IA #89-11, REVISION 11/3/99 - IMPORT ALERT 89-11, DETENTION WITHOUT
PHYSICAL EXAMINATION OF CLASS III DEVICES WITHOUT PMAs
OR PDPs"
This import alert is being revised to reflect current terminology and to add a
new class III device to the attachment. Changes have been bracketed by
asterisks ***.
TYPE OF ALERT: ***Detention Without Physical Examination***
***(Note: This import alert contains guidance to FDA field personnel regarding
the manufacturer and products at issue. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public.)***
PRODUCTS : Class III devices (See Attachment)
PROBLEM : Class III devices for which no application for
premarket approval (PMA) or notice of completion of
a product development protocol (PDP) has been filed
as required by Section 515(b) of the Act.
CHARGE : "The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that the device appears to
be a class III device and does not appear to have in effect
an application for premarket approval or notice of
completion of a product development protocol filed in
accordance with Section 515(b) of the Act, or an exemption
pursuant to Section 520(g)(1). [Adulteration, Section
501(f)(1)(A)]."
OASIS
CHARGE CODE : NO PMA/PDP
RECOMMENDING
OFFICE : ***CDRH, Office of Compliance, Division of
Enforcement II***
REASON FOR
ALERT : Devices listed in the Attachment have been
identified by CDRH/Office of Compliance as being
the subject of a 515(b) notice and lack either a
filed application for PMA or a notice of completion
of a PDP for commercial distribution.
GUIDANCE : ***Districts encountering devices identified as
having product classifications referenced in
Attachment A of this alert, should contact CDRH,
Office of Compliance, Division of Enforcement II
(301) 594-4613 to determine if detention without
physical examination may be appropriate.
Devices from specific firms, which have complied
with the PMA or PDP filing, will be listed in
Attachment B and should be released. [Note: At
this time there are no firms meeting this
criteria].
Specific firms may be excluded from ***detention
without physical examination*** when CDRH has
reported that they are in compliance and have filed
an application for PMA or a notice of completion of
a PDP. See Attachment C. [Note: At this time
there are no firms meeting this criteria].
FOI : No purging is required.
Prepared by: Fredda Shere-Valenti, DIOP, (301) 443-6553
Keywords: PDP, PMA, Class III
Date Loaded Into FIARS: November 3, 1999
ATTACHMENT A TO IMPORT ALERT #89-11 11/3/99
The following devices are under ***detention without physical examination:***
Device 21 CFR Effective Date*
Implanted Cerebella 882.5820 09/26/84
Stimulator
Implanted Diaphragmatic/ 882.5830 07/07/86
Phrenic Nerve Stimulator
Replacement Heart Valve 870.3925 12/09/87
Contraceptive Tubal 884.5380 12/31/87
Occlusion Device and
Introducer
Contraceptive Intrauterine 884.5360 08/04/86
Device (IUD) and Introducer
Transabdominal Amnioscope 884.1600 01/29/87
(Fetoscope) and Accessories
Implanted Intracerebral/ 882.5840 03/01/89
Subcortical Stimulator for
Pain Relief
Silicone Gel-Filled Breast 874.3540 05/04/90
Prosthesis
***Dry Heat (glass bead) 872.6730 04/21/97
Sterilizer***
* Date after which PMA or PDP is required.
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