83 FR 600 - Medical Devices; Radiology Devices; Classification of the Absorbable Perirectal Spacer
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 4 (January 5, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 4 (January 5, 2018)
| Page Range | 600-602 | |
| FR Document | 2018-00051 |
[Federal Register Volume 83, Number 4 (Friday, January 5, 2018)] [Rules and Regulations] [Pages 600-602] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00051] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 892 [Docket No. FDA-2017-N-6539] Medical Devices; Radiology Devices; Classification of the Absorbable Perirectal Spacer AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the absorbable perirectal spacer 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 absorbable perirectal spacer'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 January 5, 2018. The classification was applicable on April 1, 2015. 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 absorbable perirectal spacer 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 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 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 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. [[Page 601]] II. De Novo Classification On October 1, 2014, Augmenix, Inc. submitted a request for De Novo classification of the SpaceOAR System. 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 April 1, 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 892.5725. We have named the generic type of device absorbable perirectal spacer, and it is identified as a device composed of biodegradable material that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose delivered to the anterior rectum. The absorbable spacer maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time. 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--Absorbable Perirectal Spacer Risks and Mitigation Measures ------------------------------------------------------------------------ Mitigation measures/21 CFR Identified risks section ------------------------------------------------------------------------ Device functional failure or the device Special Controls (1)(i) (21 CFR is unable to maintain space stability 892.5725(b)(1)(i)), (1)(ii) during the course of radiation therapy. (21 CFR 892.5725(b)(1)(ii)), (1)(iv) (21 CFR 892.5725(b)(1)(iv)), and (1)(vi) (21 CFR 892.5725(b)(1)(vi)). Prolonged or delayed procedure......... Special Controls (1)(iii) (21 CFR 892.5725(b)(1)(iii)), (1)(iv) (21 CFR 892.5725(b)(1)(iv)), (2) (21 CFR 892.5725(b)(2)), and (3) (21 CFR 892.5725(b)(3)). Needle penetration and/or spacer Special Controls (1)(iv) (21 material injection into bloodstream, CFR 892.5725(b)(1)(iv)), (2) bladder, prostate, rectal wall, (21 CFR 892.5725(b)(2)), and rectum, or urethra. (3) (21 CFR 892.5725(b)(3)). Incomplete absorption.................. Special Controls (1)(iii) (21 CFR 892.5725(b)(1)(iii)), (1)(iv) (21 CFR 892.5725(b)(1)(iv)), and (1)(vii) (21 CFR 892.5725(b)(1)(vii)). Infection or local tissue inflammatory Special Controls (1)(iv) (21 reactions. CFR 892.5725(b)(1)(iv)), (1)(v) (21 CFR 892.5725(b)(1)(v)), (1)(vi) (21 CFR 892.5725(b)(1)(vi)), (1)(vii) (21 CFR 892.5725(b)(1)(vii)), and (3) (21 CFR 892.5725(b)(3)). Pain or discomfort associated with Special Controls (1)(iv) (21 spacer. CFR 892.5725(b)(1)(iv)) and (3) (21 CFR 892.5725(b)(3)). Urine retention, bleeding, rectal Special Controls (1)(iii) (21 mucosal damage, ulcers, necrosis, CFR 892.5725(b)(1)(iii)), constipation, or rectal urgency. (1)(iv) (21 CFR 892.5725(b)(1)(iv)), (1)(vii) (21 CFR 892.5725(b)(1)(vii)), (2) (21 CFR 892.5725(b)(2)), and (3) (21 CFR 892.5725(b)(3)). ------------------------------------------------------------------------ FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act. III. Analysis of Environmental Impact 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; the collections of information in part 820 have been approved under OMB control number 0910-0073; 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 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 892.5725 to subpart F to read as follows: Sec. 892.5725 Absorbable perirectal spacer. (a) Identification. An absorbable perirectal spacer is composed of biodegradable material that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to [[Page 602]] reduce the radiation dose delivered to the anterior rectum. The absorbable spacer maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time. (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. For all clinical investigations used to support premarket notification submissions for this type of device, line listings of the study data must be provided. (i) Performance bench testing must demonstrate appropriate perirectal space creation and maintenance for the duration of prostate radiotherapy. (ii) Performance bench testing must demonstrate that therapeutic radiation levels do not alter the performance of the device. (iii) Performance in vivo testing must demonstrate appropriate deployment of spacer as indicated in the accompanying labeling, and demonstrate appropriate expansion and absorption characteristics in a clinically relevant environment. (iv) Clinical study must demonstrate appropriate spacer stability and lack of migration for the entire course of radiotherapy, complete absorption, and lack of long term toxicity. (v) Sterility testing must demonstrate the sterility of the device and the effects of the sterilization process on the physical characteristics of the spacer. (vi) Shelf-life testing must demonstrate the stability of the physical characteristics of the spacer throughout the shelf-life as indicated in the accompanying labeling. (vii) The device must be demonstrated to be biocompatible. (2) The risk management activities performed as part of the manufacturer's Sec. 820.30 design controls must document an appropriate end user initial training program which will be offered as part of efforts to mitigate the risk of failure to correctly operate the device, including, but not limited to, documentation of an appropriate end user initial training program on the proper spacer deployment technique. (3) The device labeling must include the following: (i) A detailed summary of reported or observed complications related to the use of the device; (ii) Appropriate warnings; (iii) Detailed instructions for system preparations and detailed implant procedure instructions; and (iv) An expiration date that is supported by performance data as specified in paragraph (b)(1)(vi) of this section. Dated: January 2, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00051 Filed 1-4-18; 8:45 am] BILLING CODE 4164-01-P
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Æ Facilities that would qualify as ACTION: Final order. does not require premarket approval.
secondary activities farms except that We determine whether a new device is
they pack, package, label, and/or hold SUMMARY: The Food and Drug substantially equivalent to a predicate
processed food that consists only of Administration (FDA or we) is by means of the procedures for
RACs that have been dried/dehydrated classifying the absorbable perirectal premarket notification under section
to create a distinct commodity (e.g., spacer into class II (special controls). 510(k) of the FD&C Act (21 U.S.C.
dried beans); The special controls that apply to the 360(k)) and part 807 (21 CFR part 807).
Æ Farm mixed-type facilities making device type are identified in this order
and will be part of the codified language FDA may also classify a device
silage food for animals;
• Written assurances under the for the absorbable perirectal spacer’s through ‘‘De Novo’’ classification, a
‘‘customer provisions’’ in part 117 and classification. We are taking this action common name for the process
related rules; because we have determined that authorized under section 513(f)(2) of the
• Importation of food contact classifying the device into class II FD&C Act. Section 207 of the Food and
substances under the FSVP regulation; (special controls) will provide a Drug Administration Modernization Act
and reasonable assurance of safety and of 1997 established the first procedure
• Certain human food by-products for effectiveness of the device. We believe for De Novo classification (Pub. L. 105–
use as animal food, with regard to this action will also enhance patients’ 115). Section 607 of the Food and Drug
certain requirements under part 507. access to beneficial innovative devices, Administration Safety and Innovation
in part by reducing regulatory burdens. Act modified the De Novo application
II. Paperwork Reduction Act of 1995 process by adding a second procedure
DATES: This order is effective January 5,
This guidance refers to previously 2018. The classification was applicable (Pub. L. 112–144). A device sponsor
approved collections of information on April 1, 2015. may utilize either procedure for De
found in FDA regulations. These Novo classification.
collections of information are subject to FOR FURTHER INFORMATION CONTACT:
Steven Tjoe, Center for Devices and Under the first procedure, the person
review by the Office of Management and submits a 510(k) for a device that has
Budget (OMB) under the Paperwork Radiological Health, Food and Drug
Administration, 10903 New Hampshire not previously been classified. After
Reduction Act of 1995 (44 U.S.C. 3501– receiving an order from FDA classifying
3520). The collections of information in Ave., Bldg. 66, Rm. 4550, Silver Spring,
MD 20993–0002, 301–796–5866, the device into class III under section
part 117 have been approved under 513(f)(1) of the FD&C Act, the person
OMB control number 0910–0751. The steven.tjoe@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
then requests a classification under
collections of information in part 507 section 513(f)(2).
have been approved under OMB control I. Background
number 0910–0789. The collections of Under the second procedure, rather
information in 21 CFR part 1, subpart L Upon request, FDA has classified the than first submitting a 510(k) and then
have been approved under OMB control absorbable perirectal spacer as class II a request for classification, if the person
number 0910–0752. The collections of (special controls), which we have determines that there is no legally
information in part 112 have been determined will provide a reasonable marketed device upon which to base a
approved under OMB control number assurance of safety and effectiveness. In determination of substantial
0910–0816. addition, we believe this action will equivalence, that person requests a
enhance patients’ access to beneficial classification under section 513(f)(2) of
II. Electronic Access innovation, in part by reducing the FD&C Act.
Persons with access to the internet regulatory burdens by placing the Under either procedure for De Novo
may obtain the guidance at either device into a lower device class than the classification, FDA shall classify the
https://www.fda.gov/FoodGuidances or automatic class III assignment. device by written order within 120 days.
https://www.regulations.gov. Use the The automatic assignment of class III
The classification will be according to
FDA website listed in the previous occurs by operation of law and without
the criteria under section 513(a)(1) of
sentence to find the most current any action by FDA, regardless of the
the FD&C Act. Although the device was
version of the guidance. level of risk posed by the new device.
automatically placed within class III,
Dated: January 2, 2018. Any device that was not in commercial
the De Novo classification is considered
distribution before May 28, 1976, is
Leslie Kux, to be the initial classification of the
automatically classified as, and remains
Associate Commissioner for Policy. device.
within, class III and requires premarket
[FR Doc. 2018–00050 Filed 1–4–18; 8:45 am] We believe this De Novo classification
approval unless and until FDA takes an
BILLING CODE 4164–01–P
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
these devices as ‘‘postamendments reducing regulatory burdens. When FDA
DEPARTMENT OF HEALTH AND classifies a device into class I or II via
devices’’ because they were not in
HUMAN SERVICES the De Novo process, the device can
commercial distribution prior to the
Food and Drug Administration date of enactment of the Medical Device serve as a predicate for future devices of
Amendments of 1976, which amended that type, including for 510(k)s (see 21
21 CFR Part 892 the Federal Food, Drug, and Cosmetic U.S.C. 360c(f)(2)(B)(i)). As a result, other
Act (FD&C Act). device sponsors do not have to submit
[Docket No. FDA–2017–N–6539] FDA may take a variety of actions in a De Novo request or premarket
daltland on DSKBBV9HB2PROD with RULES
appropriate circumstances to classify or approval application in order to market
Medical Devices; Radiology Devices;
reclassify a device into class I or II. We a substantially equivalent device (see 21
Classification of the Absorbable
may issue an order finding a new device U.S.C. 360c(i), defining ‘‘substantial
Perirectal Spacer
to be substantially equivalent under equivalence’’). Instead, sponsors can use
AGENCY: Food and Drug Administration, section 513(i) of the FD&C Act (21 the less-burdensome 510(k) process,
HHS. U.S.C. 360c(i)) to a predicate device that when necessary, to market their device.
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![602 Federal Register / Vol. 83, No. 4 / Friday, January 5, 2018 / Rules and Regulations
reduce the radiation dose delivered to (iv) An expiration date that is selecting ‘‘Search’’. Select the link
the anterior rectum. The absorbable supported by performance data as ‘‘Submit a Comment’’ that corresponds
spacer maintains space for the entire specified in paragraph (b)(1)(vi) of this with ‘‘FTR Case 2017–301’’ and follow
course of prostate radiotherapy section. the instructions provided on the screen.
treatment and is completely absorbed by Dated: January 2, 2018. Please include your name, company
the patient’s body over time. Leslie Kux,
name (if any), and ‘‘FTR Case 2017–
(b) Classification. Class II (special 301’’ on your attached document.
Associate Commissioner for Policy.
controls). The special controls for this • Mail: General Services
[FR Doc. 2018–00051 Filed 1–4–18; 8:45 am] Administration, Regulatory Secretariat
device are:
BILLING CODE 4164–01–P Division (MVCB), Attn: Lois Mandell,
(1) The premarket notification
submission must include methodology 1800 F Street NW, Washington, DC
and results of the following non-clinical 20405.
and clinical performance testing. For all GENERAL SERVICES Instructions: Please submit comments
clinical investigations used to support ADMINISTRATION only and cite ‘‘FTR Case 2017–301’’ in
premarket notification submissions for all correspondence related to this case.
this type of device, line listings of the 41 CFR Parts 300–3, 300–70, 301–10, All comments received will be posted
study data must be provided. 301–70, Appendix C to Chapter 301, without change to http://
(i) Performance bench testing must Parts 302–1, 302–4, and 304–2 www.regulations.gov, including any
demonstrate appropriate perirectal [FTR Amendment 2017–01; FTR Case 2017– personal and/or business confidential
space creation and maintenance for the 301; Docket No. 2017–0004, Sequence 1] information provided. To confirm
duration of prostate radiotherapy. receipt of your comment(s), please
RIN 3090–AJ89 check www.regulations.gov
(ii) Performance bench testing must
demonstrate that therapeutic radiation Federal Travel Regulation; approximately two to three days after
levels do not alter the performance of Transportation Network Companies submission to verify posting (except
the device. (TNC), Innovative Mobility Technology allow 30 days for posting of comments
(iii) Performance in vivo testing must Companies, and Reporting Travel, submitted by mail).
demonstrate appropriate deployment of Transportation, and Relocation Costs FOR FURTHER INFORMATION CONTACT: For
spacer as indicated in the accompanying clarification of content, contact Mr. Cy
labeling, and demonstrate appropriate AGENCY: Office of Government-wide Greenidge, Program Analyst, Office of
expansion and absorption Policy (OGP), General Services Government-wide Policy, at 202–219–
characteristics in a clinically relevant Administration (GSA). 2349 or cy.greenidge@gsa.gov. For more
environment. ACTION: Direct final rule; request for information pertaining to status or
(iv) Clinical study must demonstrate comments. publication schedules, contact the
appropriate spacer stability and lack of Regulatory Secretariat (MVCB), 1800 F
migration for the entire course of SUMMARY: GSA is amending the Federal Street NW, Washington, DC 20405, 202–
radiotherapy, complete absorption, and Travel Regulation (FTR) by adding 501–4755. Please cite FTR Case 2017–
lack of long term toxicity. terms and definitions for ‘‘innovative 301.
(v) Sterility testing must demonstrate mobility technology company’’, ‘‘taxi’’,
SUPPLEMENTARY INFORMATION:
the sterility of the device and the effects and ‘‘transportation network company
of the sterilization process on the (TNC)’’, and designating ‘‘innovative A. Public Participation
physical characteristics of the spacer. mobility technology company’’ and GSA is publishing this direct final
(vi) Shelf-life testing must ‘‘TNC’’ as forms of special conveyances. rule without a prior proposed rule
demonstrate the stability of the physical In addition, this direct final rule adds a because this is a noncontroversial action
characteristics of the spacer throughout due date by which agencies must report required by statute, and GSA anticipates
the shelf-life as indicated in the travel, transportation, and relocation no significant adverse comments.
accompanying labeling. costs and data to GSA. These actions are A significant adverse comment is
(vii) The device must be demonstrated required by the Modernizing defined as one where the comment
to be biocompatible. Government Travel Act. explains why the rule would be
(2) The risk management activities DATES: This rule is effective on February inappropriate, including challenges to
performed as part of the manufacturer’s 20, 2018 without further notice, unless the rule’s underlying premise or
§ 820.30 design controls must document GSA receives adverse comments by approach, or would be ineffective or
an appropriate end user initial training February 5, 2018. unacceptable without a change. In
program which will be offered as part of GSA will consider whether these determining whether a significant
efforts to mitigate the risk of failure to comments are significant enough to adverse comment is sufficient to
correctly operate the device, including, publish a timely withdrawal in the terminate a direct final rulemaking, GSA
but not limited to, documentation of an Federal Register informing the public will consider whether the comment
appropriate end user initial training that this direct final rule will not take raises an issue serious enough to
program on the proper spacer effect. Please see SUPPLEMENTARY warrant a substantive response in a
deployment technique. INFORMATION for more information on notice-and-comment process. GSA notes
(3) The device labeling must include significant adverse comments. that comments that are frivolous,
the following: ADDRESSES: Submit comments insubstantial, or outside the scope of the
(i) A detailed summary of reported or identified by FTR Case 2017–301 by any rule would not be considered adverse
daltland on DSKBBV9HB2PROD with RULES
observed complications related to the of the following methods: under this procedure. A comment
use of the device; • Regulations.gov: http:// recommending a rule change in addition
(ii) Appropriate warnings; www.regulations.gov. Submit comments to the rule would not be considered a
(iii) Detailed instructions for system via the Federal eRulemaking portal by significant adverse comment, unless the
preparations and detailed implant entering ‘‘FTR Case 2017–301’’ under comment states why the rule would be
procedure instructions; and the heading ‘‘Enter Keyword or ID’’ and ineffective without the additional
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Document Created: 2018-10-26 09:31:23
Document Modified: 2018-10-26 09:31:23
| 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 January 5, 2018. The classification was applicable on April 1, 2015. | |
| 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 | 83 FR 600 | |
| CFR Associated | Medical Devices; Radiation Protection and X-Rays |
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