82 FR 47969 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Enzyme Packed Cartridge
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 | 47969-47971 | |
| FR Document | 2017-22286 |
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)] [Rules and Regulations] [Pages 47969-47971] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22286] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 876 [Docket No. FDA-2017-N-5224] Medical Devices; Gastroenterology-Urology Devices; Classification of the Enzyme Packed Cartridge AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the enzyme packed cartridge 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 enzyme packed cartridge'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 16, 2017. The classification was applicable on November 20, 2015. FOR FURTHER INFORMATION CONTACT: Joshua Silverstein, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD, 20993-0002, 301- 796-5155, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the enzyme packed cartridge as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In [[Page 47970]] 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 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 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 January 2, 2015, Alcresta, Inc. submitted a request for De Novo classification of the RELIZORBTM. 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 November 20, 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 876.5985. We have named the generic type of device enzyme packed cartridge, and it is identified as an ex vivo prescription device that is used in enzymatic hydrolysis of macronutrients into their essential nutrient forms at the time of delivery. The device consists of an outer casing containing an inert polymer with a covalently bound enzyme through which nutritional formula is directed. The device fits in line with enteral feeding systems. 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--Enzyme Packed Cartridge Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Adverse tissue reaction................ Biocompatibility testing, Non- clinical testing, In vivo testing, and Labeling. Mechanical failure..................... Non-clinical testing, Shelf life testing, and Labeling.Deprivation of care....... Device clogging........... Filter becomes dislodged and releases beads into enteral formula. Reduced enzymatic effect............... Non-clinical testing, In vivo testing, Shelf life testing, and Labeling. Use error.............................. Human factors testing and Labeling. Infection.............................. Shelf life testing and Labeling. ------------------------------------------------------------------------ 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 [[Page 47971]] 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). At the time of classification, enzyme packed cartridges are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met. 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 administrative 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, and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 876 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 876 is amended as follows: PART 876--GASTROENTEROLOGY-UROLOGY DEVICES 0 1. The authority citation for part 876 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 876.5985 to subpart F to read as follows: Sec. 876.5985 Enzyme packed cartridge. (a) Identification. An enzyme packed cartridge is an ex vivo prescription device that is used in enzymatic hydrolysis of macronutrients into their essential nutrient forms at the time of delivery. The device consists of an outer casing containing an inert polymer with a covalently bound enzyme through which nutritional formula is directed. The device fits in line with enteral feeding systems. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient contacting components of the device must be demonstrated to be biocompatible. (2) In vivo testing must be performed and must demonstrate that the device causes neither an adverse tissue response nor adverse performance. (3) Non-clinical testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated: (i) Mechanical testing to demonstrate that the device can withstand clinical forces; (ii) Flow rate and leakage testing to demonstrate that the device does not impede the flow of enteral formula; (iii) Demonstration of enzymatic effect on intended macronutrient; (iv) The amount of enzyme that exits the cartridge must be characterized; (v) Validation that the device does not adversely impact the nutritional composition of enteral formula; and (vi) Validation that the device does not impede flow alarms on enteral feeding pumps. (4) Human factors testing must be performed to characterize use error risks. (5) Performance data must support shelf life by demonstrating package integrity and device functionality over the identified shelf life. (6) Labeling must include the following: (i) A detailed summary of in vivo testing pertinent to use of the device, including device-related adverse events; (ii) A detailed summary of compatible formulas that is supported by non-clinical testing, including the expected enzymatic conversion as a percentage; (iii) Detailed instructions on how to place the device into an enteral feeding circuit; (iv) A warning regarding the possibility for misconnections; and (v) Expiration date or shelf life. (7) Patient labeling must be provided and must include: (i) Relevant warnings, precautions, adverse effects, and complications; (ii) A description of the device and how it operates; (iii) Instructions on how to correctly use the device; and (iv) The benefits and risks associated with the use of the device. Dated: October 10, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-22286 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 47969
nor an environmental impact statement colony characteristics and enumerate (i) Conduct human factors/usability
is required. colonies from image capture through validation testing with the final version
end result. of the labeling and related materials to
IV. Paperwork Reduction Act of 1995 (2) Premarket notification adequately mitigate the risk of failure to
This final order establishes special submissions must include detailed operate the instrument correctly.
controls that refer to previously documentation of the analytical studies (ii) Document a device training
approved collections of information performed to characterize device program that will be offered to the end
found in other FDA regulations. These performance to support the intended user to adequately mitigate the risk of
collections of information are subject to use, as appropriate. failure to operate the instrument
review by the Office of Management and (3) Premarket notification correctly.
Budget (OMB) under the Paperwork submissions must include detailed Dated: October 11, 2017.
Reduction Act of 1995 (44 U.S.C. 3501– documentation from clinical studies
Leslie Kux,
3520). The collections of information in performed on a population that is
part 807, subpart E, regarding premarket Associate Commissioner for Policy.
consistent with the intended use
notification submissions have been population. [FR Doc. 2017–22305 Filed 10–13–17; 8:45 am]
approved under OMB control number (i) The clinical studies must establish BILLING CODE 4164–01–P
0910–0120, the collections of the device performance based on
information in part 820 have been comparison to results obtained by an
approved under OMB control number acceptable reference method, as DEPARTMENT OF HEALTH AND
0910–0073, and the collections of appropriate. HUMAN SERVICES
information in 21 CFR parts 801 and (ii) The clinical study documentation
must include the study protocol with a Food and Drug Administration
809, regarding labeling have been
approved under OMB control number predefined statistical analysis plan and
the final report documenting support for 21 CFR Part 876
0910–0485.
the Indications for Use and the results [Docket No. FDA–2017–N–5224]
List of Subjects in 21 CFR Part 866 of the statistical analysis, as appropriate.
Biologics, Laboratories, Medical (4) Premarket notification Medical Devices; Gastroenterology-
devices. submissions must include detailed Urology Devices; Classification of the
Therefore, under the Federal Food, documentation for device software, Enzyme Packed Cartridge
Drug, and Cosmetic Act and under including but not limited to software AGENCY: Food and Drug Administration,
authority delegated to the Commissioner applications and hardware based HHS.
of Food and Drugs, 21 CFR part 866 is components that incorporate software,
and any decision-making thresholds ACTION: Final order.
amended as follows:
used to generate results for the device. SUMMARY: The Food and Drug
PART 866—IMMUNOLOGY AND If a part of a Total Laboratory Administration (FDA or we) is
MICROBIOLOGY DEVICES Automation System, the premarket classifying the enzyme packed cartridge
notification submission must include into class II (special controls). The
■ 1. The authority citation for part 866 detailed documentation addressing the
continues to read as follows: special controls that apply to the device
instrument and software system type are identified in this order and will
Authority: 21 U.S.C. 351, 360, 360c, 360e, integration. be part of the codified language for the
360j, 360l, 371. (5) Premarket notification enzyme packed cartridge’s
■ 2. Add § 866.2190 to subpart C to read submissions must include detailed classification. We are taking this action
as follows: documentation of appropriate because we have determined that
instructions for use regarding the classifying the device into class II
§ 866.2190 Automated image assessment intended user’s device quality control
system for microbial colonies on solid
(special controls) will provide a
procedures for the instrument system reasonable assurance of safety and
culture media. and components, as appropriate.
(a) Identification. An automated effectiveness of the device. We believe
(6) The 21 CFR 809.10 compliant this action will also enhance patients’
image assessment system for microbial device labeling must include:
colonies on solid culture media is a access to beneficial innovative devices,
(i) Detailed user instructions to
system that is intended to assess the in part by reducing regulatory burdens.
mitigate the risk of failure to operate the
presence or absence of microbial DATES: This order is effective October
instrument correctly.
colonies on solid microbiological (ii) A detailed explanation of the 16, 2017. The classification was
culture medium, and to interpret their interpretation of results and limitations applicable on November 20, 2015.
number, and phenotypic and regarding the need for review of culture FOR FURTHER INFORMATION CONTACT:
morphologic characteristics through plates by a qualified microbiologist, as Joshua Silverstein, Center for Devices
analysis of two dimensional digital appropriate. and Radiological Health, Food and Drug
images as an aid in diagnosis of (iii) A summary of performance data Administration, 10903 New Hampshire
infectious disease. obtained from the analytical studies Ave., Bldg. 66, Rm. 1615, Silver Spring,
(b) Classification. Class II (special used to support device performance, as MD, 20993–0002, 301–796–5155,
controls). The special controls for this appropriate. joshua.silverstein@fda.hhs.gov.
device are: (iv) A summary of performance data SUPPLEMENTARY INFORMATION:
jstallworth on DSKBBY8HB2PROD with RULES
(1) Premarket notification obtained from clinical studies
submissions must include a detailed performed on a population that is I. Background
description of the device, including the consistent with the intended use Upon request, FDA has classified the
technology employed, components and population, as appropriate. enzyme packed cartridge as class II
software modules, as well as a detailed (7) Under 21 CFR 820.30 compliant (special controls), which we have
explanation of the result algorithms and design control, device manufacturers determined will provide a reasonable
any expert rules that are used to assess must, as appropriate: assurance of safety and effectiveness. In
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![Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 47971
final order. The necessary special casing containing an inert polymer with Dated: October 10, 2017.
controls appear in the regulation a covalently bound enzyme through Anna K. Abram,
codified by this order. This device is which nutritional formula is directed. Deputy Commissioner for Policy, Planning,
subject to premarket notification The device fits in line with enteral Legislation, and Analysis.
requirements under section 510(k). feeding systems. [FR Doc. 2017–22286 Filed 10–13–17; 8:45 am]
At the time of classification, enzyme (b) Classification. Class II (special BILLING CODE 4164–01–P
packed cartridges are for prescription controls). The special controls for this
use only. Prescription devices are device are:
exempt from the requirement for (1) The patient contacting DEPARTMENT OF JUSTICE
adequate directions for use for the components of the device must be
layperson under section 502(f)(1) of the demonstrated to be biocompatible. Drug Enforcement Administration
FD&C Act (21 U.S.C. 352(f)(1)) and 21 (2) In vivo testing must be performed
CFR 801.5, as long as the conditions of and must demonstrate that the device 21 CFR Part 1308
21 CFR 801.109 are met. causes neither an adverse tissue
[Docket No. DEA–402]
III. Analysis of Environmental Impact response nor adverse performance.
(3) Non-clinical testing must Schedules of Controlled Substances:
The Agency has determined under 21 demonstrate that the device performs as
CFR 25.34(b) that this action is of a type Placement of AB-CHMINACA, AB-
intended under anticipated conditions PINACA and THJ-2201 Into Schedule I
that does not individually or of use. The following performance
cumulatively have a significant effect on characteristics must be demonstrated: AGENCY: Drug Enforcement
the human environment. Therefore, (i) Mechanical testing to demonstrate Administration, Department of Justice.
neither an environmental assessment that the device can withstand clinical ACTION: Final rule.
nor an environmental impact statement forces;
is required. SUMMARY: With the issuance of this final
(ii) Flow rate and leakage testing to
IV. Paperwork Reduction Act of 1995 demonstrate that the device does not rule, the Drug Enforcement
impede the flow of enteral formula; Administration places N-(1-amino-3-
This final administrative order methyl-1-oxobutan-2-yl)-1-
establishes special controls that refer to (iii) Demonstration of enzymatic effect
on intended macronutrient; (cyclohexylmethyl)-1H-indazole-3-
previously approved collections of carboxamide (AB-CHMINACA), N-(1-
information found in other FDA (iv) The amount of enzyme that exits
the cartridge must be characterized; amino-3-methyl-1-oxobutan-2-yl)-1-
regulations. These collections of pentyl-1H-indazole-3-carboxamide (AB-
information are subject to review by the (v) Validation that the device does not
adversely impact the nutritional PINACA), and [1-(5-fluoropentyl)-1H-
Office of Management and Budget indazol-3-yl](naphthalen-1-
(OMB) under the Paperwork Reduction composition of enteral formula; and
(vi) Validation that the device does yl)methanone (THJ-2201), including
Act of 1995 (44 U.S.C. 3501–3520). The their salts, isomers, and salts of isomers
collections of information in part 807, not impede flow alarms on enteral
feeding pumps. whenever the existence of such salts,
subpart E, regarding premarket isomers, and salts of isomers is possible,
notification submissions have been (4) Human factors testing must be
performed to characterize use error into schedule I of the Controlled
approved under OMB control number Substances Act. This scheduling action
0910–0120, and the collections of risks.
(5) Performance data must support is pursuant to the Controlled Substances
information in 21 CFR part 801, Act which requires that such actions be
regarding labeling, have been approved shelf life by demonstrating package
integrity and device functionality over made on the record after opportunity for
under OMB control number 0910–0485. a hearing through formal rulemaking.
the identified shelf life.
List of Subjects in 21 CFR Part 876 (6) Labeling must include the This rule continues the imposition of
Medical devices. following: the regulatory controls and
(i) A detailed summary of in vivo administrative, civil, and criminal
Therefore, under the Federal Food,
testing pertinent to use of the device, sanctions applicable to schedule I
Drug, and Cosmetic Act and under
including device-related adverse events; controlled substances on persons who
authority delegated to the Commissioner
(ii) A detailed summary of compatible handle (manufacture, distribute, import,
of Food and Drugs, 21 CFR part 876 is
formulas that is supported by non- export, engage in research, conduct
amended as follows:
clinical testing, including the expected instructional activities or chemical
PART 876—GASTROENTEROLOGY- enzymatic conversion as a percentage; analysis, or possess), or propose to
UROLOGY DEVICES (iii) Detailed instructions on how to handle AB-CHMINACA, AB-PINACA
place the device into an enteral feeding and THJ-2201.
■ 1. The authority citation for part 876 circuit; DATES: Effective October 16, 2017.
continues to read as follows: (iv) A warning regarding the FOR FURTHER INFORMATION CONTACT:
Authority: 21 U.S.C. 351, 360, 360c, 360e, possibility for misconnections; and Michael J. Lewis, Diversion Control
360j, 360l, 371. (v) Expiration date or shelf life. Division, Drug Enforcement
■ 2. Add § 876.5985 to subpart F to read (7) Patient labeling must be provided Administration; Mailing Address: 8701
as follows: and must include: Morrissette Drive, Springfield, Virginia
(i) Relevant warnings, precautions, 22152; Telephone: (202) 598–6812.
jstallworth on DSKBBY8HB2PROD with RULES
§ 876.5985 Enzyme packed cartridge. adverse effects, and complications; SUPPLEMENTARY INFORMATION:
(a) Identification. An enzyme packed (ii) A description of the device and
cartridge is an ex vivo prescription how it operates; Legal Authority
device that is used in enzymatic (iii) Instructions on how to correctly Under the Controlled Substances Act
hydrolysis of macronutrients into their use the device; and (CSA), each controlled substance is
essential nutrient forms at the time of (iv) The benefits and risks associated classified into one of five schedules
delivery. The device consists of an outer with the use of the device. based upon its potential for abuse, its
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Document Created: 2017-10-14 01:42:19
Document Modified: 2017-10-14 01:42:19
| 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 November 20, 2015. | |
| Contact | Joshua Silverstein, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD, 20993-0002, 301- 796-5155, [email protected] | |
| FR Citation | 82 FR 47969 |
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