80 FR 16266 - Medical Devices; Neurological Devices; Classification of the Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 59 (March 27, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 59 (March 27, 2015)
| Page Range | 16266-16269 | |
| FR Document | 2015-07010 |
[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)] [Rules and Regulations] [Pages 16266-16269] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07010] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 [Docket No. FDA-2015-N-0802] Medical Devices; Neurological Devices; Classification of the Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the brain injury adjunctive interpretive electroencephalograph assessment aid 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 brain injury adjunctive interpretive electroencephalograph assessment aid'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 27, 2015. The classification was applicable on November 17, 2014. FOR FURTHER INFORMATION CONTACT: Jay Gupta, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G312, Silver Spring, MD 20993-0002, 301-796-2795, jay.gupta@fda.hhs.gov. 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 (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) of the FD&C Act, the person requests a classification [[Page 16267]] 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 August 20, 2014, BrainScope Company, Inc., submitted a request for classification of the BrainScope Ahead 100, Models CV-100 and M-100 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 November 17, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding Sec. 882.1450. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a brain injury adjunctive interpretive electroencephalograph assessment aid will need to comply with the special controls named in this final order. The device is assigned the generic name brain injury adjunctive interpretive electroencephalograph assessment aid, and it is identified as a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis. 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--Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation measure ------------------------------------------------------------------------ Adverse tissue reaction................ Biocompatibility. Labeling. Equipment malfunction leading to injury Electrical safety, thermal, and to user/patient (shock, burn, or mechanical testing. mechanical failure). Electromagnetic compatibility testing. Labeling. Delay in treatment or unnecessary Performance testing. treatment due to hardware or software Hardware and software failure. verification, validation and hazard analysis. Electromagnetic compatibility testing. Technical parameters Labeling. False result due to incorrect artifact Software verification and reduction. validation. Labeling. False result due to incorrect placement Clinical performance testing. of electrodes. Labeling. False result when a brain injury Clinical performance testing. adjunctive interpretive EEG assessment Device design characteristics. aid impacts the clinical decision. Labeling. Use error.............................. Clinical performance testing. 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:The technical parameters of the device, hardware and software, must be fully characterized and include the following information: [cir] Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed. [cir] Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed. The device parts that contact the patient must be demonstrated to be biocompatible. The device must be designed and tested for electrical safety, electromagnetic compatibility (EMC), thermal, and mechanical safety. Clinical performance testing must demonstrate the accuracy, precision-repeatability and reproducibility, of determining the EEG-based [[Page 16268]] interpretation, including any specified equivocal zones (cut-offs). Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with respect to the study prevalence per the device intended use. The device design must include safeguards to ensure appropriate clinical interpretation of the device output (e.g., use in appropriate patient population, or for appropriate clinical decision). The labeling and training information must include: [cir] A warning that the device is not to be used as a stand-alone diagnostic. [cir] A detailed summary of the clinical performance testing, including any adverse events and complications. [cir] The intended use population and the intended use environment. [cir] Any instructions technicians should convey to patients regarding the collection of EEG data. [cir] Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway. [cir] Information allowing clinicians to understand how to integrate the device output into their diagnostic pathway when the device is unable to provide a classification or final result. Brain injury adjunctive interpretive electroencephalograph assessment aid devices are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; see 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 must submit to FDA a premarket notification, prior to marketing the device, which contains information about the brain injury adjunctive interpretive electroencephalograph assessment aid 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 21 CFR 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. [DEN140025]: De Novo Request per 513(f)(2) from BrainScope Company, Inc., dated August 20, 2014. List of Subjects in 21 CFR Part 882 Medical devices, Neurological devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows: PART 882--NEUROLOGICAL DEVICES 0 1. The authority citation for 21 CFR part 882 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 0 2. Add Sec. 882.1450 to subpart B to read as follows: Sec. 882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid. (a) Identification. A brain injury adjunctive interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis. (b) Classification. Class II (special controls). The special controls for this device are: (1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information: (i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed. (ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed. (2) The device parts that contact the patient must be demonstrated to be biocompatible. (3) The device must be designed and tested for electrical safety, electromagnetic compatibility (EMC), thermal, and mechanical safety. (4) Clinical performance testing must demonstrate the accuracy, precision-repeatability and reproducibility, of determining the EEG- based interpretation, including any specified equivocal zones (cutoffs). (5) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with respect to the study prevalence per the device intended use. (6) The device design must include safeguards to ensure appropriate clinical interpretation of the device output (e.g., [[Page 16269]] use in appropriate patient population, or for appropriate clinical decision). (7) The labeling and training information must include: (i) A warning that the device is not to be used as a stand-alone diagnostic. (ii) A detailed summary of the clinical performance testing, including any adverse events and complications. (iii) The intended use population and the intended use environment. (iv) Any instructions technicians should convey to patients regarding the collection of EEG data. (v) Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway. (vi) Information allowing clinicians to understand how to integrate the device output into their diagnostic pathway when the device is unable to provide a classification or final result. Dated: March 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-07010 Filed 3-26-15; 8:45 am] BILLING CODE 4164-01-P
![16268 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations
interpretation, including any specified intend to market this type of device § 882.1450 Brain injury adjunctive
equivocal zones (cut-offs). must submit to FDA a premarket interpretive electroencephalograph
• Clinical performance testing must notification, prior to marketing the assessment aid.
demonstrate the ability of the device to device, which contains information (a) Identification. A brain injury
function as an assessment aid for the about the brain injury adjunctive adjunctive interpretive
medical condition for which the device interpretive electroencephalograph electroencephalograph assessment aid is
is indicated. Performance measures assessment aid they intend to market. a prescription device that uses a
must demonstrate device performance patient’s electroencephalograph (EEG)
characteristics per the intended use in II. Environmental Impact to provide an interpretation of the
the intended use environment. The Agency has determined under 21 structural condition of the patient’s
Performance measurements must CFR 25.34(b) that this action is of a type brain in the setting of trauma. A brain
include sensitivity, specificity, positive that does not individually or injury adjunctive interpretive EEG
predictive value (PPV), and negative cumulatively have a significant effect on assessment aid is for use as an adjunct
predictive value (NPV) with respect to the human environment. Therefore, to standard clinical practice only as an
the study prevalence per the device neither an environmental assessment assessment aid for a medical condition
intended use. nor an environmental impact statement for which there exists other valid
• The device design must include is required. methods of diagnosis.
safeguards to ensure appropriate clinical (b) Classification. Class II (special
interpretation of the device output (e.g., III. Paperwork Reduction Act of 1995
controls). The special controls for this
use in appropriate patient population, This final order establishes special device are:
or for appropriate clinical decision). controls that refer to previously (1) The technical parameters of the
• The labeling and training approved collections of information device, hardware and software, must be
information must include: found in other FDA regulations. These fully characterized and include the
Æ A warning that the device is not to collections of information are subject to following information:
be used as a stand-alone diagnostic. review by the Office of Management and (i) Hardware specifications must be
Æ A detailed summary of the clinical Budget (OMB) under the Paperwork provided. Appropriate verification,
performance testing, including any Reduction Act of 1995 (44 U.S.C. 3501– validation, and hazard analysis must be
adverse events and complications. 3520). The collections of information in performed.
Æ The intended use population and 21 CFR part 807, subpart E, regarding (ii) Software, including any
the intended use environment. premarket notification submissions have
Æ Any instructions technicians proprietary algorithm(s) used by the
been approved under OMB control device to arrive at its interpretation of
should convey to patients regarding the number 0910–0120, and the collections
collection of EEG data. the patient’s condition, must be
of information in 21 CFR part 801, described in detail in the software
Æ Information allowing clinicians to regarding labeling have been approved
gauge clinical risk associated with requirements specification (SRS) and
under OMB control number 0910–0485. software design specification (SDS).
integrating the EEG interpretive
assessment aid into their diagnostic IV. Reference Appropriate software verification,
pathway. validation, and hazard analysis must be
The following reference has been performed.
Æ Information allowing clinicians to placed on display in the Division of
understand how to integrate the device (2) The device parts that contact the
Dockets Management (HFA–305), Food patient must be demonstrated to be
output into their diagnostic pathway and Drug Administration, 5630 Fishers
when the device is unable to provide a biocompatible.
Lane, Rm. 1061, Rockville, MD 20852, (3) The device must be designed and
classification or final result. and may be seen by interested persons
Brain injury adjunctive interpretive tested for electrical safety,
between 9 a.m. and 4 p.m., Monday electromagnetic compatibility (EMC),
electroencephalograph assessment aid
through Friday, and is available thermal, and mechanical safety.
devices are prescription devices
electronically at http:// (4) Clinical performance testing must
restricted to patient use only upon the
www.regulations.gov. demonstrate the accuracy, precision-
authorization of a practitioner licensed
by law to administer or use the device; 1. [DEN140025]: De Novo Request per repeatability and reproducibility, of
see 21 CFR 801.109 (Prescription 513(f)(2) from BrainScope Company, Inc., determining the EEG-based
dated August 20, 2014. interpretation, including any specified
devices)). Prescription-use restrictions
are a type of general controls as defined List of Subjects in 21 CFR Part 882 equivocal zones (cutoffs).
in section 513(a)(1)(A)(i) of the FD&C (5) Clinical performance testing must
Medical devices, Neurological demonstrate the ability of the device to
Act.
Section 510(m) of the FD&C Act devices. function as an assessment aid for the
provides that FDA may exempt a class Therefore, under the Federal Food, medical condition for which the device
II device from the premarket notification Drug, and Cosmetic Act and under is indicated. Performance measures
requirements under section 510(k) of the authority delegated to the Commissioner must demonstrate device performance
FD&C Act, if FDA determines that of Food and Drugs, 21 CFR part 882 is characteristics per the intended use in
premarket notification is not necessary amended as follows: the intended use environment.
to provide reasonable assurance of the Performance measurements must
PART 882—NEUROLOGICAL DEVICES
asabaliauskas on DSK5VPTVN1PROD with RULES
safety and effectiveness of the device. include sensitivity, specificity, positive
For this type of device, FDA has ■ 1. The authority citation for 21 CFR predictive value (PPV), and negative
determined that premarket notification part 882 continues to read as follows: predictive value (NPV) with respect to
is necessary to provide reasonable the study prevalence per the device
assurance of the safety and effectiveness Authority: 21 U.S.C. 351, 360, 360c, 360e, intended use.
360j, 371.
of the device. Therefore, this device (6) The device design must include
type is not exempt from premarket ■ 2. Add § 882.1450 to subpart B to read safeguards to ensure appropriate clinical
notification requirements. Persons who as follows: interpretation of the device output (e.g.,
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![Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations 16269
use in appropriate patient population, and to select those who are the most to ensure that those who are enlisted,
or for appropriate clinical decision). trainable and adaptable to Service life. appointed, or inducted are the best
(7) The labeling and training DATES: Effective Date: This rule is qualified to complete their prescribed
information must include: effective March 27, 2015. Comments training and the best able to adapt to the
(i) A warning that the device is not to must be received by May 26, 2015. military life. Failure to maintain these
be used as a stand-alone diagnostic. ADDRESSES: You may submit comments, standards would result in a high
(ii) A detailed summary of the clinical identified by docket number and or attrition of personnel and would
performance testing, including any Regulatory Information Number (RIN) significantly increase training costs. The
adverse events and complications. and title, by any of the following success of today’s All-volunteer military
(iii) The intended use population and methods: is dependent on this policy.
the intended use environment. • Federal Rulemaking Portal: http://
(iv) Any instructions technicians www.regulations.gov. Follow the Justification for Interim Final Rule
should convey to patients regarding the instructions for submitting comments. This rule is being published as an
collection of EEG data. • Mail: Federal Docket Management
(v) Information allowing clinicians to interim final rule to provide required
System Office, 4800 Mark Center Drive,
gauge clinical risk associated with updates in DoD policy and procedures
2nd Floor, East Tower, Suite 02G09,
integrating the EEG interpretive Alexandria, VA 22350–3100. that impact the public. It has been
assessment aid into their diagnostic Instructions: All submissions received almost 10 years since these policies and
pathway. must include the agency name and procedures have been updated. Some
(vi) Information allowing clinicians to docket number or RIN for this Federal policy changes and court decisions have
understand how to integrate the device Register document. The general policy a great impact on the eligibility of
output into their diagnostic pathway for comments and other submissions potential applicants entry into the
when the device is unable to provide a from members of the public is to make military. All language addressing
classification or final result. these submissions available for public homosexual conduct has been removed
Dated: March 23, 2015. viewing on the Internet at http:// in accordance with the December 22,
www.regulations.gov as they are 2010, repeal of the Don’t Ask Don’t Tell
Leslie Kux,
received without change, including any policy, which opened military service to
Associate Commissioner for Policy.
personal identifiers or contact homosexuals, and the subsequent
[FR Doc. 2015–07010 Filed 3–26–15; 8:45 am]
information. United States vs. Windsor decision (570
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT: U.S. 12, 133 S. Ct 2675 (2013)) which
Dennis J. Drogo, (703) 697–9268. found section 3 of the Defense of
SUPPLEMENTARY INFORMATION: Marriage Act (DOMA) unconstitutional.
DEPARTMENT OF DEFENSE By removing all references to
Executive Summary homosexuality, otherwise qualified
Office of the Secretary
I. Purpose of This Regulatory Action applicants are now free to apply and
enroll in a military academy without
32 CFR Part 66 This rule updates policies and
prejudice or fear of reprisal. This
responsibilities for basic entrance
[Docket ID: DOD–2011–OS–0099] interim rule is required immediately to
qualification standards for enlistment,
appointment, and induction into the remove any legal and policy restrictions
RIN 0790–AI78
Armed Forces and delegates the which would prevent a potential
Qualification Standards for Enlistment, authority to specify certain standards to applicant from entry into a military
Appointment, and Induction the Secretaries of the Military based solely on their sexual orientation.
Departments. It is important for DoD to have current
AGENCY: Office of the Under Secretary of
and up-to-date enlistment, appointment,
Defense for Personnel and Readiness, II. Summary of the Major Provisions of
and induction standards, which are
DoD. This Regulatory Action
essential in defining the measures
ACTION: Interim final rule. (a) Establishes age, aptitude, necessary to evaluate and qualify
character/conduct, citizenship, civilians for military service. A critical
SUMMARY: This rule updates policies and dependents, education, medical,
responsibilities for basic entrance component of this update is the
physical fitness, and other disqualifying clarification of one of the underlying
qualification standards for enlistment, conditions that are causes for rejection
appointment, and induction into the purposes of the enlistment,
from military service. Other standards appointment, and induction standards
Armed Forces and delegates the may be prescribed in the event of
authority to specify certain standards to which is to minimize entrance of
mobilization or national emergency. persons who are likely to become
the Secretaries of the Military (b) Sets standards designed to ensure
Departments. It establishes the age, disciplinary cases, security risks, or who
that individuals under consideration for
aptitude, character/conduct, citizenship, are likely to disrupt good order, morale,
enlistment, appointment, and/or
dependents, education, medical, and discipline. The Military Services
induction are able to perform military
physical fitness, and other disqualifying are responsible for the defense of the
duties successfully and to select those
conditions that are causes for rejection who are the most trainable and Nation and should not be viewed as a
asabaliauskas on DSK5VPTVN1PROD with RULES
from military service. Other standards adaptable to Service life. source of rehabilitation for those who
may be prescribed in the event of (c) Removes provisions related to have not subscribed to the legal and
mobilization or national emergency. homosexual conduct. moral standards of society at-large. The
This rule sets standards designed to necessity of publishing these current
ensure that individuals under III. Costs and Benefits of This standards, as an interim final rule, is
consideration for enlistment, Regulatory Action vital to the DoD meeting its mission to
appointment, and/or induction are able The benefit of publishing this interim man the All Volunteer Force with
to perform military duties successfully, final rule is that it establishes standards qualified citizens.
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Document Created: 2015-12-18 11:36:16
Document Modified: 2015-12-18 11:36:16
| 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 27, 2015. The classification was applicable on November 17, 2014. | |
| Contact | Jay Gupta, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G312, Silver Spring, MD 20993-0002, 301-796-2795, [email protected] | |
| FR Citation | 80 FR 16266 | |
| CFR Associated | Medical Devices and Neurological Devices |
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