83 FR 27699 - Medical Devices; Immunology and Microbiology Devices; Classification of the Brain Trauma Assessment Test
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 115 (June 14, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 115 (June 14, 2018)
| Page Range | 27699-27702 | |
| FR Document | 2018-12760 |
[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)] [Rules and Regulations] [Pages 27699-27702] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12760] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2018-N-1928] Medical Devices; Immunology and Microbiology Devices; Classification of the Brain Trauma Assessment Test AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the brain trauma assessment test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the brain trauma assessment test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. DATES: This order is effective June 14, 2018. The classification was applicable on February 14, 2018. FOR FURTHER INFORMATION CONTACT: Erin Cutts, Center for Devices and Radiological Health, Food and Drug [[Page 27700]] Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5618, Silver Spring, MD 20993-0002, 301-796-6307, erin.cutts@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the brain trauma assessment test as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment. The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as ``postamendments devices'' because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807). FDA may also classify a device through ``De Novo'' classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification. Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act. Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device. We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining ``substantial equivalence''). Instead, sponsors can use the less burdensome 510(k) process, when necessary, to market their device. II. De Novo Classification On August 28, 2017, Banyan Biomarkers, Inc., submitted a request for De Novo classification of the Banyan BTI. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on February 14, 2018, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.5830. We have named the generic type of device brain trauma assessment test, and it is identified as a device that consists of reagents used to detect and measure brain injury biomarkers in human specimens. The measurements aid in the evaluation of patients with suspected mild traumatic brain injury in conjunction with other clinical information to assist in determining the need for head imaging per current standard of care. FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1. Table 1--Brain Trauma Assessment Test Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Inaccurate test results that provide General controls and special false positive or false negative control (1) (21 CFR results. 866.5830(b)(1)). Failure to correctly interpret test General controls and special results can lead to false positive or control (2) (21 CFR false negative results. 866.5830(b)(2)). ------------------------------------------------------------------------ FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to [[Page 27701]] premarket notification requirements under section 510(k) of the FD&C Act. III. Analysis of Environmental Impact The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. IV. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document ``De Novo Classification Process (Evaluation of Automatic Class III Designation)'' have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910- 0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 866 Biologics, Laboratories, 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 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 0 1. The authority citation for part 866 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 866.5830 to subpart F to read as follows: Sec. 866.5830 Brain trauma assessment test. (a) Identification. A brain trauma assessment test is a device that consists of reagents used to detect and measure brain injury biomarkers in human specimens. The measurements aid in the evaluation of patients with suspected mild traumatic brain injury in conjunction with other clinical information to assist in determining the need for head imaging per current standard of care. (b) Classification. Class II (special controls). The special controls for this device are: (1) The 21 CFR 809.10(b) compliant labeling must include detailed descriptions of and results from performance testing conducted to evaluate precision, accuracy, linearity, analytical sensitivity, interference, and cross-reactivity. This information must include the following: (i) Performance testing of device precision must, at minimum, use one unmodified clinical specimen from the intended use population with concentration of the brain injury biomarker(s) near the medical decision point. Contrived specimens that have been generated from pooling of multiple samples or spiking of purified analyte to cover the measuring range may be used, but the contrived samples must be prepared to mimic clinical specimens as closely as possible. This testing must evaluate repeatability and reproducibility using a protocol from an FDA-recognized standard. (ii) Device performance data must be demonstrated through a clinical study and must include the following: (A) Data demonstrating clinical validity including the clinical sensitivity and specificity, and positive and negative predictive value of the test in the intended use population of patients with suspected mild traumatic brain injury (i.e., Glasgow Coma Score (GCS) of 13-15), or equivalent standard of care for determination of severity of traumatic brain injury (TBI). (B) Study must be performed using the operators and in settings that are representative of the types of operators and settings for which the device is intended to be used. (C) All eligible subjects must meet the well-defined study inclusion and exclusion criteria that define the intended use population. The prevalence of diseased or injured subjects in the study population must reflect the prevalence of the device's intended use population, or alternatively, statistical measures must be used to account for any bias due to enrichment of subpopulations of the intended use population. (D) All eligible subjects must have undergone a head computerized tomography (CT) scan or other appropriate clinical diagnostic standard used to determine the presence of an intracranial lesion as part of standard of care and must also be evaluated by the subject device. All clinical diagnostic standards used in the clinical study must follow standard clinical practice in the United States. (E) Relevant demographic variables and baseline characteristics including medical history and neurological history. In addition, head injury characteristics, neurological assessments, and physical evidence of trauma must be provided for each subject. This information includes but is not limited to the following: Time since head injury, time from head injury to CT scan, time from head injury to blood draw, GCS score or equivalent, experience of loss of consciousness, presence of confusion, episodes of vomiting, post-traumatic amnesia characteristics, presence of post-traumatic seizures, drug or alcohol intoxication, mechanism of injury, acute intracranial lesion type, neurosurgical lesion, and cranial fracture. (F) Each CT scan or other imaging result must be independently evaluated in a blinded manner by at least two board-certified radiologists to determine whether it is positive or negative as defined by the presence or absence of acute intracranial lesions. This independent review must be conducted without access to test results of the device. Prior to conducting the review, the criteria and procedures to be followed for scoring the images must be established, including the mechanism for determining consensus. (G) All the clinical samples must be tested with the subject device blinded to the TBI status and the neurological-lesion-status of the subject. (H) Details on how missing values in data are handled must be provided. (I) For banked clinical samples, details on storage conditions and storage period must be provided. In addition, a specimen stability study must be conducted for the duration of storage to demonstrate integrity of archived clinical samples. The samples evaluated in the assay test development must not be used to establish the clinical validity of the assays. (iii) Performance testing of device analytical specificity must include the most commonly reported concomitant medications present in specimens from the intended use population. Additionally, potential cross-reacting endogenous analytes must be evaluated at the highest concentration reported in specimens from the intended use population. (iv) Expected/reference values generated by testing a statistically appropriate number of samples from apparently healthy normal individuals. [[Page 27702]] (2) The 21 CFR 809.10(a) and (b) compliant labeling must include the following limitations: (i) A limiting statement that this device is not intended to be used a stand-alone device but as an adjunct to other clinical information to aid in the evaluation of patients who are being considered for standard of care neuroimaging. (ii) A limiting statement that reads ``A negative result is generally associated with the absence of acute intracranial lesions. An appropriate neuroimaging method is required for diagnosis of acute intracranial lesions.'' (iii) As applicable, a limiting statement that reads ``This device is for use by laboratory professionals in a clinical laboratory setting.'' Dated: June 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12760 Filed 6-13-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 27699
including the limitation imposed on the § 725.717 What are the time limitations for may be achieved through a program of
amount to be paid. requesting payment or reimbursement for re-evaluation and redirection of the
covered medical services or treatments? miner’s abilities, or retraining in another
§ 725.716 How should a miner prepare and OWCP will pay providers and occupation, and selective job placement
submit requests for reimbursement for reimburse miners promptly for all bills assistance.
covered medical expenses and received on an approved form and in a
transportation costs? § 725.720 How does a miner request
timely manner. However, absent good
cause, no bill will be paid for expenses vocational rehabilitation assistance?
(a) If a miner has paid bills for a
medical service or treatment covered incurred if the bill is submitted more Each miner who has been determined
under § 725.701 and seeks than one year beyond the end of the entitled to receive benefits under part C
reimbursement for those expenses, he or calendar year in which the expense was of title IV of the Act must be informed
she may submit a request for incurred or the service or supply was by OWCP of the availability and
reimbursement on Form OWCP–915, provided, or more than one year beyond advisability of vocational rehabilitation
together with an itemized bill. The the end of the calendar year in which services. If such miner chooses to avail
reimbursement request must be the miner’s eligibility for benefits is himself or herself of vocational
finally adjudicated, whichever is later. rehabilitation, his or her request will be
accompanied by evidence that the
A provider may not request processed and referred by OWCP
provider received payment for the
reimbursement from a miner for a bill vocational rehabilitation advisors
service from the miner and a statement
denied by OWCP due to late submission pursuant to the provisions of §§ 702.501
of the amount paid. Acceptable
of the bill by the provider. through 702.508 of this chapter as is
evidence that payment was received
appropriate.
includes, but is not limited to, a copy § 725.718 How are disputes concerning
of the miner’s canceled check (both Dated: June 5, 2018.
medical benefits resolved?
front and back) or a copy of the miner’s Julia K. Hearthway,
(a) If a dispute develops concerning
credit card receipt. medical services or treatments or their Director, Office of Workers’ Compensation
Programs.
(b) OWCP may waive the payment under this part, OWCP must
[FR Doc. 2018–12418 Filed 6–13–18; 8:45 am]
requirements of paragraph (a) of this attempt to informally resolve the
section if extensive delays in the filing dispute. OWCP may, on its own BILLING CODE 4510–CR–P
or the adjudication of a claim make it initiative or at the request of the
unusually difficult for the miner to responsible operator or its insurance
obtain the required information. carrier, order the claimant to submit to DEPARTMENT OF HEALTH AND
an examination by a physician selected HUMAN SERVICES
(c) Reimbursements for covered
medical services paid by a miner by OWCP.
(b) If a dispute cannot be resolved Food and Drug Administration
generally will be no greater than the
maximum allowable charge for such informally, OWCP will refer the case to
the Office of Administrative Law Judges 21 CFR Part 866
service as determined under
§§ 725.707–725.711. for a hearing in accordance with this [Docket No. FDA–2018–N–1928]
part. Any such hearing concerning
(d) A miner will be only partially authorization of medical services or Medical Devices; Immunology and
reimbursed for a covered medical treatments must be scheduled at the Microbiology Devices; Classification of
service if the amount he or she paid to earliest possible time and must take the Brain Trauma Assessment Test
a provider for the service exceeds the precedence over all other hearing
maximum charge allowable. If this AGENCY: Food and Drug Administration,
requests except for other requests under HHS.
happens, OWCP will advise the miner this section and as provided by
of the maximum allowable charge for § 727.405 of this subchapter (see ACTION: Final order.
the service in question and of his or her § 725.4(d)). During the pendency of such SUMMARY: The Food and Drug
responsibility to ask the provider to adjudication, OWCP may order the Administration (FDA or we) is
refund to the miner, or credit to the payment of medical benefits prior to classifying the brain trauma assessment
miner’s account, the amount he or she final adjudication under the same test into class II (special controls). The
paid which exceeds the maximum conditions applicable to benefits special controls that apply to the device
allowable charge. awarded under § 725.522. type are identified in this order and will
(e) If the provider does not refund to (c) In the development or adjudication be part of the codified language for the
the miner or credit to his or her account of a dispute over medical benefits, the brain trauma assessment test’s
the amount of money paid in excess of adjudication officer is authorized to take classification. We are taking this action
the charge allowed by OWCP, the miner whatever action may be necessary to because we have determined that
should submit documentation to OWCP protect the health of a totally disabled classifying the device into class II
of the attempt to obtain such refund or miner. (special controls) will provide a
credit. OWCP may make reasonable (d) Any interested medical provider reasonable assurance of safety and
reimbursement to the miner after may, if appropriate, be made a party to effectiveness of the device. We believe
reviewing the facts and circumstances of a dispute under this subpart. this action will also enhance patients’
the case. § 725.719 What is the objective of access to beneficial innovative devices,
(f) If a miner has paid transportation vocational rehabilitation? in part by reducing regulatory burdens.
daltland on DSKBBV9HB2PROD with RULES
costs or other incidental expenses The objective of vocational DATES: This order is effective June 14,
related to covered medical services rehabilitation is the return of a miner 2018. The classification was applicable
under this part, the miner may submit who is totally disabled by on February 14, 2018.
a request for reimbursement on Form pneumoconiosis to gainful employment FOR FURTHER INFORMATION CONTACT: Erin
OWCP–957 or OWCP–915, together commensurate with such miner’s Cutts, Center for Devices and
with proof of payment. physical impairment. This objective Radiological Health, Food and Drug
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![27702 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations
(2) The 21 CFR 809.10(a) and (b) Administration, 10903 New Hampshire receiving an order from FDA classifying
compliant labeling must include the Ave., Bldg. 66, Rm. G223, Silver Spring, the device into class III under section
following limitations: MD 20993–0002, 240–402–9979, 513(f)(1) of the FD&C Act, the person
(i) A limiting statement that this Purva.Pandya@fda.hhs.gov. then requests a classification under
device is not intended to be used a SUPPLEMENTARY INFORMATION: section 513(f)(2).
stand-alone device but as an adjunct to Under the second procedure, rather
other clinical information to aid in the I. Background
than first submitting a 510(k) and then
evaluation of patients who are being Upon request, FDA has classified the a request for classification, if the person
considered for standard of care endoscopic electrosurgical clip cutting determines that there is no legally
neuroimaging. system as class II (special controls), marketed device upon which to base a
(ii) A limiting statement that reads ‘‘A which we have determined will provide determination of substantial
negative result is generally associated a reasonable assurance of safety and equivalence, that person requests a
with the absence of acute intracranial effectiveness. In addition, we believe classification under section 513(f)(2) of
lesions. An appropriate neuroimaging this action will enhance patients’ access the FD&C Act.
method is required for diagnosis of to beneficial innovation, in part by Under either procedure for De Novo
acute intracranial lesions.’’ reducing regulatory burdens by placing classification, FDA shall classify the
(iii) As applicable, a limiting the device into a lower device class than device by written order within 120 days.
statement that reads ‘‘This device is for the automatic class III assignment. The classification will be according to
use by laboratory professionals in a The automatic assignment of class III the criteria under section 513(a)(1) of
clinical laboratory setting.’’ occurs by operation of law and without the FD&C Act. Although the device was
any action by FDA, regardless of the automatically within class III, the De
Dated: June 8, 2018.
level of risk posed by the new device. Novo classification is considered to be
Leslie Kux, Any device that was not in commercial
Associate Commissioner for Policy. the initial classification of the device.
distribution before May 28, 1976, is
[FR Doc. 2018–12760 Filed 6–13–18; 8:45 am] We believe this De Novo classification
automatically classified as, and remains
will enhance patients’ access to
BILLING CODE 4164–01–P within, class III and requires premarket
beneficial innovation, in part by
approval unless and until FDA takes an
action to classify or reclassify the device reducing regulatory burdens. When FDA
DEPARTMENT OF HEALTH AND (see 21 U.S.C. 360c(f)(1)). We refer to classifies a device into class I or II via
HUMAN SERVICES these devices as ‘‘postamendments the De Novo process, the device can
devices’’ because they were not in serve as a predicate for future devices of
Food and Drug Administration commercial distribution prior to the that type, including for 510(k)s. As a
date of enactment of the Medical Device result, other device sponsors do not
21 CFR Part 876 Amendments of 1976, which amended have to submit a De Novo request or
the Federal Food, Drug, and Cosmetic PMA in order to market a substantially
[Docket No. FDA–2018–N–1862]
Act (FD&C Act). equivalent device (see 21 U.S.C. 360c(i),
Medical Devices; Gastroenterology- FDA may take a variety of actions in defining ‘‘substantial equivalence’’).
Urology Devices; Classification of the appropriate circumstances to classify or Instead, sponsors can use the less-
Endoscopic Electrosurgical Clip reclassify a device into class I or II. We burdensome 510(k) process, when
Cutting System may issue an order finding a new device necessary, to market their device.
to be substantially equivalent under II. De Novo Classification
AGENCY: Food and Drug Administration, section 513(i) of the FD&C Act to a
HHS. predicate device that does not require On April 11, 2016, Ovesco Endoscopy
ACTION: Final order. premarket approval (see 21 U.S.C. AG submitted a request for De Novo
360c(i)). We determine whether a new classification of the remOVE System.
SUMMARY: The Food and Drug FDA reviewed the request in order to
device is substantially equivalent to a
Administration (FDA or we) is classify the device under the criteria for
predicate by means of the procedures
classifying the endoscopic classification set forth in section
for premarket notification under section
electrosurgical clip cutting system into 513(a)(1) of the FD&C Act.
510(k) of the FD&C Act (21 U.S.C.
class II (special controls). The special We classify devices into class II if
360(k)) and part 807 (21 CFR part 807),
controls that apply to the device type general controls by themselves are
respectively).
are identified in this order and will be FDA may also classify a device insufficient to provide reasonable
part of the codified language for the through ‘‘De Novo’’ classification, a assurance of safety and effectiveness,
endoscopic electrosurgical clip cutting common name for the process but there is sufficient information to
system’s classification. We are taking authorized under section 513(f)(2) of the establish special controls that, in
this action because we have determined FD&C Act. Section 207 of the Food and combination with the general controls,
that classifying the device into class II Drug Administration Modernization Act provide reasonable assurance of the
(special controls) will provide a of 1997 established the first procedure safety and effectiveness of the device for
reasonable assurance of safety and for De Novo classification (Pub. L. 105– its intended use (see 21 U.S.C.
effectiveness of the device. We believe 115). Section 607 of the Food and Drug 360c(a)(1)(B)). After review of the
this action will also enhance patients’ Administration Safety and Innovation information submitted in the request,
access to beneficial innovative devices, Act modified the De Novo application we determined that the device can be
in part by reducing regulatory burdens. classified into class II with the
daltland on DSKBBV9HB2PROD with RULES
process by adding a second procedure
DATES: This order is effective June 14, (Pub. L. 112–144). A device sponsor establishment of special controls. FDA
2018. The classification was applicable may utilize either procedure for De has determined that these special
on December 22, 2017. Novo classification. controls, in addition to the general
FOR FURTHER INFORMATION CONTACT: Under the first procedure, the person controls, will provide reasonable
Purva Pandya, Center for Devices and submits a 510(k) for a device that has assurance of the safety and effectiveness
Radiological Health, Food and Drug not previously been classified. After of the device.
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Document Created: 2018-06-14 01:38:53
Document Modified: 2018-06-14 01:38:53
| 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 June 14, 2018. The classification was applicable on February 14, 2018. | |
| Contact | Erin Cutts, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5618, Silver Spring, MD 20993-0002, 301-796-6307, [email protected] | |
| FR Citation | 83 FR 27699 | |
| CFR Associated | Biologics; Laboratories and Medical Devices |
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