CODING: Words stricken are deletions; words underlined are additions.
HOUSE AMENDMENT
Bill No. HB 431
Amendment No. 1 (for drafter's use only)
CHAMBER ACTION
Senate House
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5 ORIGINAL STAMP BELOW
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11 The Committee on Health Care Licensing & Regulation offered
12 the following:
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14 Amendment (with title amendment)
15 Remove from the bill: Everything after the enacting clause
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17 and insert in lieu thereof:
18 Section 1. Subsections (8) and (9) are added to
19 section 499.015, Florida Statutes, 1998 Supplement, to read:
20 499.015 Registration of drugs, devices, and cosmetics;
21 issuance of certificates of free sale.--
22 (8) Notwithstanding any requirements set forth in ss.
23 499.001-499.081, a manufacturer of medical devices that is
24 registered with the United State Food and Drug Administration
25 is exempt from this section and s. 499.041(6), if:
26 (a) The manufacturer's medical devices are approved
27 for marking by, or listed with the United States Food and Drug
28 Administration in accordance with federal law for commercial
29 distributions; or
30 (b) The manufacturer subcontracts with a manufacturer
31 of medical devices to manufacture components of such devices.
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File original & 9 copies 03/22/99
hcs0005 06:11 pm 00431-hcl -613327
HOUSE AMENDMENT
Bill No. HB 431
Amendment No. 1 (for drafter's use only)
1 (9) However, the manufacturer must submit evidence of
2 such registration, listing, or approval with its initial
3 application for a permit to do business in this state, as
4 required in s. 499.013 and any changes to such information
5 previously submitted at the time of renewal of the permit.
6 Evidence of approval, listing and registration by the United
7 States Food and Drug Administration must include:
8 (a) For Class II devices, a copy of the pre-market
9 notification letter (510K);
10 (b) For Class III devices, a Federal Drug
11 Administration pre-market approval number;
12 (c) For a manufacturer who subcontracts with a
13 manufacturer of medical devices to manufacture components of
14 such devices, a Federal Drug Administration registration
15 number; or
16 (d) For a manufacturer of medical devices whose
17 devices are exempt from pre-market approval by the Federal
18 Drug Administration, a Federal Drug Administration
19 registration number.
20 Section 2. This act shall take effect July 1, 1999.
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23 ================ T I T L E A M E N D M E N T ===============
24 And the title is amended as follows:
25 On page 1, lines 1-11,
26 remove everything in the title of the bill:
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28 and insert in lieu thereof:
29 A bill to be entitled
30 An act relating to the registration of drugs,
31 devices, and cosmetics; amending s. 499.015,
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File original & 9 copies 03/22/99
hcs0005 06:11 pm 00431-hcl -613327
HOUSE AMENDMENT
Bill No. HB 431
Amendment No. 1 (for drafter's use only)
1 F.S.; exempting from ss. 499.015, 499.041 (6),
2 F.S., manufacturers of medical devices that
3 meet specific requirements of the federal Food
4 and Drug Administration; requiring certain
5 manufacturer's application for a permit to do
6 business in this state; providing an effective
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File original & 9 copies 03/22/99
hcs0005 06:11 pm 00431-hcl -613327