83 FR 54873 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Insulin Therapy Adjustment Device
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 212 (November 1, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 212 (November 1, 2018)
| Page Range | 54873-54875 | |
| FR Document | 2018-23912 |
[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)] [Rules and Regulations] [Pages 54873-54875] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23912] [[Page 54873]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 862 [Docket No. FDA-2018-N-3648] Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Insulin Therapy Adjustment Device AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the insulin therapy adjustment device 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 insulin therapy adjustment device'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 November 1, 2018. The classification was applicable on June 12, 2018. FOR FURTHER INFORMATION CONTACT: Dina Jerebitski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301- 796-2411, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the insulin therapy adjustment device 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 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. 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 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 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 17, 2017, DreaMed Diabetes, Ltd., submitted a request for De Novo classification of the DreaMed Advisor Pro. 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 12, 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 862.1358. We have named the generic type of device insulin therapy adjustment device, and it is identified as a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus. 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. [[Page 54874]] Table 1--Insulin Therapy Adjustment Device Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Erroneous or extreme changes in insulin Special controls (1) (21 CFR dosing recommendations may cause 862.1358(b)(1)), (2) (21 CFR hypoglycemia or hyperglycemia. 862.1358(b)(2)), and (3) (21 CFR 862.1358(b)(3)). Incorrect interpretation of results may Special controls (1) (21 CFR lead to inappropriate clinical decision 862.1358(b)(1)) and (3) (21 making. CFR 862.1358(b)(3)). Incorrect understanding of appropriate Special controls (1) (21 CFR device use may lead to inappropriate 862.1358(b)(1)), (2) (21 CFR treatment decisions. 862.1358(b)(2)), and (3) (21 CFR 862.1358(b)(3)). Patient harm due to insecure Special control (1) (21 CFR transmission of data. 862.1358(b)(1)). Data corruption may lead to Special control (1) (21 CFR inappropriate treatment recommendations. 862.1358(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. 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 We have 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 21 CFR 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, regarding quality system regulations, 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 862 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 862 is amended as follows: PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES 0 1. The authority citation for part 862 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 862.1358 to subpart B to read as follows: Sec. 862.1358 Insulin therapy adjustment device. (a) Identification. An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus. (b) Classification. Class II (special controls). The special controls for this device are: (1) Design verification and validation must include the following: (i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations; (ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated; (iii) Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations; (iv) A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification; (v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures; (vi) Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device; and (vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level. (2) The device must not be intended for use in implementing automated insulin dosing. (3) Your 21 CFR 809.10(b) labeling must include: (i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device; (ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations; (iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device; and (iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel). [[Page 54875]] Dated: October 29, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-23912 Filed 10-31-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Rules and Regulations 54873
DEPARTMENT OF HEALTH AND approval unless and until FDA takes an We believe this De Novo classification
HUMAN SERVICES action to classify or reclassify the device will enhance patients’ access to
(see 21 U.S.C. 360c(f)(1)). We refer to beneficial innovation, in part by
Food and Drug Administration these devices as ‘‘postamendments reducing regulatory burdens. When FDA
devices’’ because they were not in classifies a device into class I or II via
21 CFR Part 862 commercial distribution prior to the the De Novo process, the device can
[Docket No. FDA–2018–N–3648] date of enactment of the Medical Device serve as a predicate for future devices of
Amendments of 1976, which amended that type, including for 510(k)s (see 21
Medical Devices; Clinical Chemistry the Federal Food, Drug, and Cosmetic U.S.C. 360c(f)(2)(B)(i)). As a result, other
and Clinical Toxicology Devices; Act (FD&C Act). device sponsors do not have to submit
Classification of the Insulin Therapy FDA may take a variety of actions in a De Novo request or premarket
Adjustment Device appropriate circumstances to classify or approval application to market a
reclassify a device into class I or II. We substantially equivalent device (see 21
AGENCY: Food and Drug Administration, U.S.C. 360c(i), defining ‘‘substantial
may issue an order finding a new device
HHS. equivalence’’). Instead, sponsors can use
to be substantially equivalent under
ACTION: Final order. section 513(i) of the FD&C Act (21 the less-burdensome 510(k) process,
SUMMARY: The Food and Drug U.S.C. 360c(i)) to a predicate device that when necessary, to market their device.
Administration (FDA or we) is does not require premarket approval. II. De Novo Classification
classifying the insulin therapy We determine whether a new device is
adjustment device into class II (special substantially equivalent to a predicate On August 17, 2017, DreaMed
controls). The special controls that by means of the procedures for Diabetes, Ltd., submitted a request for
apply to the device type are identified premarket notification under section De Novo classification of the DreaMed
in this order and will be part of the 510(k) of the FD&C Act (21 U.S.C. Advisor Pro. FDA reviewed the request
codified language for the insulin 360(k)) and part 807 (21 CFR part 807). in order to classify the device under the
therapy adjustment device’s FDA may also classify a device criteria for classification set forth in
classification. We are taking this action through ‘‘De Novo’’ classification, a section 513(a)(1) of the FD&C Act.
because we have determined that common name for the process We classify devices into class II if
classifying the device into class II authorized under section 513(f)(2) of the general controls by themselves are
(special controls) will provide a FD&C Act. Section 207 of the Food and insufficient to provide reasonable
reasonable assurance of safety and Drug Administration Modernization Act assurance of safety and effectiveness,
effectiveness of the device. We believe of 1997 (Pub. L. 105–115) established but there is sufficient information to
this action will also enhance patients’ the first procedure for De Novo establish special controls that, in
access to beneficial innovative devices, classification. Section 607 of the Food combination with the general controls,
in part by reducing regulatory burdens. and Drug Administration Safety and provide reasonable assurance of the
DATES: This order is effective November Innovation Act (Pub. L. 112–144) safety and effectiveness of the device for
1, 2018. The classification was modified the De Novo application its intended use (see 21 U.S.C.
applicable on June 12, 2018. process by adding a second procedure. 360c(a)(1)(B)). After review of the
FOR FURTHER INFORMATION CONTACT: Dina
A device sponsor may utilize either information submitted in the request,
Jerebitski, Center for Devices and procedure for De Novo classification. we determined that the device can be
Radiological Health, Food and Drug Under the first procedure, the person classified into class II with the
Administration, 10903 New Hampshire submits a 510(k) for a device that has establishment of special controls. FDA
Ave., Bldg. 66, Rm. 4550, Silver Spring, not previously been classified. After has determined that these special
MD 20993–0002, 301–796–2411, receiving an order from FDA classifying controls, in addition to the general
Dina.Jerebitski@fda.hhs.gov. the device into class III under section controls, will provide reasonable
513(f)(1) of the FD&C Act, the person assurance of the safety and effectiveness
SUPPLEMENTARY INFORMATION:
then requests a classification under of the device.
I. Background section 513(f)(2). Therefore, on June 12, 2018, FDA
Upon request, FDA has classified the Under the second procedure, rather issued an order to the requester
insulin therapy adjustment device as than first submitting a 510(k) and then classifying the device into class II. FDA
class II (special controls), which we a request for classification, if the person is codifying the classification of the
have determined will provide a determines that there is no legally device by adding 21 CFR 862.1358. We
reasonable assurance of safety and marketed device upon which to base a have named the generic type of device
effectiveness. In addition, we believe determination of substantial insulin therapy adjustment device, and
this action will enhance patients’ access equivalence, that person requests a it is identified as a device intended to
to beneficial innovation, in part by classification under section 513(f)(2) of incorporate biological inputs, including
reducing regulatory burdens by placing the FD&C Act. glucose measurement data from a
the device into a lower device class than Under either procedure for De Novo continuous glucose monitor, to
the automatic class III assignment. classification, FDA is required to recommend insulin therapy adjustments
The automatic assignment of class III classify the device by written order as an aid in optimizing insulin therapy
occurs by operation of law and without within 120 days. The classification will regimens for patients with diabetes
any action by FDA, regardless of the be according to the criteria under mellitus.
amozie on DSK3GDR082PROD with RULES
level of risk posed by the new device. section 513(a)(1) of the FD&C Act. FDA has identified the following risks
Any device that was not in commercial Although the device was automatically to health associated specifically with
distribution before May 28, 1976, is placed within class III, the De Novo this type of device and the measures
automatically classified as, and remains classification is considered to be the required to mitigate these risks in Table
within, class III and requires premarket initial classification of the device. 1.
VerDate Sep<11>2014 20:21 Oct 31, 2018 Jkt 247001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\01NOR1.SGM 01NOR1](https://thefederalregister.org/doc/83_FR_55085/page/1.svg)
![Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Rules and Regulations 54875
Dated: October 29, 2018. level of risk posed by the new device. to be the initial classification of the
Leslie Kux, Any device that was not in commercial device.
Associate Commissioner for Policy. distribution before May 28, 1976, is We believe this De Novo classification
[FR Doc. 2018–23912 Filed 10–31–18; 8:45 am] 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 reducing regulatory burdens. When FDA
action to classify or reclassify the device classifies a device into class I or II via
DEPARTMENT OF HEALTH AND (see 21 U.S.C. 360c(f)(1)). We refer to the De Novo process, the device can
HUMAN SERVICES these devices as ‘‘postamendments serve as a predicate for future devices of
devices’’ because they were not in that type, including for 510(k)s (see 21
Food and Drug Administration commercial distribution prior to the U.S.C. 360c(f)(2)(B)(i)). As a result, other
date of enactment of the Medical Device device sponsors do not have to submit
21 CFR Part 862 Amendments of 1976, which amended a De Novo request or premarket
the Federal Food, Drug, and Cosmetic approval application to market a
[Docket No. FDA–2018–N–3694]
Act (FD&C Act). substantially equivalent device (see 21
Medical Devices; Clinical Chemistry FDA may take a variety of actions in U.S.C. 360c(i), defining ‘‘substantial
and Clinical Toxicology Devices; appropriate circumstances to classify or equivalence’’). Instead, sponsors can use
Classification of the Meprobamate Test reclassify a device into class I or II. We the less-burdensome 510(k) process,
System may issue an order finding a new device when necessary, to market their device.
to be substantially equivalent under
AGENCY: Food and Drug Administration, section 513(i) of the FD&C Act (21 II. De Novo Classification
HHS. U.S.C. 360c(i)) to a predicate device that On February 21, 2017, Lin-Zhi
ACTION: Final order. does not require premarket approval. International, Inc. submitted a request
We determine whether a new device is for De Novo classification of the LZI
SUMMARY: The Food and Drug substantially equivalent to a predicate Carisoprodol Metabolite (Meprobamate)
Administration (FDA or we) is by means of the procedures for Enzyme Immunoassay. FDA reviewed
classifying the meprobamate test system premarket notification under section the request in order to classify the
into class II (special controls). The 510(k) of the FD&C Act (21 U.S.C. device under the criteria for
special controls that apply to the device 360(k)) and part 807 (21 CFR part 807). classification set forth in section
type are identified in this order and will FDA may also classify a device 513(a)(1) of the FD&C Act.
be part of the codified language for the through ‘‘De Novo’’ classification, a
We classify devices into class II if
meprobamate test system’s common name for the process
general controls by themselves are
classification. We are taking this action authorized under section 513(f)(2) of the
insufficient to provide reasonable
because we have determined that FD&C Act. Section 207 of the Food and
Drug Administration Modernization Act assurance of safety and effectiveness,
classifying the device into class II but there is sufficient information to
(special controls) will provide a of 1997 (Pub. L. 105–115) established
the first procedure for De Novo establish special controls that, in
reasonable assurance of safety and combination with the general controls,
effectiveness of the device. We believe classification. Section 607 of the Food
and Drug Administration Safety and provide reasonable assurance of the
this action will also enhance patients’ safety and effectiveness of the device for
access to beneficial innovative devices, Innovation Act (Pub. L. 112–144)
modified the De Novo application its intended use (see 21 U.S.C.
in part by reducing regulatory burdens. 360c(a)(1)(B)). After review of the
process by adding a second procedure.
DATES: This order is effective November information submitted in the request,
A device sponsor may utilize either
1, 2018. The classification was we determined that the device can be
procedure for De Novo classification.
applicable on April 20, 2018. classified into class II with the
Under the first procedure, the person
FOR FURTHER INFORMATION CONTACT: submits a 510(k) for a device that has establishment of special controls. FDA
Ryan Lubert, Center for Devices and not previously been classified. After has determined that these special
Radiological Health, Food and Drug receiving an order from FDA classifying controls, in addition to the general
Administration, 10903 New Hampshire the device into class III under section controls, will provide reasonable
Ave., Bldg. 66, Rm. 4545, Silver Spring, 513(f)(1) of the FD&C Act, the person assurance of the safety and effectiveness
MD 20993–0002, 240–402–6357, then requests a classification under of the device.
Ryan.Lubert@fda.hhs.gov. section 513(f)(2). Therefore, on April 20, 2018, FDA
SUPPLEMENTARY INFORMATION: Under the second procedure, rather issued an order to the requester
than first submitting a 510(k) and then classifying the device into class II. FDA
I. Background is codifying the classification of the
a request for classification, if the person
Upon request, FDA has classified the determines that there is no legally device by adding 21 CFR 862.3590. We
meprobamate test system as class II marketed device upon which to base a have named the generic type of device
(special controls), which we have determination of substantial meprobamate test system, and it is
determined will provide a reasonable equivalence, that person requests a identified as a device intended to
assurance of safety and effectiveness. In classification under section 513(f)(2) of measure meprobamate in human
addition, we believe this action will the FD&C Act. specimens. Measurements obtained by
enhance patients’ access to beneficial Under either procedure for De Novo this device are used to detect the
innovation, in part by reducing classification, FDA shall classify the presence of meprobamate to diagnose
amozie on DSK3GDR082PROD with RULES
regulatory burdens by placing the device by written order within 120 days. the use or overdose of meprobamate or
device into a lower device class than the The classification will be according to structurally-related drug compounds
automatic class III assignment. the criteria under section 513(a)(1) of (e.g., prodrugs).
The automatic assignment of class III the FD&C Act. Although the device was FDA has identified the following risks
occurs by operation of law and without automatically placed within class III, to health associated specifically with
any action by FDA, regardless of the the De Novo classification is considered this type of device and the measures
VerDate Sep<11>2014 20:21 Oct 31, 2018 Jkt 247001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\01NOR1.SGM 01NOR1](https://thefederalregister.org/doc/83_FR_55085/page/3.svg)
Document Created: 2018-11-01 01:05:35
Document Modified: 2018-11-01 01:05:35
| 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 November 1, 2018. The classification was applicable on June 12, 2018. | |
| Contact | Dina Jerebitski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301- 796-2411, [email protected] | |
| FR Citation | 83 FR 54873 |
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