[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Rules and Regulations]
[Pages 72589-72591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29633]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2015-P-1197]


Medical Devices; Exemption From Premarket Notification; Class II 
Devices; Electric Positioning Chair

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
publishing an order granting a petition requesting exemption from 
premarket notification requirements for electric positioning chair 
devices. An electric positioning chair is a device with a motorized 
positioning control that is intended for medical purposes and that can 
be adjusted to various positions. These devices are used to provide 
stability for patients with athetosis (involuntary spasms) and to alter 
postural positions. This order exempts electric positioning chairs, 
class II devices, from premarket notification, subject to certain 
conditions for exemption. This exemption from premarket notification, 
subject to these conditions (and the limitations in the physical 
medicine devices limitations of exemptions from premarket notification 
section of the device regulations), is immediately in effect for 
electric positioning chairs. FDA is publishing this order in accordance 
with the exemption from class II premarket notification section of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act).

DATES: This order is effective November 20, 2015.

FOR FURTHER INFORMATION CONTACT: John Marszalek, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1427, Silver Spring, MD 20993, 301-796-7067.

SUPPLEMENTARY INFORMATION: 

I. Statutory Background

    Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and its 
implementing regulations (21 CFR part 807) require persons who propose 
to begin the introduction or delivery for introduction into interstate 
commerce for commercial distribution of a device intended for human use 
to submit a premarket notification (510(k)) to FDA. The device may not 
be marketed until FDA finds it ``substantially equivalent'' within the 
meaning of section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a 
legally marketed device that does not require premarket approval.
    On November 21, 1997, the President signed into law the Food and 
Drug Administration Modernization Act of 1997 (FDAMA). Section 206 of 
FDAMA added section 510(m) to the FD&C Act. Section 510(m)(1) of the 
FD&C Act requires FDA, within 60 days after enactment of FDAMA, to 
publish in the Federal Register a list of each type of class II device 
that does not require a report under section 510(k) of the FD&C Act to 
provide reasonable assurance of safety and effectiveness. Section 
510(m) of the FD&C Act further provides that a 510(k) will no longer be 
required for these devices upon the date of publication of the list in 
the Federal Register. FDA published that list in the Federal Register 
of January 21, 1998 (63 FR 3142).
    Section 510(m)(2) of the FD&C Act provides that FDA may exempt a 
device from premarket notification requirements on its own initiative, 
or upon petition of an interested person, if FDA determines that a 
510(k) is not necessary to assure the safety and effectiveness of the 
device. This section requires FDA to publish in the Federal Register a 
notice of intent to exempt a device, or of the petition, and to provide 
a 30-day comment period. FDA must publish in the Federal Register its 
final determination regarding the exemption of the device that was the 
subject of the notice. If FDA fails to respond to a petition under this 
section within 180 days of receiving it, the petition shall be deemed 
granted.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether 
a 510(k) is necessary to assure the safety and effectiveness of a class 
II device. These factors are discussed in the guidance that the Agency 
issued on February 19, 1998, entitled ``Procedures for Class II Device 
Exemptions From Premarket Notification, Guidance for Industry and CDRH 
Staff'' (Class II 510(k) Exemption Guidance). That guidance can be 
obtained through the Internet on the Center for Devices and 
Radiological Health home page at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm or by 
sending an email request to [email protected] to receive a copy 
of the document. Please use the document number 159 to identify the 
guidance you are requesting.

III. Device Description

    Electric positioning chairs are devices with a motorized 
positioning control that are intended for medical purposes and that can 
be adjusted to various positions. Existing legally marketed devices 
have identified a range of specific procedures or conditions for which 
an electric positioning chair could be used to provide stability and to 
alter postural positions (e.g., muscular dystrophy, Parkinson's 
syndrome, or joint replacements). The devices are primarily intended to 
provide stability and a controlled lift from a seated position to a 
standing position, while supporting the patient's weight (alter 
postural positions). The device consists of a frame (where the user 
would sit) and a lift mechanism, and may also allow the patient to 
recline in the device.

IV. Petition

    On April 10, 2015, FDA received a petition requesting an exemption 
from premarket notification for electric positioning chair devices. 
(See Docket No. FDA-2015-P-1197.) These devices are currently 
classified under 21 CFR 890.3110 Electric positioning chair.
    In the Federal Register of June 12, 2015 (80 FR 33525), FDA 
published a notice announcing that this petition had been received and 
provided opportunity for interested persons to submit comments on the 
petition by July 13, 2015. FDA received no comments.
    FDA has assessed the need for 510(k) clearance for this type of 
device using the criteria laid out in the Class II 510(k) Exemption 
Guidance and in the January 21, 1998, notice (63 FR 3142 at 3143). 
Based on its review, FDA believes that premarket notification is not 
necessary to assure the safety and effectiveness of the device, as long 
as certain conditions are met. FDA believes that the risks posed by the 
device (such as instability, entrapment, use error, falls and 
associated injuries, battery/electrical/mechanical failure, pressure 
sores, bruising, burns, electric shock, and

[[Page 72590]]

electromagnetic incompatibility/interference) and the characteristics 
of the device necessary for its safe and effective performance (such as 
safety features, weight capacity, power source, drive mechanism/
actuator, and user controls) are well established. Moreover, FDA 
believes that changes in the device that could affect safety and 
effectiveness will be readily detectable by certain types of routine 
analysis and non-clinical testing, such as those detailed in certain 
consensus standards. Therefore, after reviewing the petition, FDA has 
determined that premarket notification is not necessary to assure the 
safety and effectiveness of electric positioning chairs, as long as the 
conditions for 510(k) exemption in section V are met. FDA responded to 
the petition by letter dated October 9, 2015, to inform the petitioner 
of this decision within the 180-day timeframe under section 510(m)(2) 
of the FD&C Act.

V. Conditions for Exemption

    This final order provides conditions for exemption from premarket 
notification. The following conditions must be met for the device to be 
510(k)-exempt: (1) Appropriate analysis and non-clinical testing must 
demonstrate that the safety controls are adequate to ensure safe use of 
the device and prevent user falls from the device in the event of a 
device failure; (2) appropriate analysis and non-clinical testing must 
demonstrate the ability of the device to withstand the rated user 
weight load with an appropriate factor of safety; (3) appropriate 
analysis and non-clinical testing must demonstrate the longevity of the 
device to withstand external forces applied to the device and provide 
the user with an expected service life of the device; (4) appropriate 
analysis and non-clinical testing must demonstrate proper environments 
of use and storage of the device to maximize the longevity of the 
device; (5) appropriate analysis and non-clinical testing (such as that 
outlined in the currently FDA-recognized editions of ANSI/AAMI ES60601-
1: ``Medical Electrical Equipment--Part 1: General Requirements for 
Basic Safety and Essential Performance,'' and ANSI/AAMI/IEC 60601-1-2, 
``Medical Electrical Equipment--Part 1-2: General Requirements for 
Basic Safety and Essential Performance--Collateral Standard: 
Electromagnetic Disturbances--Requirements and Tests'') must validate 
electromagnetic compatibility and electrical safety; (6) appropriate 
analysis and non-clinical testing (such as that outlined in the 
currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, 
``Biological Evaluation of Medical Devices--Part 1: Evaluation and 
Testing Within a Risk Management Process,'' ANSI/AAMI/ISO 10993-5, 
``Biological Evaluation of Medical Devices--Part 5: Tests for In Vitro 
Cytotoxicity,'' and ANSI/AAMI/ISO 10993-10, ``Biological Evaluation of 
Medical Devices--Part 10: Tests for Irritation and Skin 
Sensitization'') must validate that the skin-contacting components of 
the device are biocompatible; (7) appropriate analysis and non-clinical 
testing (such as that outlined in the currently FDA-recognized editions 
of IEC 62304, ``Medical Device Software--Software Life Cycle 
Processes'') must validate the software life cycle and that all 
processes, activities, and tasks are implemented and documented; (8) 
appropriate analysis and non-clinical testing must validate that the 
device components are found to be non-flammable; (9) appropriate 
analysis and non-clinical testing must validate that the battery in the 
device (if applicable) performs as intended over the anticipated 
service life of the device; and (10) adequate patient labeling is 
provided to the user to document proper use and maintenance of the 
device to ensure safe use of the device by the patient in the intended 
use environment.
    Firms are now exempt from 510(k) requirements for electric 
positioning chairs as long as they meet these conditions of exemption, 
subject to the limitations in 21 CFR 890.9. Firms must comply with the 
conditions for exemption or submit and receive clearance for a 510(k) 
prior to marketing.

VI. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) 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.

VII. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of 
information found in FDA regulations. 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. 3501-3520). The 
collections of information in 21 CFR part 801, regarding medical device 
labeling, have been approved under OMB control number 0910-0485 and the 
collections of information in 21 CFR part 820, regarding the quality 
system regulation, have been approved under OMB control number 0910-
0073.

List of Subjects in 21 CFR Part 890

    Medical devices, Physical medicine 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. The authority citation for 21 CFR part 890 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. In Sec.  890.3110, revise paragraph (b) to read as follows:


Sec.  890.3110  Electric positioning chair.

* * * * *
    (b) Classification. Class II. The electric positioning chair is 
exempt from premarket notification procedures in subpart E of part 807 
of this chapter, subject to Sec.  890.9 and the following conditions 
for exemption:
    (1) Appropriate analysis and non-clinical testing must demonstrate 
that the safety controls are adequate to ensure safe use of the device 
and prevent user falls from the device in the event of a device 
failure;
    (2) Appropriate analysis and non-clinical testing must demonstrate 
the ability of the device to withstand the rated user weight load with 
an appropriate factor of safety;
    (3) Appropriate analysis and non-clinical testing must demonstrate 
the longevity of the device to withstand external forces applied to the 
device and provide the user with an expected service life of the 
device;
    (4) Appropriate analysis and non-clinical testing must demonstrate 
proper environments of use and storage of the device to maximize the 
longevity of the device;
    (5) Appropriate analysis and non-clinical testing (such as that 
outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-
1, ``Medical Electrical Equipment--Part 1: General Requirements for 
Basic Safety and Essential Performance,'' and ANSI/AAMI/IEC 60601-1-2, 
``Medical Electrical Equipment--Part 1-2: General Requirements for 
Basic Safety and Essential Performance--Collateral Standard: 
Electromagnetic Disturbances--Requirements and Tests'') must validate 
electromagnetic compatibility and electrical safety;
    (6) Appropriate analysis and non-clinical testing (such as that 
outlined in

[[Page 72591]]

the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, 
``Biological Evaluation of Medical Devices--Part 1: Evaluation and 
Testing Within a Risk Management Process,'' ANSI/AAMI/ISO 10993-5, 
``Biological Evaluation of Medical Devices--Part 5: Tests for In Vitro 
Cytotoxicity,'' and ANSI/AAMI/ISO 10993-10, ``Biological Evaluation of 
Medical Devices--Part 10: Tests for Irritation and Skin 
Sensitization'') must validate that the skin-contacting components of 
the device are biocompatible;
    (7) Appropriate analysis and non-clinical testing (such as that 
outlined in the currently FDA-recognized editions of IEC 62304, 
``Medical Device Software--Software Life Cycle Processes'') must 
validate the software life cycle and that all processes, activities, 
and tasks are implemented and documented;
    (8) Appropriate analysis and non-clinical testing must validate 
that the device components are found to be non-flammable;
    (9) Appropriate analysis and non-clinical testing must validate 
that the battery in the device (if applicable) performs as intended 
over the anticipated service life of the device; and
    (10) Adequate patient labeling is provided to the user to document 
proper use and maintenance of the device to ensure safe use of the 
device by the patient in the intended use environment.

     Dated: November 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29633 Filed 11-19-15; 8:45 am]
 BILLING CODE 4164-01-P