Senate Bill 1396e1
CODING: Words stricken are deletions; words underlined are additions.
SB 1396 First Engrossed
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., 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.
12
13 Be It Enacted by the Legislature of the State of Florida:
14
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
1
CODING: Words stricken are deletions; words underlined are additions.
SB 1396 First 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.
18
19
20
21
22
23
24
25
26
27
28
29
30
31
2