Source: https://regulations.justia.com/regulations/fedreg/2018/11/01/2018-23912.html
Timestamp: 2019-06-16 13:08:17
Document Index: 493042398

Matched Legal Cases: ['art 862', 'art 807', 'art 807', 'arts 801', 'ART 862', 'art 814', 'art 807', 'art 820', 'art 862', 'art 862', 'art 862', '§ 862', '§ 862', 'art 862', 'art 807', 'art 807', 'art 820', 'arts 801']

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Insulin Therapy Adjustment Device, 54873-54875 [2018-23912] :: Food And Drug Administration :: Department Of Health And Human Services :: Regulation Tracker :: Justia
Justia Regulation Tracker Department Of Health And Human Services Food And Drug Administration Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Insulin Therapy Adjustment Device, 54873-54875 [2018-23912]
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Insulin Therapy Adjustment Device, 54873-54875 [2018-23912]
Download as PDF Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Rules and Regulations 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. 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, Dina.Jerebitski@fda.hhs.gov. SUPPLEMENTARY INFORMATION: amozie on DSK3GDR082PROD with RULES SUMMARY: 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 VerDate Sep<11>2014 20:21 Oct 31, 2018 Jkt 247001 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. PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 54873 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. E:\FR\FM\01NOR1.SGM 01NOR1 54874 Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Rules and Regulations TABLE 1—INSULIN THERAPY ADJUSTMENT DEVICE RISKS AND MITIGATION MEASURES Identified risks Mitigation measures Erroneous or extreme changes in insulin dosing recommendations may cause hypoglycemia or hyperglycemia. Special controls (1) (21 CFR 862.1358(b)(1)), (2) (21 CFR 862.1358(b)(2)), and (3) (21 CFR 862.1358(b)(3)). Special controls (1) (21 CFR 862.1358(b)(1)) and (3) (21 CFR 862.1358(b)(3)). Special controls (1) (21 CFR 862.1358(b)(1)), (2) (21 CFR 862.1358(b)(2)), and (3) (21 CFR 862.1358(b)(3)). Special control (1) (21 CFR 862.1358(b)(1)). Special control (1) (21 CFR 862.1358(b)(1)). Incorrect interpretation of results may lead to inappropriate clinical decision making ... Incorrect understanding of appropriate device use may lead to inappropriate treatment decisions. Patient harm due to insecure transmission of data ......................................................... Data corruption may lead to inappropriate treatment recommendations ........................ 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. 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. III. Analysis of Environmental Impact PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES 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. amozie on DSK3GDR082PROD with RULES 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 VerDate Sep<11>2014 20:21 Oct 31, 2018 Jkt 247001 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: 1. The authority citation for part 862 continues to read as follows: ■ Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 2. Add § 862.1358 to subpart B to read as follows: ■ § 862.1358 device. Insulin therapy adjustment (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; PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 (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). E:\FR\FM\01NOR1.SGM 01NOR1 Federal Register / Vol. 83, No. 212 / Thursday, November 1, 2018 / Rules and Regulations 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 862 [Docket No. FDA–2018–N–3694] Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Meprobamate Test System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. The Food and Drug Administration (FDA or we) is classifying the meprobamate test system 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 meprobamate test system’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 April 20, 2018. 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, Ryan.Lubert@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: amozie on DSK3GDR082PROD with RULES I. Background Upon request, FDA has classified the meprobamate test system 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 VerDate Sep<11>2014 20:21 Oct 31, 2018 Jkt 247001 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 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 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 54875 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 February 21, 2017, Lin-Zhi International, Inc. submitted a request for De Novo classification of the LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay. 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 April 20, 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 862.3590. We have named the generic type of device meprobamate test system, and it is identified as a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally-related drug compounds (e.g., prodrugs). FDA has identified the following risks to health associated specifically with this type of device and the measures E:\FR\FM\01NOR1.SGM 01NOR1
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[FR Doc No: 2018-23912]
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[Docket No. FDA-2018-N-3648]
Devices; Classification of the Insulin Therapy Adjustment Device
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
FOR FURTHER INFORMATION CONTACT: Dina Jerebitski, Center for Devices
Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-
796-2411, [email protected].
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
On August 17, 2017, DreaMed Diabetes, Ltd., submitted a request for
De Novo classification of the DreaMed Advisor Pro. FDA reviewed the
Therefore, on June 12, 2018, FDA issued an order to the requester
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.
[[Page 54874]]
Table 1--Insulin Therapy Adjustment Device Risks and 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
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)).
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
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.
(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
(2) The device must not be intended for use in implementing
automated insulin dosing.
(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;
(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]]