Import Alert 89-11
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) 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).
Import Alert # 89-11
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Class III Devices Without PMAs or PDPs"
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.
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 the guidance section of this alert below, should contact CDRH, Office of Compliance, Division of Enforcement II 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].
Device 21 CFR Effective Date*
Implanted Cerebella 882.5820 9/26/84
Stimulator
Implanted 882.5830 07/07/86
Diaphragmatic/
Phrenic Nerve Stimulator
Replacement 870.3925 12/09/87
Heart Valve
Contraceptive Tubal 884.5380 12/31/87
Occlusion Device and
Introducer
Contraceptive 884.5360 08/04/86
Intrauterine
Device (IUD) and Introducer
Transabdominal 884.1600 01/29/87
Amnioscope
(Fetoscope) and Accessories
Implanted 882.5840 03/01/89
Intracerebral/
Subcortical Stimulator for
Pain Relief
Silicone Gel- 874.3540 05/04/90
Filled Breast
Prosthesis
***Dry Heat 872.6730 4/21/97
(glass bead)
Sterilizer***
* Date after which PMA or PDP is required.
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].
Device 21 CFR Effective Date*
Implanted Cerebella 882.5820 9/26/84
Stimulator
Implanted 882.5830 07/07/86
Diaphragmatic/
Phrenic Nerve Stimulator
Replacement 870.3925 12/09/87
Heart Valve
Contraceptive Tubal 884.5380 12/31/87
Occlusion Device and
Introducer
Contraceptive 884.5360 08/04/86
Intrauterine
Device (IUD) and Introducer
Transabdominal 884.1600 01/29/87
Amnioscope
(Fetoscope) and Accessories
Implanted 882.5840 03/01/89
Intracerebral/
Subcortical Stimulator for
Pain Relief
Silicone Gel- 874.3540 05/04/90
Filled Breast
Prosthesis
***Dry Heat 872.6730 4/21/97
(glass bead)
Sterilizer***
* Date after which PMA or PDP is required.
Product Description:
Class III devices (See Guidance section of this alert)
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
OASIS charge code - NO PMA
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