82 FR 61170 - Medical Devices; Radiology Devices; Classification of the Rectal Balloon for Prostate Immobilization
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 247 (December 27, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 247 (December 27, 2017)
| Page Range | 61170-61171 | |
| FR Document | 2017-27856 |
[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)] [Rules and Regulations] [Pages 61170-61171] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27856] [[Page 61170]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 892 [Docket No. FDA-2017-N-6855] Medical Devices; Radiology Devices; Classification of the Rectal Balloon for Prostate Immobilization AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the rectal balloon for prostate immobilization 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 rectal balloon for prostate immobilization'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 December 27, 2017. The classification was applicable on January 28, 2014. FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the rectal balloon for prostate immobilization 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 (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807). FDA may also classify a device through ``De Novo'' classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification. Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After 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. As a result, other device sponsors do not have to submit a De Novo request or PMA 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 July 15, 2013, RadiaDyne, LLC submitted a request for De Novo classification of the prostate immobilizer rectal balloon. 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 January 28, 2014, 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 892.5720. We have named the generic type of device rectal balloon for prostate immobilization, and it is identified as a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery. 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 61171]] Table 1--Rectal Balloon for Prostate Immobilization Risks and Mitigation Measures ------------------------------------------------------------------------ Mitigation measures/ Identified risks 21 CFR section ------------------------------------------------------------------------ Anorectal Toxicity............................... Special controls (1)(i) (21 CFR 892.5720(b)(1)(i)), (1)(ii) (21 CFR 892.5720(b)(1)(ii)), (1)(iii) (21 CFR 892.5720(b)(1)(iii)) , (1)(iv) (21 CFR 892.5720(b)(1)(iv)), (2)(i)(D) (21 CFR 892.5720(b)(2)(i)(D) ), (2)(ii) (21 CFR 892.5720(b)(2)(ii)), (2)(iii) (21 CFR 892.5720(b)(2)(iii)) , and (2)(iv) (21 CFR 892.5720(b)(2)(iv)). Tissue Damage.................................... Special controls (1)(iv) (21 CFR 892.5720(b)(1)(iv)), (1)(v) (21 CFR 892.5720(b)(1)(v)), (2)(i)(A) (21 CFR 892.5720(b)(2)(i)(A) ), (2)(i)(D) (21 CFR 892.5720(b)(2)(i)(D) ), (2)(ii) (21 CFR 892.5720(b)(2)(ii)), (2)(iii) (21 CFR 892.5720(b)(2)(iii)) , and (2)(iv) (21 CFR 892.5720(b)(2)(iv)). Perforation of the Rectum........................ Special controls (1)(v)(A) (21 CFR 892.5720(b)(1)(v)(A) ), (1)(v)(B) (21 CFR 892.5720(b)(1)(v)(B) ), (2)(i)(A) (21 CFR 892.5720(b)(2)(i)(A) ), (2)(i)(D) (21 CFR 892.5720(b)(2)(i)(D) ), (2)(ii) (21 CFR 892.5720(b)(2)(ii)), (2)(iii) (21 CFR 892.5720(b)(2)(iii)) , and (2)(iv) (21 CFR 892.5720(b)(2)(iv)). Irradiation of Healthy Tissue.................... Special controls (1)(v)(A) (21 CFR 892.5720(b)(1)(v)(A) ), (1)(v)(B) (21 CFR 892.5720(b)(1)(v)(B) ), (2)(i)(B) (21 CFR 892.5720(b)(2)(i)(B) ), (2)(ii) (21 CFR 892.5720(b)(2)(ii)), (2)(iii) (21 CFR 892.5720(b)(2)(iii)) , and (2)(iv) (21 CFR 892.5720(b)(2)(iv)). Patient Intolerance.............................. Special controls (1)(v)(A) (21 CFR 892.5720(b)(1)(v)(A) ), (2)(i)(A) (21 CFR 892.5720(b)(2)(i)(A) ), (2)(i)(C) (21 CFR 892.5720(b)(2)(i)(C) ), (2)(ii) (21 CFR 892.5720(b)(2)(ii)), (2)(iii) (21 CFR 892.5720(b)(2)(iii)) , and (2)(iv) (21 CFR 892.5720(b)(2)(iv)). ------------------------------------------------------------------------ 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. This device is subject to premarket notification requirements under section 510(k). III. Analysis of Environmental Impact The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. IV. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 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 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 892 Medical devices, Radiation protection, X-rays. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 892 is amended as follows: PART 892--RADIOLOGY DEVICES 0 1. The authority citation for part 892 is revised to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 892.5720 to subpart F to read as follows: Sec. 892.5720 Rectal balloon for prostate immobilization. (a) Identification. A rectal balloon for prostate immobilization is a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery. (b) Classification. Class II (special controls). The special controls for this device are: (1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing: (i) Biocompatibility testing of the final finished device; (ii) If provided sterile, sterilization validation; (iii) If not provided sterile, bioburden testing of the final finished device; (iv) Shelf life and expiration date validation; and (v) Performance testing including but not limited to: (A) Venting mechanism (if device has a vent mechanism); (B) Safety mechanism(s) to prevent advancement beyond its intended safe placement; and (C) Structural integrity testing (e.g., tensile strength, balloon leakage and burst strength). (2) Labeling that includes: (i) Appropriate warnings and contraindications, including, but not limited to the following statements: (A) ``Do not transport the patient with the rectal balloon inserted. The balloon should be removed prior to transport.''; (B) ``Failure to perform the standard imaging position verification protocol may cause the device to not perform as intended.''; (C) ``Reduce the rectal balloon fill volume if the patient experiences discomfort due to the rectal balloon inflation.''; and (D) ``Do not apply excessive pressure/force on the shaft or tubing of the rectal balloon.'' (ii) Adequate instructions for use on the proper insertion procedure, positioning, and inflation of the rectal balloon; (iii) Whether the device is sterile or non-sterile; and (iv) An expiration date. Dated: December 20, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27856 Filed 12-26-17; 8:45 am] BILLING CODE 4164-01-P
![61170 Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations
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 892 commercial distribution prior to the the De Novo process, the device can
[Docket No. FDA–2017–N–6855] 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. As a
Medical Devices; Radiology Devices; the Federal Food, Drug, and Cosmetic result, other device sponsors do not
Classification of the Rectal Balloon for Act (FD&C Act). have to submit a De Novo request or
Prostate Immobilization FDA may take a variety of actions in PMA in order to market a substantially
appropriate circumstances to classify or equivalent device (see 21 U.S.C. 360c(i),
AGENCY: Food and Drug Administration, defining ‘‘substantial equivalence’’).
reclassify a device into class I or II. We
HHS. Instead, sponsors can use the less-
may issue an order finding a new device
ACTION: Final order. to be substantially equivalent under burdensome 510(k) process, when
SUMMARY: The Food and Drug section 513(i) of the FD&C Act (see 21 necessary, to market their device.
Administration (FDA or we) is U.S.C. 360c(i)) to a predicate device that II. De Novo Classification
classifying the rectal balloon for prostate does not require premarket approval.
immobilization into class II (special We determine whether a new device is On July 15, 2013, RadiaDyne, LLC
controls). The special controls that substantially equivalent to a predicate submitted a request for De Novo
apply to the device type are identified by means of the procedures for classification of the prostate
in this order and will be part of the premarket notification under section immobilizer rectal balloon. FDA
codified language for the rectal balloon 510(k) of the FD&C Act (21 U.S.C. reviewed the request in order to classify
for prostate immobilization’s 360(k)) and part 807 (21 CFR part 807). the device under the criteria for
classification. We are taking this action FDA may also classify a device classification set forth in section
because we have determined that through ‘‘De Novo’’ classification, a 513(a)(1) of the FD&C Act.
classifying the device into class II common name for the process We classify devices into class II if
(special controls) will provide a authorized under section 513(f)(2) of the general controls by themselves are
reasonable assurance of safety and FD&C Act. Section 207 of the Food and insufficient to provide reasonable
effectiveness of the device. We believe Drug Administration Modernization Act assurance of safety and effectiveness,
this action will also enhance patients’ of 1997 established the first procedure but there is sufficient information to
access to beneficial innovative devices, for De Novo classification (Pub. L. 105– establish special controls that, in
in part by reducing regulatory burdens. 115). Section 607 of the Food and Drug combination with the general controls,
DATES: This order is effective December Administration Safety and Innovation provide reasonable assurance of the
27, 2017. The classification was Act modified the De Novo application safety and effectiveness of the device for
applicable on January 28, 2014. process by adding a second procedure its intended use (see 21 U.S.C.
FOR FURTHER INFORMATION CONTACT:
(Pub. L. 112–144). A device sponsor 360c(a)(1)(B)). After review of the
Steven Tjoe, Center for Devices and may utilize either procedure for De information submitted in the request,
Radiological Health, Food and Drug Novo classification. we determined that the device can be
Administration, 10903 New Hampshire Under the first procedure, the person classified into class II with the
Ave., Bldg. 66, Rm. 4550, Silver Spring, submits a 510(k) for a device that has establishment of special controls. FDA
MD 20993–0002, 301–796–5866, not previously been classified. After has determined that these special
steven.tjoe@fda.hhs.gov. receiving an order from FDA classifying controls, in addition to general controls,
the device into class III under section will provide reasonable assurance of the
SUPPLEMENTARY INFORMATION:
513(f)(1) of the FD&C Act, the person safety and effectiveness of the device.
I. Background then requests a classification under Therefore, on January 28, 2014, FDA
Upon request, FDA has classified the section 513(f)(2). issued an order to the requestor
rectal balloon for prostate Under the second procedure, rather classifying the device into class II. FDA
immobilization as class II (special than first submitting a 510(k) and then is codifying the classification of the
controls), which we have determined a request for classification, if the person device by adding 21 CFR 892.5720. We
will provide a reasonable assurance of determines that there is no legally have named the generic type of device
safety and effectiveness. In addition, we marketed device upon which to base a rectal balloon for prostate
believe this action will enhance determination of substantial immobilization, and it is identified as a
patients’ access to beneficial innovation, equivalence, that person requests a single use, inflatable, non-powered
in part by reducing regulatory burdens classification under section 513(f)(2) of positioning device placed in the rectum
by placing the device into a lower the FD&C Act. to immobilize the prostate in patients
device class than the automatic class III Under either procedure for De Novo undergoing radiation therapy. The
assignment. classification, FDA is required to device is intended to be used during all
The automatic assignment of class III classify the device by written order the phases of radiation therapy,
occurs by operation of law and without within 120 days. The classification will including treatment planning, image
any action by FDA, regardless of the be according to the criteria under verification, and radiotherapy delivery.
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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.
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![Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Rules and Regulations 61171
TABLE 1—RECTAL BALLOON FOR PROSTATE IMMOBILIZATION RISKS AND MITIGATION MEASURES
Identified risks Mitigation measures/21 CFR section
Anorectal Toxicity ................................... Special controls (1)(i) (21 CFR 892.5720(b)(1)(i)), (1)(ii) (21 CFR 892.5720(b)(1)(ii)), (1)(iii) (21 CFR
892.5720(b)(1)(iii)), (1)(iv) (21 CFR 892.5720(b)(1)(iv)), (2)(i)(D) (21 CFR 892.5720(b)(2)(i)(D)),
(2)(ii) (21 CFR 892.5720(b)(2)(ii)), (2)(iii) (21 CFR 892.5720(b)(2)(iii)), and (2)(iv) (21 CFR
892.5720(b)(2)(iv)).
Tissue Damage ...................................... Special controls (1)(iv) (21 CFR 892.5720(b)(1)(iv)), (1)(v) (21 CFR 892.5720(b)(1)(v)), (2)(i)(A) (21
CFR 892.5720(b)(2)(i)(A)), (2)(i)(D) (21 CFR 892.5720(b)(2)(i)(D)), (2)(ii) (21 CFR
892.5720(b)(2)(ii)), (2)(iii) (21 CFR 892.5720(b)(2)(iii)), and (2)(iv) (21 CFR 892.5720(b)(2)(iv)).
Perforation of the Rectum ...................... Special controls (1)(v)(A) (21 CFR 892.5720(b)(1)(v)(A)), (1)(v)(B) (21 CFR 892.5720(b)(1)(v)(B)),
(2)(i)(A) (21 CFR 892.5720(b)(2)(i)(A)), (2)(i)(D) (21 CFR 892.5720(b)(2)(i)(D)), (2)(ii) (21 CFR
892.5720(b)(2)(ii)), (2)(iii) (21 CFR 892.5720(b)(2)(iii)), and (2)(iv) (21 CFR 892.5720(b)(2)(iv)).
Irradiation of Healthy Tissue .................. Special controls (1)(v)(A) (21 CFR 892.5720(b)(1)(v)(A)), (1)(v)(B) (21 CFR 892.5720(b)(1)(v)(B)),
(2)(i)(B) (21 CFR 892.5720(b)(2)(i)(B)), (2)(ii) (21 CFR 892.5720(b)(2)(ii)), (2)(iii) (21 CFR
892.5720(b)(2)(iii)), and (2)(iv) (21 CFR 892.5720(b)(2)(iv)).
Patient Intolerance ................................. Special controls (1)(v)(A) (21 CFR 892.5720(b)(1)(v)(A)), (2)(i)(A) (21 CFR 892.5720(b)(2)(i)(A)),
(2)(i)(C) (21 CFR 892.5720(b)(2)(i)(C)), (2)(ii) (21 CFR 892.5720(b)(2)(ii)), (2)(iii) (21 CFR
892.5720(b)(2)(iii)), and (2)(iv) (21 CFR 892.5720(b)(2)(iv)).
FDA has determined that special OMB control number 0910–0120; and (iii) If not provided sterile, bioburden
controls, in combination with the the collections of information in 21 CFR testing of the final finished device;
general controls, address these risks to part 801, regarding labeling, have been (iv) Shelf life and expiration date
health and provide reasonable assurance approved under OMB control number validation; and
of safety and effectiveness. For a device 0910–0485. (v) Performance testing including but
to fall within this classification, and not limited to:
List of Subjects in 21 CFR Part 892
thus avoid automatic classification in
class III, it would have to comply with Medical devices, Radiation (A) Venting mechanism (if device has
the special controls named in this final protection, X-rays. a vent mechanism);
order. The necessary special controls Therefore, under the Federal Food, (B) Safety mechanism(s) to prevent
appear in the regulation codified by this Drug, and Cosmetic Act and under advancement beyond its intended safe
order. This device is subject to authority delegated to the Commissioner placement; and
premarket notification requirements of Food and Drugs, 21 CFR part 892 is (C) Structural integrity testing (e.g.,
under section 510(k). amended as follows: tensile strength, balloon leakage and
III. Analysis of Environmental Impact burst strength).
PART 892—RADIOLOGY DEVICES (2) Labeling that includes:
The Agency has determined under 21
CFR 25.34(b) that this action is of a type ■ 1. The authority citation for part 892 (i) Appropriate warnings and
that does not individually or is revised to read as follows: contraindications, including, but not
cumulatively have a significant effect on limited to the following statements:
Authority: 21 U.S.C. 351, 360, 360c, 360e,
the human environment. Therefore, 360j, 360l, 371.
(A) ‘‘Do not transport the patient with
neither an environmental assessment the rectal balloon inserted. The balloon
nor an environmental impact statement ■ 2. Add § 892.5720 to subpart F to read should be removed prior to transport.’’;
is required. as follows: (B) ‘‘Failure to perform the standard
IV. Paperwork Reduction Act of 1995 § 892.5720 Rectal balloon for prostate imaging position verification protocol
immobilization. may cause the device to not perform as
This final order establishes special intended.’’;
controls that refer to previously (a) Identification. A rectal balloon for
prostate immobilization is a single use, (C) ‘‘Reduce the rectal balloon fill
approved collections of information
inflatable, non-powered positioning volume if the patient experiences
found in other FDA regulations. These
device placed in the rectum to discomfort due to the rectal balloon
collections of information are subject to
immobilize the prostate in patients inflation.’’; and
review by the Office of Management and
Budget (OMB) under the Paperwork undergoing radiation therapy. The (D) ‘‘Do not apply excessive pressure/
Reduction Act of 1995 (44 U.S.C. 3501– device is intended to be used during all force on the shaft or tubing of the rectal
3520). The collections of information in the phases of radiation therapy, balloon.’’
the guidance document ‘‘De Novo including treatment planning, image (ii) Adequate instructions for use on
Classification Process (Evaluation of verification, and radiotherapy delivery. the proper insertion procedure,
Automatic Class III Designation)’’ have (b) Classification. Class II (special positioning, and inflation of the rectal
been approved under OMB control controls). The special controls for this balloon;
number 0910–0844; the collections of device are: (iii) Whether the device is sterile or
information in 21 CFR part 814, (1) The premarket notification non-sterile; and
subparts A through E, regarding submission must include methodology
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(iv) An expiration date.
premarket approval, have been and results of the following non-clinical
approved under OMB control number and clinical performance testing: Dated: December 20, 2017.
0910–0231; the collections of (i) Biocompatibility testing of the final Leslie Kux,
information in part 807, subpart E, finished device; Associate Commissioner for Policy.
regarding premarket notification (ii) If provided sterile, sterilization [FR Doc. 2017–27856 Filed 12–26–17; 8:45 am]
submissions, have been approved under validation; BILLING CODE 4164–01–P
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Document Created: 2017-12-27 02:23:21
Document Modified: 2017-12-27 02:23:21
| 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 December 27, 2017. The classification was applicable on January 28, 2014. | |
| Contact | Steven Tjoe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866, [email protected] | |
| FR Citation | 82 FR 61170 | |
| CFR Associated | Medical Devices; Radiation Protection and X-Rays |
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