82 FR 61163 - Medical Devices; Hematology and Pathology Devices; Classification of the Flow Cytometric Test System for Hematopoietic Neoplasms
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 247 (December 27, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 247 (December 27, 2017)
| Page Range | 61163-61166 | |
| FR Document | 2017-27855 |
[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)] [Rules and Regulations] [Pages 61163-61166] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27855] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 864 [Docket No. FDA-2017-N-6643] Medical Devices; Hematology and Pathology Devices; Classification of the Flow Cytometric Test System for Hematopoietic Neoplasms AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the flow cytometric test system for hematopoietic neoplasms 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 flow cytometric test system for hematopoietic neoplasms' 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 December 27, 2017. The classification was applicable on June 29, 2017. FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4545, Silver Spring, MD 20993-0002, 240-402-6357, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the flow cytometric test system for hematopoietic neoplasms as class II (special controls), which we have [[Page 61164]] 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 and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively). 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 October 3, 2016, Beckman Coulter submitted a request for De Novo classification of the ClearLLab Reagents (T1, T2, B1, B2, M). 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 June 29, 2017, 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 864.7010. We have named the generic type of device flow cytometric test system for hematopoietic neoplasms, and it is identified as a device that consists of reagents for immunophenotyping of human cells in relation to the level of expression, antigen density, and distribution of specific cellular markers. These reagents are used as an aid in the differential diagnosis or monitoring of hematologically abnormal patients having or suspected of having hematopoietic neoplasms. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings. 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--Flow Cytometric Test for Hematopoietic Neoplasms Risks and Mitigation Measures ------------------------------------------------------------------------ Mitigation measures/21 CFR Identified risks section ------------------------------------------------------------------------ Incorrect test results (false negatives General Controls and Special or false positives). Controls (1) and (2) (21 CFR 864.7010(b)(1) and (2)). Incorrect interpretation of device General Controls and Special results by the end user. Controls (1), (2), and (3) (21 CFR 864.7010(b)(1), (2), and (3)). Patient harm from specimen(s) General Controls and Special collection. Control (1) (21 CFR 864.7010(b)(1)). ------------------------------------------------------------------------ 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 61165]] 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. 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; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; 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 864 Blood, Medical devices, Packaging and containers. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 864 is amended as follows: PART 864--HEMATOLOGY AND PATHOLOGY DEVICES 0 1. The authority citation for part 864 is revised to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 864.7010 to subpart H to read as follows: Sec. 864.7010 Flow cytometric test system for hematopoietic neoplasms. (a) Identification. A flow cytometric test for hematopoietic neoplasms is a device that consists of reagents for immunophenotyping of human cells in relation to the level of expression, antigen density, and distribution of specific cellular markers. These reagents are used as an aid in the differential diagnosis or monitoring of hematologically abnormal patients having or suspected of having hematopoietic neoplasms. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings. (b) Classification. Class II (special controls). The special controls for this device are: (1) Premarket notification submissions must include the following information: (i) The indications for use must indicate the clinical hematopoietic neoplasms for which the assay was designed and validated, for example, chronic leukemia or lymphoma. (ii) A detailed device description including the following: (A) A detailed description of all test components, all required reagents, and all instrumentation and equipment, including illustrations or photographs of nonstandard equipment or methods. (B) Detailed documentation of the device software including, but not limited to, standalone software applications and hardware-based devices that incorporate software. (C) A detailed description of methodology and assay procedure. (D) A description of appropriate internal and external quality control materials that are recommended or provided. The description must identify those control elements that are incorporated into the testing procedure, if applicable. (E) Detailed specifications for sample collection, processing, and storage. (F) Detailed specification of the criteria for test results interpretation and reporting including pre-established templates. (G) If applicable, based on the output of the results, a description of the specific number of events to collect, result outputs, and analytical sensitivity of the assay that will be reported. (iii) Information that demonstrates the performance characteristics of the test, including: (A) Device performance data from either a method comparison study comparing the specific lymphocyte cell markers to a predicate device or data collected through a clinical study demonstrating clinical validity using well-characterized clinical specimens. Samples must be representative of the intended use population of the device including hematologic neoplasms and the specific sample types for which the test is indicated for use. (B) If applicable, device performance data from a clinical study demonstrating clinical validity for parameters not established in a predicate device of this generic type using well-characterized prospectively obtained clinical specimens including all hematologic neoplasms and the specific sample types for which the device is indicated for use. (C) Device precision data using clinical samples to evaluate the within-lot, between-lot, within-run, between run, site-to-site and total variation using a minimum of three sites, of which at least two sites must be external sites. Results shall be reported as the standard deviation and percentage coefficient of variation for each level tested. (D) Reproducibility data generated using a minimum of three lots of reagents to evaluate mean fluorescence intensity and variability of the recovery of the different markers and/or cell populations. (E) Data from specimen and reagent carryover testing performed using well-established methods (e.g., CLSI H26-A2). (F) Specimen and prepared sample stability data established for each specimen matrix in the anticoagulant combinations and storage/use conditions that will be indicated. (G) A study testing anticoagulant equivalency in all claimed specimen type/anticoagulant combinations using clinical specimens that are representative of the intended use population of the device. (H) Analytic sensitivity data using a dilution panel created from clinical samples. (I) Analytical specificity data, including interference and cross- contamination. (J) Device stability data, including real-time stability of reagents under various storage times and temperatures. (K) For devices that include polyclonal antibodies, Fluorescence Minus One (FMO) studies to evaluate non-specific binding for all polyclonal antibodies. Each FMO tube is compared to reagent reference to demonstrate that no additional population appears when one marker is absent. Pre-specified acceptance criteria must be provided and followed. (L) For devices indicated for use as a semi-quantitative test, linearity data using a dilution panel created from clinical samples. (M) For devices indicated for use as a semi-quantitative test, clinically relevant analytical sensitivity data, [[Page 61166]] including limit of blank, limit of detection, and limit of quantification. (iv) Identification of risk mitigation elements used by the device, including a detailed description of all additional procedures, methods, and practices incorporated into the instructions for use that mitigate risks associated with testing the device. (2) The 21 CFR 809.10 compliant labeling must include the following: (i) The intended use statement in the 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include a statement that the results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings. The intended use statement must also include information on what the device detects and measures, whether the device is qualitative, semi-quantitative, and/or quantitative, the clinical indications for which the device is to be used, and the specific population(s) for which the device is intended. (ii) A detailed description of the performance studies conducted to comply with paragraph (b)(1)(iii) of this section and a summary of the results. (3) As part of the risk management activities performed under 21 CFR 820.30 design controls, product labeling and instruction manuals must include clear examples of all expected phenotypic patterns and gating strategies using well-defined clinical samples representative of both abnormal and normal cellular populations. These samples must be selected based upon the indications described in paragraph (b)(1)(i) of this section. Dated: December 20, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27855 Filed 12-26-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations 61163
Therefore, on November 19, 2013, instrument test systems, and it is to be used together, and labeled nucleic
FDA issued an order to the requestor identified as reagents other than analyte acid molecules.
classifying the device into class I. FDA specific reagents used as part of FDA has identified the following risks
is codifying the classification of the molecular diagnostic test systems, such to health associated specifically with
device by adding 21 CFR 862.3800. We as polymerases, nucleotides and this type of device in table 1.
have named the generic type of device nucleotide mixes, master mixes in
reagents for molecular diagnostic which individual reagents are optimized
TABLE 1—REAGENTS FOR MOLECULAR DIAGNOSTIC INSTRUMENT TEST SYSTEMS RISKS AND MITIGATION MEASURES
Identified risks Mitigation measures
Inaccurate test results due to inconsistently manufactured test system General controls, including current good manufacturing practices.
reagents.
Section 510(l)(1) of the FD&C Act the collections of information in 21 CFR DEPARTMENT OF HEALTH AND
provides that a device within a type that part 820, regarding current good HUMAN SERVICES
has been classified into class I under manufacturing practices, have been
section 513 of the FD&C Act is exempt approved under OMB control number Food and Drug Administration
from premarket notification under 0910–0073.
section 510(k), unless the device is of 21 CFR Part 864
substantial importance in preventing List of Subjects in 21 CFR Part 862
[Docket No. FDA–2017–N–6643]
impairment of human health or presents
Medical devices.
a potentially unreasonable risk of illness Medical Devices; Hematology and
or injury (21 U.S.C. 360(l)(1)). Devices Therefore, under the Federal Food, Pathology Devices; Classification of
within this type are exempt from the Drug, and Cosmetic Act and under the Flow Cytometric Test System for
premarket notification requirements authority delegated to the Commissioner Hematopoietic Neoplasms
under section 510(k), subject to the of Food and Drugs, 21 CFR part 862 is
limitations of exemptions in 21 CFR AGENCY: Food and Drug Administration,
amended as follows: HHS.
862.9.
PART 862—CLINICAL CHEMISTRY ACTION: Final order.
III. Analysis of Environmental Impact
AND CLINICAL TOXICOLOGY SUMMARY: The Food and Drug
The Agency has determined under 21 DEVICES
CFR 25.34(b) that this action is of a type Administration (FDA or we) is
that does not individually or classifying the flow cytometric test
■ 1. The authority citation for part 862 system for hematopoietic neoplasms
cumulatively have a significant effect on
the human environment. Therefore, continues to read as follows: into class II (special controls). The
neither an environmental assessment Authority: 21 U.S.C. 351, 360, 360c, 360e, special controls that apply to the device
nor an environmental impact statement 360j, 360l, 371. type are identified in this order and will
is required. be part of the codified language for the
■ 2. Add § 862.3800 to subpart D to read flow cytometric test system for
IV. Paperwork Reduction Act of 1995 as follows: hematopoietic neoplasms’ classification.
This final order refers to previously We are taking this action because we
§ 862.3800 Reagents for molecular have determined that classifying the
approved collections of information
diagnostic instrument test systems. device into class II (special controls)
found in other FDA regulations. These
collections of information are subject to (a) Identification. Reagents for will provide a reasonable assurance of
review by the Office of Management and molecular diagnostic test systems are safety and effectiveness of the device.
Budget (OMB) under the Paperwork reagents other than analyte specific We believe this action will also enhance
Reduction Act of 1995 (44 U.S.C. 3501– reagents used as part of molecular patients’ access to beneficial innovative
3520). The collections of information in diagnostic test systems, such as devices, in part by reducing regulatory
the guidance document ‘‘De Novo polymerases, nucleotides and burdens.
Classification Process (Evaluation of nucleotide mixes, master mixes in DATES: This order is effective December
Automatic Class III Designation)’’ have which individual reagents are optimized 27, 2017. The classification was
been approved under OMB control to be used together, and labeled nucleic applicable on June 29, 2017.
number 0910–0844; the collections of acid molecules. FOR FURTHER INFORMATION CONTACT:
information in 21 CFR parts 801 and Ryan Lubert, Center for Devices and
809, regarding labeling, have been (b) Classification. Class I (general Radiological Health, Food and Drug
approved under OMB control number controls). The device is exempt from the Administration, 10903 New Hampshire
0910–0485; the collections of premarket notification procedure in Ave., Bldg. 66, Rm. 4545, Silver Spring,
information in 21 CFR part 814, subpart E of part 807 of this chapter, MD 20993–0002, 240–402–6357,
subparts A through E, regarding subject to the limitations in § 862.9. ryan.lubert@fda.hhs.gov.
premarket approval, have been
daltland on DSKBBV9HB2PROD with RULES
Dated: December 20, 2017. SUPPLEMENTARY INFORMATION:
approved under OMB control number Leslie Kux,
0910–0231; the collections of I. Background
information in part 807, subpart E, Associate Commissioner for Policy. Upon request, FDA has classified the
regarding premarket notification [FR Doc. 2017–27853 Filed 12–26–17; 8:45 am] flow cytometric test system for
submissions, have been approved under BILLING CODE 4164–01–P hematopoietic neoplasms as class II
OMB control number 0910–0120; and (special controls), which we have
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![61166 Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations
including limit of blank, limit of classifying the computerized behavioral We determine whether a new device is
detection, and limit of quantification. therapy device for psychiatric disorders substantially equivalent to a predicate
(iv) Identification of risk mitigation into class II (special controls). The by means of the procedures for
elements used by the device, including special controls that apply to the device premarket notification under section
a detailed description of all additional type are identified in this order and will 510(k) of the FD&C Act and part 807 (21
procedures, methods, and practices be part of the codified language for the U.S.C. 360(k) and 21 CFR part 807,
incorporated into the instructions for computerized behavioral therapy device respectively).
use that mitigate risks associated with for psychiatric disorders’ classification. FDA may also classify a device
testing the device. We are taking this action because we
(2) The 21 CFR 809.10 compliant through ‘‘De Novo’’ classification, a
have determined that classifying the common name for the process
labeling must include the following: device into class II (special controls)
(i) The intended use statement in the authorized under section 513(f)(2) of the
will provide a reasonable assurance of FD&C Act. Section 207 of the Food and
21 CFR 809.10(a)(2) and (b)(2) safety and effectiveness of the device.
compliant labeling must include a Drug Administration Modernization Act
We believe this action will also enhance of 1997 established the first procedure
statement that the results should be patients’ access to beneficial innovative
interpreted by a pathologist or for De Novo classification (Pub. L. 105–
devices, in part by reducing regulatory
equivalent professional in conjunction 115). Section 607 of the Food and Drug
burdens.
with other clinical and laboratory Administration Safety and Innovation
DATES: This order is effective December Act modified the De Novo application
findings. The intended use statement
27, 2017. The classification was process by adding a second procedure
must also include information on what
applicable on September 14, 2017. (Pub. L. 112–144). A device sponsor
the device detects and measures,
FOR FURTHER INFORMATION CONTACT: may utilize either procedure for De
whether the device is qualitative, semi-
quantitative, and/or quantitative, the Patrick Antkowiak, Center for Devices Novo classification.
clinical indications for which the device and Radiological Health, Food and Drug
Under the first procedure, the person
is to be used, and the specific Administration, 10903 New Hampshire
submits a 510(k) for a device that has
population(s) for which the device is Ave., Bldg. 66, Rm. 2663, Silver Spring,
MD 20993–0002, 240–402–3705, not previously been classified. After
intended. receiving an order from FDA classifying
(ii) A detailed description of the Patrick.Antkowiak@fda.hhs.gov.
the device into class III under section
performance studies conducted to SUPPLEMENTARY INFORMATION:
513(f)(1) of the FD&C Act, the person
comply with paragraph (b)(1)(iii) of this I. Background then requests a classification under
section and a summary of the results. section 513(f)(2).
(3) As part of the risk management Upon request, FDA has classified the
activities performed under 21 CFR computerized behavioral therapy device Under the second procedure, rather
820.30 design controls, product labeling for psychiatric disorders as class II than first submitting a 510(k) and then
and instruction manuals must include (special controls), which we have a request for classification, if the person
clear examples of all expected determined will provide a reasonable determines that there is no legally
phenotypic patterns and gating assurance of safety and effectiveness. In marketed device upon which to base a
strategies using well-defined clinical addition, we believe this action will determination of substantial
samples representative of both abnormal enhance patients’ access to beneficial equivalence, that person requests a
and normal cellular populations. These innovation, in part by reducing classification under section 513(f)(2) of
samples must be selected based upon regulatory burdens by placing the the FD&C Act.
the indications described in paragraph device into a lower device class than the Under either procedure for De Novo
(b)(1)(i) of this section. automatic class III assignment. classification, FDA shall classify the
The automatic assignment of class III device by written order within 120 days.
Dated: December 20, 2017.
occurs by operation of law and without The classification will be according to
Leslie Kux, any action by FDA, regardless of the
Associate Commissioner for Policy. the criteria under section 513(a)(1) of
level of risk posed by the new device. the FD&C Act. Although the device was
[FR Doc. 2017–27855 Filed 12–26–17; 8:45 am] Any device that was not in commercial automatically placed within class III,
BILLING CODE 4164–01–P distribution before May 28, 1976, is the De Novo classification is considered
automatically classified as, and remains
to be the initial classification of the
within, class III and requires premarket
DEPARTMENT OF HEALTH AND device.
approval unless and until FDA takes an
HUMAN SERVICES action to classify or reclassify the device We believe this De Novo classification
(see 21 U.S.C. 360c(f)(1)). We refer to will enhance patients’ access to
Food and Drug Administration beneficial innovation, in part by
these devices as ‘‘postamendments
devices’’ because they were not in reducing regulatory burdens. When FDA
21 CFR Part 882 classifies a device into class I or II via
commercial distribution prior to the
[Docket No. FDA–2017–N–6642] date of enactment of the Medical Device the De Novo process, the device can
Amendments of 1976, which amended serve as a predicate for future devices of
Medical Devices; Neurological the Federal Food, Drug, and Cosmetic that type, including for 510(k)s (see 21
Devices; Classification of the Act (FD&C Act). U.S.C. 360c(f)(2)(B)(i)). As a result, other
Computerized Behavioral Therapy FDA may take a variety of actions in device sponsors do not have to submit
Device for Psychiatric Disorders appropriate circumstances to classify or a De Novo request or premarket
daltland on DSKBBV9HB2PROD with RULES
AGENCY: Food and Drug Administration, reclassify a device into class I or II. We approval application in order to market
HHS. may issue an order finding a new device a substantially equivalent device (see 21
ACTION: Final order. to be substantially equivalent under U.S.C. 360c(i), defining ‘‘substantial
section 513(i) of the FD&C Act (21 equivalence’’). Instead, sponsors can use
SUMMARY: The Food and Drug U.S.C. 360c(i)) to a predicate device that the less-burdensome 510(k) process,
Administration (FDA or we) is does not require premarket approval. when necessary, to market their device.
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Document Created: 2017-12-27 02:23:46
Document Modified: 2017-12-27 02:23:46
| 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 December 27, 2017. The classification was applicable on June 29, 2017. | |
| Contact | Ryan Lubert, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4545, Silver Spring, MD 20993-0002, 240-402-6357, [email protected] | |
| FR Citation | 82 FR 61163 | |
| CFR Associated | Blood; Medical Devices and Packaging and Containers |
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