80 FR 9600 - Medical Devices; Physical Medicine Devices; Classification of the Powered Exoskeleton
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 36 (February 24, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 36 (February 24, 2015)
| Page Range | 9600-9603 | |
| FR Document | 2015-03692 |
[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)] [Rules and Regulations] [Pages 9600-9603] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03692] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 890 [Docket No. FDA-2014-N-1903] Medical Devices; Physical Medicine Devices; Classification of the Powered Exoskeleton AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the powered exoskeleton into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the powered exoskeleton's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective March 26, 2015. The classification was applicable on June 26, 2014. FOR FURTHER INFORMATION CONTACT: Michael Hoffmann, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1434, Silver Spring, MD 20993-0002, 301- 796-6476, Michael.Hoffmann@fda.hhs.gov. [[Page 9601]] SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Public Law 112- 144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of ``low-moderate risk'' or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. On June 22, 2013, Argo Medical Technologies, Inc., submitted a request for classification of the ReWalk under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1). In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies 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 to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on June 26, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 890.3480. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a powered exoskeleton will need to comply with the special controls named in this final order. The device is assigned the generic name powered exoskeleton, and it is identified as a prescription device that is composed of an external, powered, motorized orthosis used for medical purposes that is placed over a person's paralyzed or weakened limbs for the purpose of providing ambulation. FDA has identified the following risks to health associated specifically with this type of device, as well as the measures required to mitigate these risks in table 1. Table 1--Powered Exoskeleton Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation measure ------------------------------------------------------------------------ Instability, falls, and associated Clinical testing. injuries. Training. Software verification, validation, and hazard analysis. Wireless testing. Electromagnetic compatibility (EMC) and electromagnetic interference (EMI) testing. Electrical safety testing. Design characteristics. Non-clinical performance testing. Water/particle ingress testing. Durability testing. Battery testing. Labeling. Bruising, skin abrasion, pressure Clinical testing. sores, soft tissue injury. Training. Labeling. Diastolic hypertension and changes in Clinical testing. blood pressure, and heart rate. Training. Labeling. Adverse tissue reaction................ Biocompatibility assessment. Premature battery failure.............. Battery testing. Labeling. Interference with other electrical EMC/EMI testing. equipment/devices. Labeling. [[Page 9602]] Burns, electrical shock................ Electrical safety testing. Thermal testing. Labeling. Device malfunction resulting in Clinical testing. unanticipated operation (e.g., device stoppage, unintended movement). Non-clinical performance testing. Training. Software verification, validation, and hazard analysis. Electrical safety testing. Battery testing. Water/particle ingress testing. Wireless testing. EMC/EMI testing. Flammability testing. Labeling. Use error.............................. Clinical testing. Training. Labeling. ------------------------------------------------------------------------ FDA believes that the following special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness:Elements of the device materials that may contact the patient must be demonstrated to be biocompatible. Appropriate analysis/testing must validate electronic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable. Appropriate software verification, validation, and hazard analysis must be performed. Design characteristics must ensure geometry and materials composition are consistent with intended use. Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include: [cir] Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use; [cir] simulated use testing (i.e., cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing; [cir] verification and validation of manual override controls are necessary, if present; [cir] the accuracy of device features and safeguards; and [cir] device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance. Clinical testing must demonstrate safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for: [cir] Level of supervision necessary and [cir] environment of use (e.g., indoors and/or outdoors), including obstacles and terrain representative of the intended use environment. A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can: [cir] Identify the safe environments for device use, [cir] use all safety features of device, and [cir] operate the device in simulated or actual use environments representative of indicated environments and use. Labeling for the Physician and User must include the following: [cir] Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk; [cir] specific instructions and the clinical training needed for the safe use of the device, which includes: [ssquf] Instructions on assembling the device in all available configurations; [ssquf] instructions on fitting the patient; [ssquf] instructions and explanations of all available programs and how to program the device; [ssquf] instructions and explanation of all controls, input, and outputs; [ssquf] instructions on all available modes or states of the device; [ssquf] instructions on all safety features of the device; and [ssquf] instructions for properly maintaining the device; [cir] Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness; [cir] pertinent non-clinical testing information (e.g., EMC, battery longevity); and [cir] a detailed summary of the clinical testing including: [ssquf] Adverse events encountered under use conditions, [ssquf] summary of study outcomes and endpoints, and [ssquf] information pertinent to use of the device including the conditions under which the device was studied (e.g., level of supervision or assistance, and environment of use (e.g., indoors and/or outdoors) including obstacles and terrain). Powered exoskeleton devices are restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; see section 520(e) of the FD&C Act (21 U.S.C. 360j(e)) and 21 CFR 801.109 (Prescription devices). Prescription-use restrictions are a type of general controls as defined in section 513(a)(1)(A)(i) of the FD&C Act. Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device [[Page 9603]] must submit to FDA a premarket notification, prior to marketing the device, which contains information about the powered exoskeleton they intend to market. II. 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. III. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other 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 part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485. IV. Reference The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at http://www.regulations.gov. 1. K131798: De Novo Request per 513(f)(2) from Argo Medical Technologies, Inc., dated June 22, 2013. 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. Add Sec. 890.3480 to subpart D to read as follows: Sec. 890.3480 Powered exoskeleton. (a) Identification. A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis used for medical purposes that is placed over a person's paralyzed or weakened limbs for the purpose of providing ambulation. (b) Classification. Class II (special controls). The special controls for this device are: (1) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible. (2) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable. (3) Appropriate software verification, validation, and hazard analysis must be performed. (4) Design characteristics must ensure geometry and materials composition are consistent with intended use. (5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include: (i) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use; (ii) Simulated use testing (i.e., cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing; (iii) Verification and validation of manual override controls are necessary, if present; (iv) The accuracy of device features and safeguards; and (v) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance. (6) Clinical testing must demonstrate safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for: (i) Level of supervision necessary, and (ii) Environment of use (e.g., indoors and/or outdoors) including obstacles and terrain representative of the intended use environment. (7) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can: (i) Identify the safe environments for device use, (ii) Use all safety features of device, and (iii) Operate the device in simulated or actual use environments representative of indicated environments and use. (8) Labeling for the Physician and User must include the following: (i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk. (ii) Specific instructions and the clinical training needed for the safe use of the device, which includes: (A) Instructions on assembling the device in all available configurations; (B) Instructions on fitting the patient; (C) Instructions and explanations of all available programs and how to program the device; (D) Instructions and explanation of all controls, input, and outputs; (E) Instructions on all available modes or states of the device; (F) Instructions on all safety features of the device; and (G) Instructions for properly maintaining the device. (iii) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness. (iv) Pertinent non-clinical testing information (e.g., EMC, battery longevity). (v) A detailed summary of the clinical testing including: (A) Adverse events encountered under use conditions, (B) Summary of study outcomes and endpoints, and (C) Information pertinent to use of the device including the conditions under which the device was studied (e.g., level of supervision or assistance, and environment of use (e.g., indoors and/or outdoors) including obstacles and terrain). Dated: February 18, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-03692 Filed 2-23-15; 8:45 am] BILLING CODE 4164-01-P
![9600 Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Rules and Regulations
information collection, communication Commission estimates that 30. User assistance is available for
and management within the energy approximately five percent, or twelve of eLibrary and the Commission’s Web site
industry. The Commission has assured these small entities expect to be affected during normal business hours from the
itself, by means of internal review, that by the new requirements of the Commission’s Online Support at 202–
there is specific, objective support for proposed Reliability Standard. The 502–6652 (toll free at 1–866–208–3676)
the burden estimates associated with the Commission estimates that the small or email at ferconlinesupport@ferc.gov,
information requirements. entities that will be affected by or the Public Reference Room at (202)
Interested persons may obtain Reliability Standard MOD–031–1 will 502–8371, TTY (202) 502–8659. Email
information on the reporting incur one-time compliance costs ranging the Public Reference Room at
requirements by contacting: Federal up to $14,309 (i.e. the cost of public.referenceroom@ferc.gov.
Energy Regulatory Commission, 888 determining the method of weather
First Street NE., Washington, DC 20426 normalizing annual peak hour actual VIII. Effective Date and Congressional
[Attention: Ellen Brown, Office of the demand), plus the annual development Notification
Executive Director, email: of summary narratives in accordance 31. These regulations are effective
DataClearance@ferc.gov, Phone: (202) with Requirement R1, Subparts 1.5.4 April 27, 2015. The Commission has
502–8663, fax: (202) 273–0873]. and 1.5.5, resulting in costs of $477. determined, with the concurrence of the
Comments on the requirements of this 26. Accordingly, the Commission Administrator of the Office of
rule may also be sent to the Office of certifies that the Reliability Standard Information and Regulatory Affairs of
Information and Regulatory Affairs, will not have a significant economic OMB, that this rule is not ‘‘major rule’’
Office of Management and Budget, impact on a substantial number of small as defined in section 351 of the Small
Washington, DC 20503 [Attention: Desk entities. Business Regulatory Enforcement
Officer for the Federal Energy Fairness Act of 1996.
VI. Environmental Analysis
Regulatory Commission]. For security By the Commission.
reasons, comments should be sent by 27. The Commission is required to
prepare an Environmental Assessment Issued: February 19, 2015.
email to OMB at oira_submission@
or an Environmental Impact Statement Nathaniel J. Davis, Sr.,
omb.eop.gov. Comments submitted to
OMB should refer to FERC–725L and for any action that may have a Deputy Secretary.
OMB Control No. 1902–0261. significant adverse effect on the human [FR Doc. 2015–03740 Filed 2–23–15; 8:45 am]
environment.25 The Commission has BILLING CODE 6717–01–P
V. Regulatory Flexibility Act categorically excluded certain actions
Certification from this requirement as not having a
24. The Regulatory Flexibility Act of significant effect on the human DEPARTMENT OF HEALTH AND
1980 (RFA) 21 generally requires a environment. Included in the exclusion HUMAN SERVICES
description and analysis of final rules are rules that are clarifying, corrective,
that will have significant economic or procedural or that do not Food and Drug Administration
impact on a substantial number of small substantially change the effect of the
entities. regulations being amended.26 The 21 CFR Part 890
25. The Small Business actions proposed herein fall within this
[Docket No. FDA–2014–N–1903]
Administration (SBA) revised its size categorical exclusion in the
standard (effective January 22, 2014) for Commission’s regulations. Medical Devices; Physical Medicine
electric utilities from a standard based Devices; Classification of the Powered
on megawatt hours to a standard based VII. Document Availability
Exoskeleton
on the number of employees, including 28. In addition to publishing the full
affiliates.22 Under SBA’s new size text of this document in the Federal AGENCY: Food and Drug Administration,
standards, transmission owners and Register, the Commission provides all HHS.
transmission operators likely come interested persons an opportunity to ACTION: Final order.
under the following category and view and/or print the contents of this
associated size threshold: Electric bulk document via the Internet through the SUMMARY: The Food and Drug
power transmission and control, at 500 Commission’s Home Page (http:// Administration (FDA) is classifying the
employees.23 The Reliability Standard www.ferc.gov) and in the Commission’s powered exoskeleton into class II
applies to 561 entities. Comparison of Public Reference Room during normal (special controls). The special controls
the applicable entities with the business hours (8:30 a.m. to 5:00 p.m. that will apply to the device are
Commission’s small business data Eastern time) at 888 First Street NE., identified in this order and will be part
indicates that approximately 249 are Room 2A, Washington, DC 20426. of the codified language for the powered
small entities.24 Of these, the 29. From the Commission’s Home exoskeleton’s classification. The Agency
Page on the Internet, this information is is classifying the device into class II
21 5 U.S.C. 601–612. available on eLibrary. The full text of (special controls) in order to provide a
22 SBA Final Rule on ‘‘Small Business Size this document is available on eLibrary reasonable assurance of safety and
Standards: Utilities,’’ 78 FR 77,343 (Dec. 23, 2013). in PDF and Microsoft Word format for effectiveness of the device.
23 13 CFR 121.201, Sector 22, Utilities.
24 The Small Business Administration sets the
viewing, printing, and/or downloading. DATES: This order is effective March 26,
threshold for what constitutes a small business. To access this document in eLibrary, 2015. The classification was applicable
Public utilities may fall under one of several type the docket number excluding the on June 26, 2014.
different categories, each with a size threshold last three digits of this document in the FOR FURTHER INFORMATION CONTACT:
tkelley on DSK3SPTVN1PROD with RULES
based on the company’s number of employees, docket number field.
including affiliates, the parent company, and Michael Hoffmann, Center for Devices
subsidiaries. The possible categories for the and Radiological Health, Food and Drug
25 Regulations Implementing the National
applicable entities have a size threshold ranging Administration, 10903 New Hampshire
from 250 employees to 1,000 employees. For the Environmental Policy Act of 1969, Order No. 486,
analysis in this proposed rule, we are using the 52 FR 47897 (Dec. 17, 1987), FERC Stats. & Regs., Ave., Bldg. 66, Rm. 1434, Silver Spring,
1,000 employee threshold for each applicable entity Regulations Preambles 1986–1990 ¶ 30,783 (1987). MD 20993–0002, 301–796–6476,
type. 26 18 CFR 380.4(a)(2)(ii). Michael.Hoffmann@fda.hhs.gov.
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![Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Rules and Regulations 9603
must submit to FDA a premarket § 890.3480 Powered exoskeleton. (ii) Use all safety features of device,
notification, prior to marketing the (a) Identification. A powered and
device, which contains information exoskeleton is a prescription device that (iii) Operate the device in simulated
about the powered exoskeleton they is composed of an external, powered, or actual use environments
intend to market. motorized orthosis used for medical representative of indicated
purposes that is placed over a person’s environments and use.
II. Environmental Impact
paralyzed or weakened limbs for the
The Agency has determined under 21 purpose of providing ambulation. (8) Labeling for the Physician and
CFR 25.34(b) that this action is of a type (b) Classification. Class II (special User must include the following:
that does not individually or controls). The special controls for this (i) Appropriate instructions, warning,
cumulatively have a significant effect on device are: cautions, limitations, and information
the human environment. Therefore, (1) Elements of the device materials related to the necessary safeguards of
neither an environmental assessment that may contact the patient must be the device, including warning against
nor an environmental impact statement demonstrated to be biocompatible. activities and environments that may
is required. (2) Appropriate analysis/testing must
put the user at greater risk.
validate electromagnetic compatibility/
III. Paperwork Reduction Act of 1995 interference (EMC/EMI), electrical (ii) Specific instructions and the
This final order establishes special safety, thermal safety, mechanical clinical training needed for the safe use
controls that refer to previously safety, battery performance and safety, of the device, which includes:
approved collections of information and wireless performance, if applicable. (A) Instructions on assembling the
found in other FDA regulations. These (3) Appropriate software verification, device in all available configurations;
collections of information are subject to validation, and hazard analysis must be
performed. (B) Instructions on fitting the patient;
review by the Office of Management and
Budget (OMB) under the Paperwork (4) Design characteristics must ensure (C) Instructions and explanations of
Reduction Act of 1995 (44 U.S.C. 3501– geometry and materials composition are all available programs and how to
3520). The collections of information in consistent with intended use. program the device;
part 807, subpart E, regarding premarket (5) Non-clinical performance testing
(D) Instructions and explanation of all
notification submissions have been must demonstrate that the device
controls, input, and outputs;
approved under OMB control number performs as intended under anticipated
conditions of use. Performance testing (E) Instructions on all available modes
0910–0120, and the collections of
must include: or states of the device;
information in 21 CFR part 801,
regarding labeling have been approved (i) Mechanical bench testing (F) Instructions on all safety features
under OMB control number 0910–0485. (including durability testing) to of the device; and
demonstrate that the device will
IV. Reference withstand forces, conditions, and (G) Instructions for properly
environments encountered during use; maintaining the device.
The following reference has been
(ii) Simulated use testing (i.e., cyclic (iii) Information on the patient
placed on display in the Division of
loading testing) to demonstrate population for which the device has
Dockets Management (HFA–305), Food
performance of device commands and been demonstrated to have a reasonable
and Drug Administration, 5630 Fishers
safeguard under worst case conditions assurance of safety and effectiveness.
Lane, Rm. 1061, Rockville, MD 20852,
and after durability testing;
and may be seen by interested persons (iv) Pertinent non-clinical testing
(iii) Verification and validation of
between 9 a.m. and 4 p.m., Monday information (e.g., EMC, battery
manual override controls are necessary,
through Friday, and is available longevity).
if present;
electronically at http:// (iv) The accuracy of device features (v) A detailed summary of the clinical
www.regulations.gov. and safeguards; and testing including:
1. K131798: De Novo Request per 513(f)(2) (v) Device functionality in terms of (A) Adverse events encountered
from Argo Medical Technologies, Inc., dated flame retardant materials, liquid/
June 22, 2013. under use conditions,
particle ingress prevention, sensor and
actuator performance, and motor (B) Summary of study outcomes and
List of Subjects in 21 CFR Part 890 endpoints, and
performance.
Medical devices, Physical medicine (6) Clinical testing must demonstrate (C) Information pertinent to use of the
devices. safe and effective use and capture any device including the conditions under
Therefore, under the Federal Food, adverse events observed during clinical which the device was studied (e.g., level
Drug, and Cosmetic Act and under use when used under the proposed of supervision or assistance, and
authority delegated to the Commissioner conditions of use, which must include environment of use (e.g., indoors and/or
of Food and Drugs, 21 CFR part 890 is considerations for: outdoors) including obstacles and
amended as follows: (i) Level of supervision necessary, and terrain).
(ii) Environment of use (e.g., indoors
and/or outdoors) including obstacles Dated: February 18, 2015.
PART 890—PHYSICAL MEDICINE
DEVICES and terrain representative of the Leslie Kux,
intended use environment. Associate Commissioner for Policy.
■ 1. The authority citation for 21 CFR (7) A training program must be
tkelley on DSK3SPTVN1PROD with RULES
[FR Doc. 2015–03692 Filed 2–23–15; 8:45 am]
part 890 continues to read as follows: included with sufficient educational
BILLING CODE 4164–01–P
elements so that upon completion of
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
training program, the clinician, user,
and companion can:
■ 2. Add § 890.3480 to subpart D to read (i) Identify the safe environments for
as follows: device use,
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Document Created: 2015-12-18 13:22:25
Document Modified: 2015-12-18 13:22:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective March 26, 2015. The classification was applicable on June 26, 2014. | |
| Contact | Michael Hoffmann, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1434, Silver Spring, MD 20993-0002, 301- 796-6476, [email protected] | |
| FR Citation | 80 FR 9600 | |
| CFR Associated | Medical Devices and Physical Medicine Devices |
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