.041(6).

24  However, the medical device manufacturer must submit evidence

25  of such registration, listing, and approval at the time it

26  submits its application for a permit to do business in the

27  state, as required in s. 499.013(2)(d), which evidence shall

28  include:

29         (a)  A copy of the premarket notification letter (510K)

30  for Class II devices;

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






    Florida House of Representatives - 1999                 HB 431

    560-201-99






  1         (b)  The premarket approval number for Class III

  2  devices; or

  3         (c)  The registration number for subcontract medical

  4  device manufacturers who manufacture components of devices for

  5  manufacturers.

  6         Section 2.  Subsection (6) of section 499.041, Florida

  7  Statutes, is amended to read:

  8         499.041  Schedule of fees for drug, device, and

  9  cosmetic applications and permits, investigational drug

10  applications, product registrations, and free-sale

11  certificates; trust fund.--

12         (6)  A person that is required to register drugs,

13  devices, or cosmetic products under s. 499.015 shall pay an

14  annual product registration fee of not less than $5 or more

15  than $15 for each separate and distinct product in package

16  form.  The registration fee is in addition to the fee charged

17  for a free-sale certificate. A person that is required to

18  register devices under s. 499.015 is exempt from paying the

19  annual product registration fee under this subsection but is

20  not exempt from paying the free-sale certificate fee.

21         Section 3.  This act shall take effect July 1, 1999.

22

23            *****************************************

24                          HOUSE SUMMARY

25
      Exempts medical devices approved by and registered and
26    listed with the United States Food and Drug
      Administration from state drug, device, and cosmetic
27    registration requirements. Eliminates annual product
      registration fee requirements for persons registering
28    medical devices in the state.

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