82 FR 47965 - Medical Devices; Immunology and Microbiology Devices; Classification of the Nucleic Acid-Based Device for the Amplification, Detection, and Identification of Microbial Pathogens Directly From Whole Blood Specimens
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 198 (October 16, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 198 (October 16, 2017)
| Page Range | 47965-47967 | |
| FR Document | 2017-22287 |
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)] [Rules and Regulations] [Pages 47965-47967] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22287] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2017-N-5296] Medical Devices; Immunology and Microbiology Devices; Classification of the Nucleic Acid-Based Device for the Amplification, Detection, and Identification of Microbial Pathogens Directly From Whole Blood Specimens AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens 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 nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens' 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 October 16, 2017. The classification was applicable on September 22, 2014. FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens [[Page 47966]] directly from whole blood specimens 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 (the 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 to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). 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 is required to 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 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 PMA 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 May 27, 2014, T2 Biosystems, Inc., submitted a request for classification of the T2Candida Panel and T2Dx[supreg] Instrument. 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 general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on September 22, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.3960. We have named the generic type of device nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens, and it is identified as a qualitative in vitro device intended for the amplification, detection, and identification of microbial-associated nucleic acid sequences from patients with suspected bloodstream infections. This device is intended to aid in the diagnosis of bloodstream infection when used in conjunction with clinical signs and symptoms and other 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--Nucleic Acid-Based Device for the Amplification, Detection, and Identification of Microbial Pathogens Directly From Whole Blood Specimens Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigations measures ------------------------------------------------------------------------ Incorrect identification of a Special Controls (1), (2), (3), pathogenic microorganism by the device (4), and (5). can lead to improper patient management. Failure to correctly interpret test Special Control (6). results. Failure to correctly operate the Special Controls (7) and (8). instrument. ------------------------------------------------------------------------ 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. In order 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 [[Page 47967]] subject to 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 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 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. 866.3960 to subpart D to read as follows: Sec. 866.3960 Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens. (a) Identification. A nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens is a qualitative in vitro device intended for the amplification, detection, and identification of microbial-associated nucleic acid sequences from patients with suspected bloodstream infections. This device is intended to aid in the diagnosis of bloodstream infection when used in conjunction with clinical signs and symptoms and other laboratory findings. (b) Classification. Class II (special controls). The special controls for this device are: (1) Premarket notification submissions must include detailed device description documentation, including the device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including primer/probe sequence, design, and rationale for sequence selection. (2) Premarket notification submissions must include detailed documentation from the following analytical and clinical performance studies: Analytical sensitivity (limit of detection), reactivity, inclusivity, precision, reproducibility, interference, cross reactivity, carryover, and cross contamination. (3) Premarket notification submissions must include detailed documentation from a clinical study. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from well-accepted reference methods. (4) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, software applications and hardware-based devices that incorporate software. (5) The device labeling must include limitations regarding the need for culture confirmation of negative specimens, as appropriate. (6) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling. (7) Premarket notification submissions must include details on an end user device training program that will be offered while marketing the device, as appropriate. (8) As part of the risk management activities performed as part of your 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument. Dated: October 10, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-22287 Filed 10-13-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 47965
‘‘significant rule’’ under DOT R–3004A Fort Gordon, GA [Amended] Issued in Washington, DC, on September
Regulatory Policies and Procedures (44 By removing the current designated 19, 2017.
FR 11034; February 26, 1979); and (3) altitudes and aircraft activity limitations and Rodger A. Dean, Jr.,
does not warrant preparation of a inserting the following in their places: Manager, Airspace Policy Group.
regulatory evaluation as the anticipated Designated Altitudes. Surface to but not [FR Doc. R1–2017–20435 Filed 10–13–17; 8:45 am]
impact is so minimal. Since this is a including 3,500 feet MSL. BILLING CODE 1301–00–D
routine matter that only affects air traffic Aircraft activity is limited to the following
terms and conditions:
procedures and air navigation, it is 1. Aircraft activities must not be conducted
certified that this rule, when on weekends, national holidays, or from the DEPARTMENT OF HEALTH AND
promulgated, does not have a significant Sunday prior to the Masters Golf Tournament HUMAN SERVICES
economic impact on a substantial through the Monday after (and subsequent
number of small entities under the weather days if required). Food and Drug Administration
criteria of the Regulatory Flexibility Act. 2. Aircraft activities may only be
conducted from the surface to 12,000 feet 21 CFR Part 866
Environmental Review AGL.
[Docket No. FDA–2017–N–5296]
3. Weather conditions required for aircraft
The FAA has determined that this activities are 5 miles visibility and with
action of vertically subdividing limits of Medical Devices; Immunology and
prevailing clouds or obscuring phenomena
existing restricted airspace within the no greater than five-tenths coverage of the
Microbiology Devices; Classification of
current lateral and vertical limits sky and bases no lower than 3,000 feet AGL. the Nucleic Acid-Based Device for the
qualifies for categorical exclusion under Amplification, Detection, and
R–3004B Fort Gordon, GA [Amended] Identification of Microbial Pathogens
the National Environmental Policy Act
By removing the current designated Directly From Whole Blood Specimens
and in accordance with FAA Order altitudes and aircraft activity limitations and
1050.1F—Environmental Impacts: inserting the following in their places: AGENCY: Food and Drug Administration,
Policies and Procedures, Categorical Designated Altitudes. 3,500 feet MSL to but HHS.
Exclusions for Procedural Actions, not including 7,000 feet MSL. ACTION: Final order.
paragraph 5–6.5d—Modification of the Aircraft activity is limited to the following
technical description of special use terms and conditions: SUMMARY: The Food and Drug
airspace (restricted areas) that does not 1. Aircraft activities must not be conducted Administration (FDA or we) is
alter the dimensions, altitudes, or times on weekends, national holidays, or from the classifying the nucleic acid-based
Sunday prior to the Masters Golf Tournament device for the amplification, detection,
of designation of the airspace.
through the Monday after (and subsequent and identification of microbial
Therefore, this airspace action is not weather days if required).
expected to result in any significant pathogens directly from whole blood
2. Aircraft activities may only be
environmental impacts. In accordance specimens into class II (special
conducted from the surface to 12,000 feet
with FAAO 1050.1F, paragraph 5–2 AGL.
controls). The special controls that
regarding Extraordinary Circumstances, 3. Weather conditions required for aircraft apply to the device type are identified
activities are 5 miles visibility and with in this order and will be part of the
this action has been reviewed for factors
prevailing clouds or obscuring phenomena codified language for the nucleic acid-
and circumstances in which a normally
no greater than five-tenths coverage of the based device for the amplification,
categorically excluded action may have
sky and bases no lower than 3,000 feet AGL. detection, and identification of
a significant environmental impact microbial pathogens directly from
requiring further analysis, and it is R–3004C Fort Gordon, GA [New]
whole blood specimens’ classification.
determined that no extraordinary Boundaries. Beginning at lat. 33°21′54″ N., We are taking this action because we
circumstances exist that warrant long. 82°12′14″ W.; to lat. 33°19′44″ N., long.
have determined that classifying the
preparation of an environmental 82°12′14″ W.; to lat. 33°16′21″ N., long.
82°17′59″ W.; to lat. 33°17′30″ N., long.
device into class II (special controls)
assessment. will provide a reasonable assurance of
82°22′59″ W.; to lat. 33°21′16″ N., long.
List of Subjects in 14 CFR Part 73 82°18′46″ W.; to lat. 33°22′16″ N., long. safety and effectiveness of the device.
82°16′59″ W.; to the point of beginning. We believe this action will also enhance
Airspace, prohibited areas, restricted Designated Altitudes. 7,000 feet MSL to patients’ access to beneficial innovative
areas. 16,000 feet MSL. devices, in part by reducing regulatory
Times of designation. By NOTAM 24 hours burdens.
Adoption of the Amendment in advance. DATES: This order is effective October
Controlling agency. FAA, Atlanta ARTCC. 16, 2017. The classification was
In consideration of the foregoing, the Using agency. U.S. Army, Commanding
Federal Aviation Administration Officer, Fort Gordon, GA.
applicable on September 22, 2014.
amends 14 CFR part 73, as follows: Aircraft activity is limited to the following FOR FURTHER INFORMATION CONTACT:
terms and conditions: Steven Tjoe, Center for Devices and
PART 73—SPECIAL USE AIRSPACE 1. Aircraft activities must not be conducted Radiological Health, Food and Drug
on weekends, national holidays, or from the Administration, 10903 New Hampshire
■ 1. The authority citation for part 73 Sunday prior to the Masters Golf Tournament Ave., Bldg. 66, Rm. 4550, Silver Spring,
continues to read as follows: through the Monday after (and subsequent MD 20993–0002, 301–796–5866,
weather days if required). steven.tjoe@fda.hhs.gov.
Authority: 49 U.S.C. 106(f), 106(g); 40103,
jstallworth on DSKBBY8HB2PROD with RULES
2. Aircraft activities may only be
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, conducted from the surface to 12,000 feet SUPPLEMENTARY INFORMATION:
1959–1963 Comp., p. 389. AGL. I. Background
3. Weather conditions required for aircraft
§ 73.30 [Amended] activities are 5 miles visibility and with Upon request, FDA has classified the
prevailing clouds or obscuring phenomena nucleic acid-based device for the
■ 2. § 73.30 is amended as follows: no greater than five-tenths coverage of the amplification, detection, and
* * * * * sky and bases no lower than 3,000 feet AGL. identification of microbial pathogens
VerDate Sep<11>2014 14:58 Oct 13, 2017 Jkt 244001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\16OCR1.SGM 16OCR1](https://thefederalregister.org/doc/82_FR_48163/page/1.svg)
![Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 47967
subject to premarket notification This device is intended to aid in the DEPARTMENT OF HEALTH AND
requirements under section 510(k) of the diagnosis of bloodstream infection when HUMAN SERVICES
FD&C Act. used in conjunction with clinical signs
and symptoms and other laboratory Food and Drug Administration
III. Analysis of Environmental Impact
findings.
The Agency has determined under 21 (b) Classification. Class II (special 21 CFR Part 866
CFR 25.34(b) that this action is of a type controls). The special controls for this [Docket No. FDA–2017–N–5714]
that does not individually or device are:
cumulatively have a significant effect on (1) Premarket notification Medical Devices; Immunology and
the human environment. Therefore, submissions must include detailed Microbiology Devices; Classification of
neither an environmental assessment device description documentation, the Automated Image Assessment
nor an environmental impact statement including the device components, System for Microbial Colonies on Solid
is required. ancillary reagents required but not Culture Media
IV. Paperwork Reduction Act of 1995 provided, and a detailed explanation of
the methodology, including primer/ AGENCY: Food and Drug Administration,
This final order establishes special HHS.
probe sequence, design, and rationale
controls that refer to previously ACTION: Final order.
for sequence selection.
approved collections of information
found in other FDA regulations. These (2) Premarket notification
SUMMARY: The Food and Drug
collections of information are subject to submissions must include detailed
Administration (FDA or we) is
review by the Office of Management and documentation from the following
classifying the automated image
Budget (OMB) under the Paperwork analytical and clinical performance
assessment system for microbial
Reduction Act of 1995 (44 U.S.C. 3501– studies: Analytical sensitivity (limit of
colonies on solid culture media into
3520). The collections of information in detection), reactivity, inclusivity,
class II (special controls). The special
part 807, subpart E, regarding premarket precision, reproducibility, interference,
controls that apply to the device type
notification submissions have been cross reactivity, carryover, and cross
are identified in this order and will be
approved under OMB control number contamination.
part of the codified language for the
0910–0120, the collections of (3) Premarket notification automated image assessment system for
information in 21 CFR part 820 have submissions must include detailed microbial colonies on solid culture
been approved under OMB control documentation from a clinical study. media’s classification. We are taking
number 0910–0073, and the collections The study, performed on a study this action because we have determined
of information in 21 CFR parts 801 and population consistent with the intended that classifying the device into class II
809, regarding labeling have been use population, must compare the (special controls) will provide a
approved under OMB control number device performance to results obtained reasonable assurance of safety and
0910–0485. from well-accepted reference methods. effectiveness of the device. We believe
(4) Premarket notification this action will also enhance patients’
List of Subjects in 21 CFR Part 866 submissions must include detailed access to beneficial innovative devices,
Biologics, Laboratories, Medical documentation for device software, in part by reducing regulatory burdens.
devices. including, but not limited to, software
DATES: This order is effective October
Therefore, under the Federal Food, applications and hardware-based
devices that incorporate software. 16, 2017. The classification was
Drug, and Cosmetic Act and under applicable on October 6, 2016.
authority delegated to the Commissioner (5) The device labeling must include
limitations regarding the need for FOR FURTHER INFORMATION CONTACT:
of Food and Drugs, 21 CFR part 866 is
amended as follows: culture confirmation of negative Steven Tjoe, Center for Devices and
specimens, as appropriate. Radiological Health, Food and Drug
PART 866—IMMUNOLOGY AND (6) A detailed explanation of the Administration, 10903 New Hampshire
MICROBIOLOGY DEVICES interpretation of results and acceptance Ave., Bldg. 66, Rm. 4550, Silver Spring,
criteria must be included in the device’s MD 20993–0002, 301–796–5866
■ 1. The authority citation for part 866 21 CFR 809.10(b)(9) compliant labeling. Steven.Tjoe@fda.hhs.gov.
continues to read as follows: SUPPLEMENTARY INFORMATION:
(7) Premarket notification
Authority: 21 U.S.C. 351, 360, 360c, 360e, submissions must include details on an I. Background
360j, 360l, 371. end user device training program that
will be offered while marketing the Upon request, FDA has classified the
■ 2. Add § 866.3960 to subpart D to read automated image assessment system for
as follows: device, as appropriate.
(8) As part of the risk management microbial colonies on solid culture
§ 866.3960 Nucleic acid-based device for activities performed as part of your 21 media as class II (special controls),
the amplification, detection, and CFR 820.30 design controls, you must which we have determined will provide
identification of microbial pathogens
document an appropriate end user a reasonable assurance of safety and
directly from whole blood specimens. effectiveness. In addition, we believe
device training program that will be
(a) Identification. A nucleic acid- offered as part of your efforts to mitigate this action will enhance patients’ access
based device for the amplification, the risk of failure to correctly operate to beneficial innovation, in part by
detection, and identification of the instrument. reducing regulatory burdens by placing
jstallworth on DSKBBY8HB2PROD with RULES
microbial pathogens directly from the device into a lower device class than
whole blood specimens is a qualitative Dated: October 10, 2017. the automatic class III assignment.
in vitro device intended for the Anna K. Abram, The automatic assignment of class III
amplification, detection, and Deputy Commissioner for Policy, Planning, occurs by operation of law and without
identification of microbial-associated Legislation, and Analysis. any action by FDA, regardless of the
nucleic acid sequences from patients [FR Doc. 2017–22287 Filed 10–13–17; 8:45 am] level of risk posed by the new device.
with suspected bloodstream infections. BILLING CODE 4164–01–P Any device that was not in commercial
VerDate Sep<11>2014 14:58 Oct 13, 2017 Jkt 244001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\16OCR1.SGM 16OCR1](https://thefederalregister.org/doc/82_FR_48163/page/3.svg)
Document Created: 2017-10-14 01:42:54
Document Modified: 2017-10-14 01:42:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective October 16, 2017. The classification was applicable on September 22, 2014. | |
| Contact | Steven Tjoe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866, [email protected] | |
| FR Citation | 82 FR 47965 | |
| CFR Associated | Biologics; Laboratories and Medical Devices |
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