82 FR 48762 - Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 202 (October 20, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 202 (October 20, 2017)
| Page Range | 48762-48764 | |
| FR Document | 2017-22769 |
[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)] [Rules and Regulations] [Pages 48762-48764] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22769] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2017-N-5371] Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid'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 October 20, 2017. The classification was applicable on October 8, 2015. FOR FURTHER INFORMATION CONTACT: Kimberly Sconce, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4524, Silver Spring, MD, 20993-0002, 301- 796-6679, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid 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 (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 [[Page 48763]] 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 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 April 9, 2015, BioFire Diagnostics, LLC submitted a request for De Novo classification of the FilmArray[supreg] Meningitis/Encephalitis (ME) Panel. 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 October 8, 2015, 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 866.3970. We have named the generic type of device, device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid, and it is identified as a qualitative in vitro device intended for the detection and identification of microbial-associated nucleic acid sequences from patients suspected of meningitis or encephalitis. A device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid is intended to aid in the diagnosis of meningitis or encephalitis when used in conjunction with clinical signs and symptoms and 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--Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Incorrect identification or lack of Special Controls (1), identification of a pathogenic microorganism (2), (3), (4), and (5). by the device can lead to improper patient management. Failure to correctly interpret test results.. Special Controls (6), (7), (8), and (9). Failure to correctly operate the instrument.. Special Control (10). ------------------------------------------------------------------------ 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 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. 866.3970 to subpart D to read as follows: Sec. 866.3970 Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid. (a) Identification. A device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid is a qualitative in vitro device intended for the detection and identification of microbial- associated nucleic acid [[Page 48764]] sequences from patients suspected of meningitis or encephalitis. A device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid is intended to aid in the diagnosis of meningitis or encephalitis when used in conjunction with clinical signs and symptoms and other clinical and 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 studies: Analytical sensitivity (limit of detection), inclusivity, reproducibility, interference, cross reactivity, and specimen stability. (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 comparator 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 Intended Use statement in the device labeling must include a statement that the device is intended to be used in conjunction with standard of care culture. (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) The device labeling must include a limitation stating that the negative results do not preclude the possibility of central nervous system infection. (8) The device labeling must include a limitation stating that device results are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. (9) The device labeling must include a limitation stating that positive results do not mean that the organism detected is infectious or is the causative agent for clinical symptoms. (10) 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 13, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-22769 Filed 10-19-17; 8:45 am] BILLING CODE 4164-01-P
![48762 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Rules and Regulations
this requirement. As explained above, place the words ‘‘not less than $19,246 Administration, 10903 New Hampshire
the adjustments required for years and not more than $192,459.’’ Ave., Bldg. 66, Rm. 4524, Silver Spring,
subsequent to 2017 are not subject to the ■ b. In paragraph (e), remove the two MD, 20993–0002, 301–796–6679,
requirements of the Administrative occurrences of ‘‘$18,936’’ and add in kimberly.sconce@fda.hhs.gov.
Procedure Act. Moreover, the 2017 their place ‘‘$19,246’’ and remove SUPPLEMENTARY INFORMATION:
adjustments are made according to a ‘‘189,361’’ and add in its place
statutory formula that does not provide ‘‘$192,459’’. I. Background
for agency discretion. Accordingly, a Upon request, FDA has classified the
Appendix A to Part 1271 [Amended] device to detect and identify microbial
delay in effectiveness of the 2017
adjustments is not required. ■ 5. In appendix A to part 1271, in the pathogen nucleic acids in cerebrospinal
paragraph following paragraph (3) and fluid as class II (special controls), which
IV. Regulatory Requirements we have determined will provide a
in the last paragraph of the appendix,
Regulatory Flexibility Act remove the words ‘‘not less than reasonable assurance of safety and
$18,936 and not more than $189,361’’ effectiveness. In addition, we believe
Because no notice of proposed
and add in their place the words ‘‘not this action will enhance patients’ access
rulemaking is required, the Regulatory
less than $19,246 and not more than to beneficial innovation, in part by
Flexibility Act does not require an
$192,459’’. reducing regulatory burdens by placing
initial or final regulatory flexibility
the device into a lower device class than
analysis.9 Nanette J. Smith, the automatic class III assignment.
Paperwork Reduction Act NASA Federal Register Liaison Officer. The automatic assignment of class III
[FR Doc. 2017–22847 Filed 10–19–17; 8:45 am] occurs by operation of law and without
In accordance with the Paperwork
BILLING CODE P any action by FDA, regardless of the
Reduction Act of 1995,10 NASA
level of risk posed by the new device.
reviewed this interim final rule. No
Any device that was not in commercial
collections of information pursuant to
distribution before May 28, 1976, is
the Paperwork Reduction Act are DEPARTMENT OF HEALTH AND
automatically classified as, and remains
contained in the interim final rule. HUMAN SERVICES
within, class III and requires premarket
List of Subjects in 14 CFR Parts 1264 Food and Drug Administration approval unless and until FDA takes an
and 1271 action to classify or reclassify the device
Claims, Lobbying, Penalties. 21 CFR Part 866 (see 21 U.S.C. 360c(f)(1)). We refer to
these devices as ‘‘postamendments
For the reasons stated in the [Docket No. FDA–2017–N–5371] devices’’ because they were not in
preamble, the National Aeronautics and commercial distribution prior to the
Space Administration adopts as final Medical Devices; Immunology and date of enactment of the Medical Device
the interim rule amending 14 CFR parts Microbiology Devices; Classification of Amendments of 1976, which amended
1264 and 1271 which published on June the Device To Detect and Identify the Federal Food, Drug, and Cosmetic
26, 2017, at 82 FR 28760, with the Microbial Pathogen Nucleic Acids in Act (the FD&C Act).
following changes: Cerebrospinal Fluid FDA may take a variety of actions in
AGENCY: Food and Drug Administration, appropriate circumstances to classify or
PART 1264—IMPLEMENTATION OF
HHS. reclassify a device into class I or II. We
THE PROGRAM FRAUD CIVIL
may issue an order finding a new device
PENALTIES ACT OF 1986 ACTION: Final order. to be substantially equivalent under
■ 1. The authority citation for part 1264 SUMMARY: The Food and Drug section 513(i) of the FD&C Act (21
continues to read as follows: Administration (FDA or we) is U.S.C. 360c(i)) to a predicate device that
classifying the device to detect and does not require premarket approval.
Authority: 31 U.S.C. 3809, 51 U.S.C. We determine whether a new device is
20113(a). identify microbial pathogen nucleic
acids in cerebrospinal fluid into class II substantially equivalent to a predicate
§ 1264.102 [Amended] (special controls). The special controls by means of the procedures for
that will apply to the device type are premarket notification under section
■ 2. In § 1264.102, paragraphs (a) and
identified in this order and will be part 510(k) of the FD&C Act (21 U.S.C.
(b), remove the number ‘‘$10,781’’ and
of the codified language for the device 360(k)) and part 807 (21 CFR part 807).
add in its place the number ‘‘$10,957.’’ FDA may also classify a device
to detect and identify microbial
PART 1271—NEW RESTRICTIONS ON through ‘‘De Novo’’ classification, a
pathogen nucleic acids in cerebrospinal
LOBBYING common name for the process
fluid’s classification. We are taking this
authorized under section 513(f)(2) of the
action because we have determined that
■ 3. The authority citation for part 1271 FD&C Act. Section 207 of the Food and
classifying the device into class II
continues to read as follows: Drug Administration Modernization Act
(special controls) will provide a
Authority: Section 319, Pub. L. 101–121 of 1997 established the first procedure
reasonable assurance of safety and
(31 U.S.C. 1352); Pub. L. 97–258 (31 U.S.C. for De Novo classification (Pub. L. 105–
effectiveness of the device. We believe
6301 et seq.) 115). Section 607 of the Food and Drug
this action will also enhance patients’
Administration Safety and Innovation
§ 1271.400 [Amended] access to beneficial innovative devices,
Act modified the De Novo application
in part by reducing regulatory burdens.
nlaroche on DSK9F9SC42PROD with RULES
■4. In § 1271.400: process by adding a second procedure
■a. In paragraphs (a) and (b) remove the DATES: This order is effective October (Pub. L. 112–144). A device sponsor
words ‘‘not less than $18,936 and not 20, 2017. The classification was may utilize either procedure for De
more than $189,361’’ and add in their applicable on October 8, 2015. Novo classification.
FOR FURTHER INFORMATION CONTACT: Under the first procedure, the person
95 U.S.C. 603(a), 604(a). Kimberly Sconce, Center for Devices submits a 510(k) for a device that has
10 44 U.S.C. 3506. and Radiological Health, Food and Drug not previously been classified. After
VerDate Sep<11>2014 14:59 Oct 19, 2017 Jkt 244001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1](https://thefederalregister.org/doc/82_FR_48964/page/1.svg)
![48764 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Rules and Regulations
sequences from patients suspected of document an appropriate end user light and Annex I, paragraph 2(f)(i),
meningitis or encephalitis. A device to device training program that will be pertaining to the masthead light being
detect and identify microbial pathogen offered as part of your efforts to mitigate above and clear of all other lights and
nucleic acids in cerebrospinal fluid is the risk of failure to correctly operate obstructions; Rule 30 (a), Rule 21(e), and
intended to aid in the diagnosis of the instrument. Annex I, paragraph 2(k), pertaining to
meningitis or encephalitis when used in Dated: October 13, 2017. the vertical separation of the anchor
conjunction with clinical signs and Leslie Kux,
lights, vertical placement of the forward
symptoms and other clinical and anchor light above the hull, and the arc
Associate Commissioner for Policy.
laboratory findings. of visibility of all around lights; Rule 23
[FR Doc. 2017–22769 Filed 10–19–17; 8:45 am]
(b) Classification. Class II (special (a) and Annex I, paragraph 3(b),
controls). The special controls for this BILLING CODE 4164–01–P pertaining to the location of the
device are: sidelights; and Rule 21(c), pertaining to
(1) Premarket notification the location and arc of visibility of the
submissions must include detailed DEPARTMENT OF DEFENSE sternlight. The DAJAG (Admiralty and
device description documentation, Maritime Law) has also certified that the
including the device components, Department of the Navy lights involved are located in closest
ancillary reagents required but not possible compliance with the applicable
provided, and a detailed explanation of 32 CFR Part 706 72 COLREGS requirements.
the methodology, including primer/ Moreover, it has been determined, in
Certifications and Exemptions Under
probe sequence, design, and rationale accordance with 32 CFR parts 296 and
the International Regulations for
for sequence selection. 701, that publication of this amendment
(2) Premarket notification Preventing Collisions at Sea, 1972
for public comment prior to adoption is
submissions must include detailed AGENCY: Department of the Navy, DoD. impracticable, unnecessary, and
documentation from the following ACTION: Final rule. contrary to public interest since it is
analytical studies: Analytical sensitivity based on technical findings that the
(limit of detection), inclusivity, SUMMARY: The Department of the Navy placement of lights on these vessels in
reproducibility, interference, cross (DoN) is amending its certifications and a manner differently from that
reactivity, and specimen stability. exemptions under the International prescribed herein will adversely affect
(3) Premarket notification Regulations for Preventing Collisions at these vessels’ ability to perform their
submissions must include detailed Sea, 1972 (72 COLREGS), to reflect that military functions.
documentation from a clinical study. the Deputy Assistant Judge Advocate
The study, performed on a study General (DAJAG) (Admiralty and List of Subjects in 32 CFR Part 706
population consistent with the intended Maritime Law) has determined that Marine safety, Navigation (water),
use population, must compare the certain vessels of the VIRGINIA SSN Vessels.
device performance to results obtained Class are vessels of the Navy which, due For the reasons set forth in the
from well-accepted comparator to their special construction and preamble, the DoN amends part 706 of
methods. purpose, cannot fully comply with title 32 of the Code of Federal
(4) Premarket notification certain provisions of the 72 COLREGS Regulations as follows:
submissions must include detailed without interfering with their special
documentation for device software, function as a naval ships. The intended PART 706—CERTIFICATIONS AND
including, but not limited to, software effect of this rule is to warn mariners in EXEMPTIONS UNDER THE
applications and hardware-based waters where 72 COLREGS apply. INTERNATIONAL REGULATIONS FOR
devices that incorporate software. DATES: This rule is effective October 20, PREVENTING COLLISIONS AT SEA,
(5) The Intended Use statement in the 2017 and is applicable beginning 1972
device labeling must include a September 30, 2017.
statement that the device is intended to ■ 1. The authority citation for part 706
FOR FURTHER INFORMATION CONTACT:
be used in conjunction with standard of continues to read as follows:
care culture. Lieutenant Commander Kyle Fralick,
(Admiralty and Maritime Law), Office of Authority: 33 U.S.C. 1605.
(6) A detailed explanation of the
interpretation of results and acceptance the Judge Advocate General, Department ■ 2. Section 706.2 is amended by:
criteria must be included in the device’s of the Navy, 1322 Patterson Ave. SE., ■ a. In Table One, adding, in alpha
21 CFR 809.10(b)(9) compliant labeling. Suite 3000, Washington Navy Yard, DC numerical order, by vessel number, an
(7) The device labeling must include 20374–5066, telephone 202–685–5040. entry for USS INDIANA (SSN 789);
a limitation stating that the negative SUPPLEMENTARY INFORMATION: Pursuant ■ b. In Table Three, adding, in alpha
results do not preclude the possibility of to the authority granted in 33 U.S.C. numerical order, by vessel number, an
central nervous system infection. 1605, the DoN amends 32 CFR part 706. entry for USS INDIANA (SSN 789); and
(8) The device labeling must include This amendment provides notice that ■ c. In Table Four:
a limitation stating that device results the DAJAG (Admiralty and Maritime ■ i. In paragraph 25, adding, in alpha
are not intended to be used as the sole Law), under authority delegated by the numerical order, by vessel number, an
basis for diagnosis, treatment, or other Secretary of the Navy, has certified that entry for USS INDIANA (SSN 789); and
patient management decisions. certain vessels of the SSN Class are ■ ii. In paragraph 26, adding, in alpha
(9) The device labeling must include vessels of the Navy which, due to their numerical order, by vessel number, an
nlaroche on DSK9F9SC42PROD with RULES
a limitation stating that positive results special construction and purpose, entry for USS INDIANA (SSN 789).
do not mean that the organism detected cannot fully comply with the following The additions read as follows:
is infectious or is the causative agent for specific provisions of 72 COLREGS
clinical symptoms. without interfering with their special § 706.2 Certifications of the Secretary of
(10) As part of the risk management function as a naval ship: Rule 23(a) and the Navy under Executive Order 11964 and
activities performed as part of your 21 Annex I, paragraph 2(a)(i), pertaining to 33 U.S.C. 1605.
CFR 820.30 design controls, you must the vertical placement of the masthead, * * * * *
VerDate Sep<11>2014 14:59 Oct 19, 2017 Jkt 244001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\20OCR1.SGM 20OCR1](https://thefederalregister.org/doc/82_FR_48964/page/3.svg)
Document Created: 2017-10-20 00:06:04
Document Modified: 2017-10-20 00:06:04
| 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 20, 2017. The classification was applicable on October 8, 2015. | |
| Contact | Kimberly Sconce, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4524, Silver Spring, MD, 20993-0002, 301- 796-6679, [email protected] | |
| FR Citation | 82 FR 48762 | |
| CFR Associated | Biologics; Laboratories and Medical Devices |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR