83 FR 52970 - Medical Devices; General and Plastic Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 203 (October 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 203 (October 19, 2018)
| Page Range | 52970-52972 | |
| FR Document | 2018-22784 |
[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)] [Rules and Regulations] [Pages 52970-52972] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22784] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2018-N-3595] Medical Devices; General and Plastic Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the hemostatic device for intraluminal gastrointestinal use 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 hemostatic device for intraluminal gastrointestinal use'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 19, 2018. The classification was applicable on May 7, 2018. FOR FURTHER INFORMATION CONTACT: Maegen Colehour, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G423, Silver Spring, MD, 20993-0002, 301- 796-6436, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the hemostatic device for intraluminal gastrointestinal use 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 March 9, 2017, Wilson-Cook Medical, Inc. submitted a request for De Novo classification of the Hemospray[supreg] Endoscopic Hemostat. 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 May 7, 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 878.4456. We have named the generic type of device hemostatic device for intraluminal gastrointestinal use, and it is identified as a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other means. FDA has identified the following risks to health associated specifically with this type of device and the measures [[Page 52971]] required to mitigate these risks in table 1. Table 1--Hemostatic Device for Intraluminal Gastrointestinal Use Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Bleeding:Inability to achieve In vivo performance testing, Non- hemostasis clinical performance testing, Recurrence of bleeding.. and Labeling. Infection............................ Sterilization validation, Shelf life testing, and Labeling. Adverse tissue reaction.............. In vivo performance testing, Non- clinical performance testing, Biocompatibility evaluation, and Labeling. Obstruction of gastrointestinal (GI) In vivo performance testing and tract. Labeling. GI distension or perforation......... In vivo performance testing and Labeling. Vascular obstruction: Ischemia In vivo performance testing, Non- Emboli formation........ clinical performance testing, and Labeling. Tissue trauma........................ In vivo performance testing, Non- clinical performance testing, and Labeling. Improper device use.................. In vivo performance 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. 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. We encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act. At the time of classification, hemostatic devices for intraluminal gastrointestinal use 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 (referring to 21 U.S.C. 352(f)(1)). 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 820, regarding quality system regulations, have been approved under OMB control number 0910-0073; 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 878 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 878 is amended as follows: PART 878--GENERAL AND PLASTIC SURGERY DEVICES 0 1. The authority citation for part 878 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 878.4456 to subpart E to read as follows: Sec. 878.4456 Hemostatic device for intraluminal gastrointestinal use. (a) Identification. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means. (b) Classification. Class II (special controls). The special controls for this device are: (1) The device must be demonstrated to be biocompatible. (2) Performance data must support the sterility and pyrogenicity of the device. (3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (4) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The testing must evaluate the following: (i) The ability to deliver the hemostatic material to the bleeding site; (ii) The ability to achieve hemostasis in a clinically relevant model of gastrointestinal bleeding; and (iii) Safety endpoints, including thromboembolic events, local and systemic toxicity, tissue trauma, gastrointestinal tract obstruction, and bowel distension and perforation. (5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Materials characterization of all components must demonstrate the device meets established specifications, which must include compositional identity and purity, characterization of [[Page 52972]] impurities, physical characteristics, and reactivity with fluids. (ii) Performance testing must demonstrate the mechanical integrity and functionality of the system used to deliver the device and demonstrate the device meets established specifications, including output pressure for propellant-based systems. (6) Labeling must include: (i) Information identifying and explaining how to use the device and its components; and (ii) A shelf life. Dated: October 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22784 Filed 10-18-18; 8:45 am] BILLING CODE 4164-01-P
![52970 Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations
Dated: October 15, 2018. The automatic assignment of class III section 513(a)(1) of the FD&C Act.
Leslie Kux, occurs by operation of law and without Although the device was automatically
Associate Commissioner for Policy. any action by FDA, regardless of the placed within class III, the De Novo
[FR Doc. 2018–22786 Filed 10–18–18; 8:45 am] level of risk posed by the new device. classification is considered to be the
BILLING CODE 4164–01–P
Any device that was not in commercial initial classification of the device.
distribution before May 28, 1976, is We believe this De Novo classification
automatically classified as, and remains will enhance patients’ access to
DEPARTMENT OF HEALTH AND within, class III and requires premarket beneficial innovation, in part by
HUMAN SERVICES 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
Food and Drug Administration (see 21 U.S.C. 360c(f)(1)). We refer to the De Novo process, the device can
these devices as ‘‘postamendments serve as a predicate for future devices of
21 CFR Part 878 devices’’ because they were not in that type, including for 510(k)s (see 21
commercial distribution prior to the U.S.C. 360c(f)(2)(B)(i)). As a result, other
[Docket No. FDA–2018–N–3595]
date of enactment of the Medical Device device sponsors do not have to submit
Medical Devices; General and Plastic Amendments of 1976, which amended a De Novo request or premarket
Surgery Devices; Classification of the the Federal Food, Drug, and Cosmetic approval application to market a
Hemostatic Device for Intraluminal Act (FD&C Act). substantially equivalent device (see 21
Gastrointestinal Use FDA may take a variety of actions in U.S.C. 360c(i), defining ‘‘substantial
appropriate circumstances to classify or equivalence’’). Instead, sponsors can use
AGENCY: Food and Drug Administration, reclassify a device into class I or II. We the less-burdensome 510(k) process,
HHS. may issue an order finding a new device when necessary, to market their device.
ACTION: Final order. to be substantially equivalent under
section 513(i) of the FD&C Act (21 II. De Novo Classification
SUMMARY: The Food and Drug U.S.C. 360c(i)) to a predicate device that On March 9, 2017, Wilson-Cook
Administration (FDA or we) is does not require premarket approval. Medical, Inc. submitted a request for De
classifying the hemostatic device for We determine whether a new device is Novo classification of the Hemospray®
intraluminal gastrointestinal use into substantially equivalent to a predicate Endoscopic Hemostat. FDA reviewed
class II (special controls). The special by means of the procedures for the request in order to classify the
controls that apply to the device type premarket notification under section device under the criteria for
are identified in this order and will be 510(k) of the FD&C Act (21 U.S.C. classification set forth in section
part of the codified language for the 360(k)) and part 807 (21 CFR part 807). 513(a)(1) of the FD&C Act.
hemostatic device for intraluminal FDA may also classify a device
through ‘‘De Novo’’ classification, a We classify devices into class II if
gastrointestinal use’s classification. We general controls by themselves are
are taking this action because we have common name for the process
authorized under section 513(f)(2) of the insufficient to provide reasonable
determined that classifying the device assurance of safety and effectiveness,
into class II (special controls) will FD&C Act. Section 207 of the Food and
Drug Administration Modernization Act but there is sufficient information to
provide a reasonable assurance of safety establish special controls that, in
and effectiveness of the device. We of 1997 (Pub. L. 105–115) established
the first procedure for De Novo combination with the general controls,
believe this action will also enhance provide reasonable assurance of the
patients’ access to beneficial innovative classification. Section 607 of the Food
and Drug Administration Safety and safety and effectiveness of the device for
devices, in part by reducing regulatory its intended use (see 21 U.S.C.
burdens. Innovation Act (Pub. L. 112–144)
modified the De Novo application 360c(a)(1)(B)). After review of the
DATES: This order is effective October information submitted in the request,
process by adding a second procedure.
19, 2018. The classification was we determined that the device can be
A device sponsor may utilize either
applicable on May 7, 2018. classified into class II with the
procedure for De Novo classification.
FOR FURTHER INFORMATION CONTACT: Under the first procedure, the person establishment of special controls. FDA
Maegen Colehour, Center for Devices submits a 510(k) for a device that has has determined that these special
and Radiological Health, Food and Drug not previously been classified. After controls, in addition to the general
Administration, 10903 New Hampshire receiving an order from FDA classifying controls, will provide reasonable
Ave., Bldg. 66, Rm. G423, Silver Spring, the device into class III under section assurance of the safety and effectiveness
MD, 20993–0002, 301–796–6436, 513(f)(1) of the FD&C Act, the person of the device.
Maegen.Colehour@fda.hhs.gov. then requests a classification under Therefore, on May 7, 2018, FDA
SUPPLEMENTARY INFORMATION: section 513(f)(2). issued an order to the requester
Under the second procedure, rather classifying the device into class II. FDA
I. Background is codifying the classification of the
than first submitting a 510(k) and then
Upon request, FDA has classified the a request for classification, if the person device by adding 21 CFR 878.4456. We
hemostatic device for intraluminal determines that there is no legally have named the generic type of device
gastrointestinal use as class II (special marketed device upon which to base a hemostatic device for intraluminal
controls), which we have determined determination of substantial gastrointestinal use, and it is identified
will provide a reasonable assurance of equivalence, that person requests a as a prescription device that is
safety and effectiveness. In addition, we classification under section 513(f)(2) of endoscopically applied to the upper
amozie on DSK3GDR082PROD with RULES
believe this action will enhance the FD&C Act. and/or lower gastrointestinal tract and is
patients’ access to beneficial innovation, Under either procedure for De Novo intended to produce hemostasis via
in part by reducing regulatory burdens classification, FDA is required to absorption of fluid or by other means.
by placing the device into a lower classify the device by written order FDA has identified the following risks
device class than the automatic class III within 120 days. The classification will to health associated specifically with
assignment. be according to the criteria under this type of device and the measures
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![52972 Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations
impurities, physical characteristics, and I. Background Under the second procedure, rather
reactivity with fluids. than first submitting a 510(k) and then
Upon request, FDA has classified the a request for classification, if the person
(ii) Performance testing must
thermal vestibular stimulator for determines that there is no legally
demonstrate the mechanical integrity
headache as class II (special controls), marketed device upon which to base a
and functionality of the system used to
which we have determined will provide determination of substantial
deliver the device and demonstrate the
a reasonable assurance of safety and equivalence, that person requests a
device meets established specifications,
effectiveness. In addition, we believe classification under section 513(f)(2) of
including output pressure for
this action will enhance patients’ access the FD&C Act.
propellant-based systems.
to beneficial innovation, in part by Under either procedure for De Novo
(6) Labeling must include: reducing regulatory burdens by placing
(i) Information identifying and classification, FDA is required to
the device into a lower device class than classify the device by written order
explaining how to use the device and its the automatic class III assignment.
components; and within 120 days. The classification will
The automatic assignment of class III be according to the criteria under
(ii) A shelf life. occurs by operation of law and without section 513(a)(1) of the FD&C Act.
Dated: October 15, 2018. any action by FDA, regardless of the Although the device was automatically
Leslie Kux, level of risk posed by the new device. placed within class III, the De Novo
Associate Commissioner for Policy. Any device that was not in commercial classification is considered to be the
[FR Doc. 2018–22784 Filed 10–18–18; 8:45 am] distribution before May 28, 1976, is initial classification of the device.
BILLING CODE 4164–01–P automatically classified as, and remains We believe this De Novo classification
within, class III and requires premarket will enhance patients’ access to
approval unless and until FDA takes an beneficial innovation, in part by
DEPARTMENT OF HEALTH AND action to classify or reclassify the device reducing regulatory burdens. When FDA
HUMAN SERVICES (see 21 U.S.C. 360c(f)(1)). We refer to classifies a device into class I or II via
these devices as ‘‘postamendments the De Novo process, the device can
Food and Drug Administration devices’’ because they were not in serve as a predicate for future devices of
commercial distribution prior to the that type, including for 510(k)s (see 21
21 CFR Part 882 date of enactment of the Medical Device U.S.C. 360c(f)(2)(B)(i)). As a result, other
Amendments of 1976, which amended device sponsors do not have to submit
[Docket No. FDA–2018–N–3690] the Federal Food, Drug, and Cosmetic a De Novo request or premarket
Act (FD&C Act). application to market a substantially
Medical Devices; Neurological FDA may take a variety of actions in equivalent device (see 21 U.S.C. 360c(i),
Devices; Classification of the Thermal appropriate circumstances to classify or defining ‘‘substantial equivalence’’).
Vestibular Stimulator for Headache reclassify a device into class I or II. We Instead, sponsors can use the less-
may issue an order finding a new device burdensome 510(k) process, when
AGENCY: Food and Drug Administration, necessary, to market their device.
HHS. to be substantially equivalent under
section 513(i) of the FD&C Act (21 II. De Novo Classification
ACTION: Final order. U.S.C. 360c(i)) to a predicate device that
On April 18, 2017, Scion NeuroStim,
does not require premarket approval.
SUMMARY: The Food and Drug LLC submitted a request for De Novo
We determine whether a new device is
Administration (FDA or we) is classification of the
substantially equivalent to a predicate
classifying the thermal vestibular ThermoNeuroModulation Device. FDA
by means of the procedures for
stimulator for headache into class II reviewed the request in order to classify
premarket notification under section
(special controls). The special controls the device under the criteria for
510(k) of the FD&C Act (21 U.S.C.
that apply to the device type are classification set forth in section
360(k)) and part 807 (21 CFR part 807).
identified in this order and will be part 513(a)(1) of the FD&C Act.
of the codified language for the thermal FDA may also classify a device We classify devices into class II if
vestibular stimulator for headache’s through ‘‘De Novo’’ classification, a general controls by themselves are
classification. We are taking this action common name for the process insufficient to provide reasonable
because we have determined that authorized under section 513(f)(2) of the assurance of safety and effectiveness,
classifying the device into class II FD&C Act. Section 207 of the Food and but there is sufficient information to
(special controls) will provide a Drug Administration Modernization Act establish special controls that, in
reasonable assurance of safety and of 1997 (Pub. L. 105–115) established combination with the general controls,
effectiveness of the device. We believe the first procedure for De Novo provide reasonable assurance of the
this action will also enhance patients’ classification. Section 607 of the Food safety and effectiveness of the device for
access to beneficial innovative devices, and Drug Administration Safety and its intended use (see 21 U.S.C.
in part by reducing regulatory burdens. Innovation Act (Pub. L. 112–144) 360c(a)(1)(B)). After review of the
modified the De Novo application information submitted in the request,
DATES: This order is effective October
process by adding a second procedure. we determined that the device can be
19, 2018. The classification was A device sponsor may utilize either
applicable on March 26, 2018. classified into class II with the
procedure for De Novo classification. establishment of special controls. FDA
FOR FURTHER INFORMATION CONTACT: Under the first procedure, the person has determined that these special
Stacie Gutowski, Center for Devices and submits a 510(k) for a device that has controls, in addition to the general
amozie on DSK3GDR082PROD with RULES
Radiological Health, Food and Drug not previously been classified. After controls, will provide reasonable
Administration, 10903 New Hampshire receiving an order from FDA classifying assurance of the safety and effectiveness
Ave., Bldg. 66, Rm. 2656, Silver Spring, the device into class III under section of the device.
MD 20993–0002, 240–402–6032, 513(f)(1) of the FD&C Act, the person Therefore, on March 26, 2018, FDA
Stacie.Gutowski@fda.hhs.gov. then requests a classification under issued an order to the requester
SUPPLEMENTARY INFORMATION: section 513(f)(2). classifying the device into class II. FDA
VerDate Sep<11>2014 16:11 Oct 18, 2018 Jkt 247001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\FR\FM\19OCR1.SGM 19OCR1](https://thefederalregister.org/doc/83_FR_53173/page/3.svg)
Document Created: 2018-10-19 01:25:44
Document Modified: 2018-10-19 01:25:44
| 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 19, 2018. The classification was applicable on May 7, 2018. | |
| Contact | Maegen Colehour, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G423, Silver Spring, MD, 20993-0002, 301- 796-6436, [email protected] | |
| FR Citation | 83 FR 52970 |
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