[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Rules and Regulations]
[Pages 57321-57323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23304]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA-2019-N-2675]
Medical Devices; Physical Medicine Therapeutic Devices;
Classification of the Internal Therapeutic Massager
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the internal therapeutic massager into class II (special controls). The
special controls that apply to the device type are identified in this
order and will be part of the codified language for the internal
therapeutic massager's classification. We are taking this action
because we have determined that classifying the device into class II
(special controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe
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this action will also enhance patients' access to beneficial innovative
devices, in part by reducing regulatory burdens.
DATES: This order is effective October 25, 2019. The classification was
applicable on November 20, 2012.
FOR FURTHER INFORMATION CONTACT: Vivek Pinto, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2668, Silver Spring, MD, 20993-0002, 301-796-1136,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the internal therapeutic massager
as class II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness. In addition, we
believe this action will enhance patients' access to beneficial
innovation, in part by reducing regulatory burdens by placing the
device into a lower device class than the automatic class III
assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k) and Part 807 (21 CFR part 807), respectively.
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug
Administration Modernization Act of 1997 established the first
procedure for De Novo classification (Pub. L. 105-115). Section 607 of
the Food and Drug Administration Safety and Innovation Act modified the
De Novo application process by adding a second procedure (Pub. L. 112-
144). A device sponsor may utilize either procedure for De Novo
classification.
Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device
was automatically within class III, the De Novo classification is
considered to be the initial classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the 510(k) process, when
necessary, to market their device.
II. De Novo Classification
For this device, FDA issued an order on July 27, 2010, finding the
American Health Insurance Plans (AHIP) Internal Trigger Point Wand not
substantially equivalent to a predicate not subject to premarket
approval. Thus, the device remained in class III in accordance with
section 513(f)(1) of the FD&C Act when we issued the order.
On August 20, 2010, National Center for Pelvic Pain Research
Devices, Inc. submitted a request for De Novo classification of the
AHIP Internal Trigger Point Wand. FDA reviewed the request in order to
classify the device under the criteria for classification set forth in
section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on November 20, 2012, FDA issued an order to the
requester classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 890.5670. We have named
the generic type of device internal therapeutic massager, and it is
identified as a hand-held prescription device intended for medical
purposes to manually provide direct pressure applied to localized areas
of pain or tenderness in the myofascial tissue associated with chronic
pelvic pain syndromes. The device is inserted rectally or vaginally and
provides quantitative feedback to the user of the applied force to the
target tissue.
FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.
Table 1--Internal Therapeutic Massager Risks and Mitigation Measures
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Identified risks Mitigation measures
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Adverse tissue reaction................ Biocompatibility evaluation,
and Labeling.
Tissue bruising, abrasion or tearing... Non-clinical performance
testing, and Labeling.
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Microbial contamination from reusable Labeling.
components.
Vaginal/rectal cross-contamination..... Labeling.
Overstretching/weakness of the anal Non-clinical performance
sphincter and vagina. testing, and Labeling.
Mechanical failure during use.......... Non-clinical performance
testing.
User error............................. Labeling.
Electrical shock....................... Electrical safety testing, and
Labeling.
Electromagnetic incompatibility........ Electromagnetic compatibility
testing, and Labeling.
Software failure....................... Software verification,
validation, and hazard
analysis.
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FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k) of the FD&C Act.
At the time of classification, internal therapeutic massagers are
for prescription use only. Prescription devices are exempt from the
requirement for adequate directions for use for the layperson under
section 502(f)(1) of the FD&C Act and 21 CFR 801.5, as long as the
conditions of 21 CFR 801.109 are met (referring to 21 U.S.C.
352(f)(1)).
Section 510(m)(2) of the FD&C Act provides that FDA may exempt a
class II device from the premarket notification requirements under
section 510(k) if, after notice of our intent to exempt and
consideration of comments, we determine by order that premarket
notification is not necessary to provide reasonable assurance of safety
and effectiveness of the device. We believe this may be such a device.
The notice of intent to exempt the device from premarket notification
requirements is published elsewhere in this issue of the Federal
Register.
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; the collections of
information in part 814, subparts A through E, regarding premarket
approval, have been approved under OMB control number 0910-0231; the
collections of information in part 807, subpart E, regarding premarket
notification submissions, have been approved under OMB control number
0910-0120; and the collections of information in part 801, regarding
labeling, have been approved under OMB control number 0910-0485.
List of Subjects in 21 CFR Part 890
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
890 is amended as follows:
PART 890--PHYSICAL MEDICINE DEVICES
0
1. Add an authority citation for part 890 to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 890.5670 to subpart F to read as follows:
Sec. 890.5670 Internal therapeutic massager.
(a) Identification. A hand-held internal therapeutic massager
device is a prescription device intended for medical purposes to
manually provide direct pressure applied to localized areas of pain or
tenderness in the myofascial tissue associated with chronic pelvic pain
syndromes. The device is inserted rectally or vaginally and provides
quantitative feedback to the user of the applied force to the target
tissue.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Labeling must include adequate directions for use.
(2) Non-clinical performance testing must demonstrate
electromagnetic compatibility (EMC), electrical safety and mechanical
safety.
(3) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following performance characteristics must be tested:
(i) Mechanical durability; and
(ii) Accuracy of the feedback mechanism.
(4) Software verification, validation, and hazard analysis must be
performed.
(5) The patient-contacting components of the device must be
demonstrated to be biocompatible.
Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23304 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P