81 FR 71610 - Medical Devices; Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 201 (October 18, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 201 (October 18, 2016)
| Page Range | 71610-71612 | |
| FR Document | 2016-25001 |
[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)] [Rules and Regulations] [Pages 71610-71612] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25001] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 890 [Docket No. FDA-2016-N-2829] Medical Devices; Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components 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 upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components' 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 October 18, 2016. The classification was applicable on May 9, 2014. FOR FURTHER INFORMATION CONTACT: Michael Hoffmann, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2640, Silver Spring, MD, 20993-0002, 301- 796-6476, [email protected]. 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), 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 (Pub. L. 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), the person requests a classification under section 513(f)(2) of the FD&C Act. Under the second procedure, rather than first submitting a premarket notification under section 510(k) 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 shall classify the device by written order within 120 days. This classification will be the initial classification of the device. In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on May 18, 2012, classifying the DEKA Arm System into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On June 15, 2012, DEKA Integrated Solutions Corporation submitted a request for classification of the DEKA Arm System under section 513(f)(2) of the FD&C Act. 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 May 9, 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 890.3450. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for an upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components will need to comply with the special controls named in this final order. The device is assigned the generic name upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components, and it is identified as a prescription device intended for medical purposes, and intended to replace a partially or fully amputated or congenitally absent upper extremity. It uses electronic inputs (other than simple, manually controlled electrical components such as switches) to provide greater than two independent and simultaneously powered degrees of freedom and includes a simultaneously [[Page 71611]] powered elbow and/or shoulder. Prosthetic arm components that are intended to be used as a system with other arm components must include all degrees of freedom of the total upper extremity prosthesis system. FDA has identified the following risks to health associated specifically with this type of device, as well as the mitigation measures required to mitigate these risks in table 1. Table 1--Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components Risks and Mitigation Measures ---------------------------------------------------------------------------------------------------------------- Identified risk Mitigation measures ---------------------------------------------------------------------------------------------------------------- Unintended Motion................................. Electronic Input Testing. Software Verification, Validation, and Hazards Analysis. Wireless Testing. Electromagnetic Compatibility (EMC) Testing. Non-clinical Performance Testing. Water/Particle Ingress Testing. Durability Testing. Battery Testing. Labeling. Adverse Tissue Reaction........................... Biocompatibility Assessment. Battery Failure................................... Battery Testing. Water/Particle Ingress Testing. Labeling. Electromagnetic Incompatibility................... EMC testing. Labeling. Electrical Safety Issues (e.g., shock)............ Electrical Safety Testing. Labeling. Gripping Malfunction.............................. Non-clinical Performance Testing. Software Verification, Validation, and Hazards Analysis. Labeling. High Risk Activities (e.g., driving).............. Labeling. Malfunction Due to Environmental Conditions....... Non-clinical Performance Testing. Battery Testing. Water/Particle Ingress Testing. Wireless Testing. EMC Testing. Flammability Testing. Labeling. Use Error......................................... Clinical Studies. Human Factors Studies. Labeling. ---------------------------------------------------------------------------------------------------------------- FDA believes that the special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness. An upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components is not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109, Prescription devices). 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 must submit to FDA a premarket notification, prior to marketing the device, which contains information about the upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non- implanted electrical components they intend to market. II. 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. 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. 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: [[Page 71612]] PART 890--PHYSICAL MEDICINE DEVICES 0 1. The authority citation for part 890 is revised to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 890.3450 to subpart D to read as follows: Sec. 890.3450 Upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components. (a) Identification. A upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components, is a prescription device intended for medical purposes, and is intended to replace a partially or fully amputated or congenitally absent upper extremity. It uses electronic inputs (other than simple, manually controlled electrical components such as switches) to provide greater than two independent and simultaneously powered degrees of freedom and includes a simultaneously powered elbow and/or shoulder. Prosthetic arm components that are intended to be used as a system with other arm components must include all degrees of freedom of the total upper extremity prosthesis system. (b) Classification. Class II (special controls). The special controls for this device are: (1) Appropriate analysis/testing must validate electronic compatibility, electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable. (2) Appropriate software verification, validation, and hazard analysis must be performed. (3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include: (i) Mechanical bench data, including durability testing, to demonstrate that the device will withstand forces, conditions, and environments encountered during use. (ii) Simulated use testing to demonstrate performance of arm commands and available safeguard(s) under worst case conditions and after durability testing. (iii) Verification and validation of force sensors and hand release button, if applicable, are necessary. (iv) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor and brake performance. (v) The accuracy of the device features and safeguards. (4) Non-clinical and clinical performance testing must demonstrate the accuracy of device features and safeguards. (5) Elements of the device that may contact the patient must be demonstrated to be biocompatible. (6) Documented clinical experience and human factors testing must demonstrate safe and effective use, capture any adverse events observed during clinical use and demonstrate the accuracy of device features and safeguards. (7) Labeling for the Prosthetist and User Guide must include: (i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities that may put the user at greater risk (e.g., driving). (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 maintaining the device. (iii) Information on the patient population for which the device has been demonstrated to be effective. (iv) A detailed summary of the non-clinical and clinical testing pertinent to use of the device. Dated: October 11, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-25001 Filed 10-17-16; 8:45 am] BILLING CODE 4164-01-P
![71610 Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Rules and Regulations
information. Absent that, I will have no basis commercial distribution before May 28, FD&C Act, FDA issued an order on May
from which to change the phase-in or move 1976 (the date of enactment of the 18, 2012, classifying the DEKA Arm
the threshold to something other than $3 Medical Device Amendments of 1976), System into class III, because it was not
billion. generally referred to as postamendments substantially equivalent to a device that
[FR Doc. 2016–25143 Filed 10–17–16; 8:45 am]
devices, are classified automatically by was introduced or delivered for
BILLING CODE 6351–01–P
statute into class III without any FDA introduction into interstate commerce
rulemaking process. These devices for commercial distribution before May
remain in class III and require 28, 1976, or a device which was
DEPARTMENT OF HEALTH AND premarket approval, unless and until subsequently reclassified into class I or
HUMAN SERVICES the device is classified or reclassified class II.
into class I or II, or FDA issues an order On June 15, 2012, DEKA Integrated
Food and Drug Administration finding the device to be substantially Solutions Corporation submitted a
equivalent, in accordance with section request for classification of the DEKA
21 CFR Part 890 513(i), to a predicate device that does Arm System under section 513(f)(2) of
[Docket No. FDA–2016–N–2829] not require premarket approval. The the FD&C Act. In accordance with
Agency determines whether new section 513(f)(2) of the FD&C Act, FDA
Medical Devices; Physical Medicine devices are substantially equivalent to reviewed the request in order to classify
Devices; Classification of the Upper predicate devices by means of the device under the criteria for
Extremity Prosthesis Including a premarket notification procedures in classification set forth in section
Simultaneously Powered Elbow and/or section 510(k) of the FD&C Act (21 513(a)(1). FDA classifies devices into
Shoulder With Greater Than Two U.S.C. 360(k)) and part 807 (21 CFR part class II if general controls by themselves
Simultaneous Powered Degrees of 807) of the regulations. are insufficient to provide reasonable
Freedom and Controlled by Non- Section 513(f)(2) of the FD&C Act, as assurance of safety and effectiveness,
Implanted Electrical Components amended by section 607 of the Food and but there is sufficient information to
Drug Administration Safety and establish special controls to provide
AGENCY: Food and Drug Administration, Innovation Act (Pub. L. 112–144), reasonable assurance of the safety and
HHS. provides two procedures by which a effectiveness of the device for its
ACTION: Final order. person may request FDA to classify a intended use. After review of the
SUMMARY: The Food and Drug device under the criteria set forth in information submitted in the request,
Administration (FDA) is classifying the section 513(a)(1). Under the first FDA determined that the device can be
Upper Extremity Prosthesis Including a procedure, the person submits a classified into class II with the
Simultaneously Powered Elbow and/or premarket notification under section establishment of special controls. FDA
Shoulder with Greater Than Two 510(k) of the FD&C Act for a device that believes these special controls, in
Simultaneous Powered Degrees of has not previously been classified and, addition to general controls, will
Freedom and Controlled by Non- within 30 days of receiving an order provide reasonable assurance of the
Implanted Electrical Components into classifying the device into class III safety and effectiveness of the device.
under section 513(f)(1), the person Therefore, on May 9, 2014, FDA
class II (special controls). The special
requests a classification under section issued an order to the requestor
controls that will apply to the device are
513(f)(2) of the FD&C Act. Under the classifying the device into class II. FDA
identified in this order and will be part is codifying the classification of the
second procedure, rather than first
of the codified language for the upper device by adding 21 CFR 890.3450.
submitting a premarket notification
extremity prosthesis including a Following the effective date of this
under section 510(k) and then a request
simultaneously powered elbow and/or final classification order, any firm
for classification under the first
shoulder with greater than two submitting a premarket notification
procedure, the person determines that
simultaneous powered degrees of (510(k)) for an upper extremity
there is no legally marketed device upon
freedom and controlled by non- prosthesis including a simultaneously
which to base a determination of
implanted electrical components’ powered elbow and/or shoulder with
substantial equivalence and requests a
classification. The Agency is classifying classification under section 513(f)(2) of greater than two simultaneous powered
the device into class II (special controls) the FD&C Act. If the person submits a degrees of freedom and controlled by
in order to provide a reasonable request to classify the device under this non-implanted electrical components
assurance of safety and effectiveness of second procedure, FDA may decline to will need to comply with the special
the device. undertake the classification request if controls named in this final order. The
DATES: This order is effective October FDA identifies a legally marketed device device is assigned the generic name
18, 2016. The classification was that could provide a reasonable basis for upper extremity prosthesis including a
applicable on May 9, 2014. review of substantial equivalence with simultaneously powered elbow and/or
FOR FURTHER INFORMATION CONTACT: the device or if FDA determines that the shoulder with greater than two
Michael Hoffmann, Center for Devices device submitted is not of ‘‘low- simultaneous powered degrees of
and Radiological Health, Food and Drug moderate risk’’ or that general controls freedom and controlled by non-
Administration, 10903 New Hampshire would be inadequate to control the risks implanted electrical components, and it
Ave., Bldg. 66, Rm. 2640, Silver Spring, and special controls to mitigate the risks is identified as a prescription device
MD, 20993–0002, 301–796–6476, cannot be developed. intended for medical purposes, and
Michael.Hoffmann@fda.hhs.gov. In response to a request to classify a intended to replace a partially or fully
SUPPLEMENTARY INFORMATION: device under either procedure provided amputated or congenitally absent upper
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by section 513(f)(2) of the FD&C Act, extremity. It uses electronic inputs
I. Background FDA shall classify the device by written (other than simple, manually controlled
In accordance with section 513(f)(1) of order within 120 days. This electrical components such as switches)
the Federal Food, Drug, and Cosmetic classification will be the initial to provide greater than two independent
Act (the FD&C Act) (21 U.S.C. classification of the device. In and simultaneously powered degrees of
360c(f)(1)), devices that were not in accordance with section 513(f)(1) of the freedom and includes a simultaneously
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PART 890—PHYSICAL MEDICINE particle ingress prevention, sensor and DEPARTMENT OF HOMELAND
DEVICES actuator performance, and motor and SECURITY
brake performance.
■ 1. The authority citation for part 890 Coast Guard
is revised to read as follows: (v) The accuracy of the device features
and safeguards.
Authority: 21 U.S.C. 351, 360, 360c, 360e, 33 CFR Part 117
360j, 360l, 371. (4) Non-clinical and clinical
[Docket No. USCG–2016–0610]
■ 2. Add § 890.3450 to subpart D to read performance testing must demonstrate
as follows: the accuracy of device features and Drawbridge Operation Regulation;
safeguards. Atlantic Intracoastal Waterway (AIWW),
§ 890.3450 Upper extremity prosthesis
including a simultaneously powered elbow (5) Elements of the device that may Wrightsville Beach, NC and Northeast
and/or shoulder with greater than two contact the patient must be Cape Fear River, Wilmington, NC
simultaneous powered degrees of freedom demonstrated to be biocompatible. AGENCY: Coast Guard, DHS.
and controlled by non-implanted electrical (6) Documented clinical experience
components. ACTION:Notice of deviation from
and human factors testing must drawbridge regulation.
(a) Identification. A upper extremity
demonstrate safe and effective use,
prosthesis including a simultaneously SUMMARY: The Coast Guard has issued a
capture any adverse events observed
powered elbow and/or shoulder with temporary deviation from the operating
greater than two simultaneous powered during clinical use and demonstrate the
accuracy of device features and schedules that govern the S.R. 74
degrees of freedom and controlled by (Wrightsville Beach) Bridge across the
non-implanted electrical components, is safeguards.
Atlantic Intracoastal Waterway (AIWW),
a prescription device intended for (7) Labeling for the Prosthetist and mile 283.1, at Wrightsville Beach, NC
medical purposes, and is intended to User Guide must include: and the Isabel S. Holmes Bridge across
replace a partially or fully amputated or (i) Appropriate instructions, warning, the Northeast Cape Fear River, mile 1.0,
congenitally absent upper extremity. It cautions, limitations, and information at Wilmington, NC. The deviation is
uses electronic inputs (other than necessary to facilitate the 2016 PPD
related to the necessary safeguards of
simple, manually controlled electrical IRONMAN North Carolina
the device, including warning against
components such as switches) to ‘‘Beach2Battleship’’ Triathlon. This
provide greater than two independent activities that may put the user at
greater risk (e.g., driving). deviation allows these bridges to remain
and simultaneously powered degrees of
in their closed-to-navigation position.
freedom and includes a simultaneously (ii) Specific instructions and the
powered elbow and/or shoulder. clinical training needed for the safe use DATES: The deviation is effective from
Prosthetic arm components that are of the device, which includes: 6:30 a.m. to 6 p.m. on October 22, 2016.
intended to be used as a system with ADDRESSES: The docket for this
(A) Instructions on assembling the deviation, [USCG–2016–0610] is
other arm components must include all
device in all available configurations, available at http://www.regulations.gov.
degrees of freedom of the total upper
extremity prosthesis system. (B) Instructions on fitting the patient, Type the docket number in the
(b) Classification. Class II (special (C) Instructions and explanations of ‘‘SEARCH’’ box and click ‘‘SEARCH’’.
controls). The special controls for this all available programs and how to Click on Open Docket Folder on the line
device are: program the device, associated with this deviation.
(1) Appropriate analysis/testing must FOR FURTHER INFORMATION CONTACT: If
validate electronic compatibility, (D) Instructions and explanation of all
you have questions on this temporary
electrical safety, thermal safety, controls, input, and outputs,
deviation, call or email Mr. Michael
mechanical safety, battery performance (E) Instructions on all available modes Thorogood, Bridge Administration
and safety, and wireless performance, if or states of the device, Branch Fifth District, Coast Guard,
applicable. telephone 757–398–6557, email
(2) Appropriate software verification, (F) Instructions on all safety features
of the device, and Michael.R.Thorogood@uscg.mil.
validation, and hazard analysis must be
SUPPLEMENTARY INFORMATION: PPD
performed. (G) Instructions for maintaining the
(3) Non-clinical performance data device. Ironman North Carolina, on behalf of
must demonstrate that the device the North Carolina Department of
(iii) Information on the patient Transportation, who owns the S.R. 74
performs as intended under anticipated population for which the device has
conditions of use. Performance testing (Wrightsville Beach) Bridge across the
been demonstrated to be effective. Atlantic Intracoastal Waterway (AIWW),
must include:
(i) Mechanical bench data, including (iv) A detailed summary of the non- mile 283.1, at Wrightsville Beach, NC
durability testing, to demonstrate that clinical and clinical testing pertinent to and the Isabel S. Holmes Bridge across
the device will withstand forces, use of the device. the Northeast Cape Fear River, mile 1.0,
conditions, and environments at Wilmington, NC, has requested a
Dated: October 11, 2016.
encountered during use. temporary deviation from the current
(ii) Simulated use testing to Leslie Kux, operating regulations set out in 33 CFR
demonstrate performance of arm Associate Commissioner for Policy. 117.821(a)(4) and 33 CFR 117.829(a),
commands and available safeguard(s) [FR Doc. 2016–25001 Filed 10–17–16; 8:45 am] respectively, to ensure the safety of the
under worst case conditions and after BILLING CODE 4164–01–P participants and spectators associated
Lhorne on DSK30JT082PROD with RULES
durability testing. with the 2016 PPD IRONMAN North
(iii) Verification and validation of Carolina ‘‘Beach2Battleship’’ Triathlon.
force sensors and hand release button, if Under this temporary deviation, the
applicable, are necessary. S.R. 74 (Wrightsville Beach) Bridge will
(iv) Device functionality in terms of be maintained in the closed-to-
flame retardant materials, liquid/ navigation position from 6:30 a.m. to 11
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Document Created: 2016-10-17 23:52:41
Document Modified: 2016-10-17 23:52:41
| 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 October 18, 2016. The classification was applicable on May 9, 2014. | |
| Contact | Michael Hoffmann, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2640, Silver Spring, MD, 20993-0002, 301- 796-6476, [email protected] | |
| FR Citation | 81 FR 71610 |
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