IA #95-03, 9/28/93
TYPE OF ALERT: Surveillance
PRODUCT : Low Level Laser Therapy (LLLT) Devices
PRODUCT CODE : 95L--99
HARMONIZED
CODE : 9013
PROBLEM : Fails to meet the Performance Standard (DVPS)
PAC FOR
COLLECTION : 82001
COUNTRIES : All - including but not limited to Denmark,
France, Italy, and other European nations, Japan,
China, and Canada
MANUFACTURER/
SHIPPER : All
MANUFACTURER/
SHIPPER I.D.#: N/A
IMPORTER'S
I.D. # : N/A
CHARGES : For a device that is noncompliant with applicable
standard and/or lacks certification, charge:
"The article is subject to refusal of admission
pursuant to Section 536(a) of the Federal Food,
Drug, and Cosmetic Act (FFD&C Act) in that it
appears to be an electronic product which fails to
comply with an applicable standard prescribed
under this subchapter or to which is not affixed a
certification in the form of a label or tag in
conformity with Section 534(h)."
For devices found not to be under Institutional
Review Board oversight, charge:
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears
to be a device for investigational use for which
no exemption has been granted as prescribed by
Section 520(g) [Adulteration, Section 501(i)]."
For devices labeled for veterinary use contact the
Case Guidance Branch, HFV-236, (301-594-1785), the
Center for Veterinary Medicine (CVM), who will
determine violations of the Act and appropriate
charges on a case-by-case basis.
RECOMMENDING
OFFICE : CDRH, Office of Compliance and Surveillance,
Division of Enforcement III, Non-Medical
Radiological Devices Branch (NMRDB), HFZ-312 and
CVM, Case Guidance Branch, HFV-236
REASON FOR
ALERT : There is reason to believe that various LLLT
devices (also known as laser biostimulation
devices, "cold" lasers, or "soft" lasers) intended
for foreign markets, are being imported into this
country.
These products may be noncompliant with the
performance standard for laser products (21 CFR
1040.10 and 1040.11), not certified (21 CFR
1010.2), and not reported to this agency.
In addition, since low level laser therapy is
unproven medical treatment, these devices are also
investigational medical devices which may only be
distributed to investigators for the purpose of
conducting studies of this modality of treatment.
These investigators must have valid Institutional
Review Board (IRB) oversight of their studies.
Distribution of these devices to any other
individuals, would constitute commercialization of
the devices. It is believed the LLLT devices are
often illegally distributed to such individuals,
and that they are often not labeled in accordance
with 21 CFR 812.5. The situation is complicated
by the fact that there are some investigators
doing serious studies of this type of treatment.
Also, some units are intended for veterinary use,
in which case no Investigational Device Exemption
or IRB approval is required.
If promotional literature accompanies the devices,
this may indicate the intended uses of the
devices, and may aid in determining whether the
products are for human use, and whether they are
being commercialized.
INSTRUCTIONS : All shipments of Low Level Laser Therapy devices
should be inspected.
The presence of certification labels (both human
and veterinary use) will indicate that the units
comply with the standard and have been reported as
required.
The presence of Investigational Device labeling
may indicate that the units are being properly
distributed, but the consignee should still be
questioned to determine that he/she has valid IRB
oversight.
Detain all units lacking certification
investigational device, or veterinary use
labeling. Detain the device if the consignee
fails to have a valid IRB.
The name and address of the manufacturer, the
importer, the IRB and the sponsor should be
determined, if possible, and submitted to the
Acting Director, Division of Enforcement III,
Attn. NMRDB, 2098 Gaither Road, Rockville, MD
20850 (301) 594-4646.
In events where there is the presence of
veterinary labeling, CVM will have authority to
determine whether the device is adulterated,
misbranded or otherwise hazardous and unsafe. This
will be determined on a case-by-case basis.
Contact the Case Guidance Branch, HFV-236 (301-
594-1785), the Center for Veterinary Medicine
(CVM).
PRIORITIZATION
GUIDANCE : N/A
FOI : No purging is required
KEYWORDS : Low Level Laser Therapy Devices, LLLT Devices,
Laser Biostimulation Devices, Cold Lasers, Soft
Lasers
PREPARED BY : Linda A. Wisniowski, DIOP, 301-443-6553.
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