83_FR_4161 83 FR 4141 - Medical Devices; General and Plastic Surgery Devices; Classification of the Surgical Smoke Precipitator

83 FR 4141 - Medical Devices; General and Plastic Surgery Devices; Classification of the Surgical Smoke Precipitator

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 20 (January 30, 2018)

Page Range4141-4143
FR Document2018-01639

The Food and Drug Administration (FDA or we) is classifying the surgical smoke precipitator 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 surgical smoke precipitator'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.

Federal Register, Volume 83 Issue 20 (Tuesday, January 30, 2018) 
[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Rules and Regulations]
[Pages 4141-4143]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01639]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2017-N-6598]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Surgical Smoke Precipitator

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the surgical smoke precipitator 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 surgical smoke 
precipitator'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 30, 2018. The classification was 
applicable on December 20, 2016.

FOR FURTHER INFORMATION CONTACT: Steven Elliott, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2565, Silver Spring, MD 20993-0002, 301-796-5285, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the surgical smoke precipitator 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 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

[[Page 4142]]

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.

II. De Novo Classification

    On May 26, 2015, Alesi Surgical submitted a request for De Novo 
classification of the UltravisionTM Visual Field Clearing 
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 the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on December 20, 2016, 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 878.5050. We have named 
the generic type of device surgical smoke precipitator, and it is 
identified as a prescription device intended for clearance of the 
visual field by precipitation of surgical smoke and other aerosolized 
particulate matter created during laparoscopic surgery.
    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--Surgical Smoke Precipitator Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Electrical shock.......................  Electrical safety testing and
                                          Labeling.
Electromagnetic interference with other  Electromagnetic compatibility
 devices.                                 testing and Labeling.
Infection..............................  Sterilization validation, Shelf-
                                          life validation, and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Tissue injury..........................  Animal testing; Software
                                          verification, validation, and
                                          hazard analysis; 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. This device is subject to premarket notification 
requirements under section 510(k) of the FD&C Act.
    At the time of classification, surgical smoke precipitators 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

    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 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.


[[Page 4143]]


    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.  878.5050 to subpart F to read as follows:


Sec.  878.5050  Surgical smoke precipitator.

    (a) Identification. A surgical smoke precipitator is a prescription 
device intended for clearance of the visual field by precipitation of 
surgical smoke and other aerosolized particulate matter created during 
laparoscopic surgery.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Adverse tissue reaction must be mitigated through the 
following:
    (i) Chemical characterization and toxicological risk assessment of 
the treated surgical smoke.
    (ii) Demonstration that the elements of the device that may contact 
the patient are biocompatible.
    (2) Electrical safety and electromagnetic compatibility testing 
must demonstrate that the device performs as intended.
    (3) Software verification, validation, and hazard analysis must be 
performed.
    (4) Performance data must demonstrate the sterility of the patient 
contacting components of the device.
    (5) Performance data must support the shelf life of the sterile 
components of the device by demonstrating continued functionality, 
sterility, and package integrity over the identified shelf life.
    (6) Animal simulated-use testing must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Device must be demonstrated to be effectively inserted, 
positioned, and removed from the site of use.
    (ii) Device must be demonstrated to precipitate surgical smoke 
particulates to clear the visual field for laparoscopic surgeries.
    (iii) Device must be demonstrated to be non-damaging to the site of 
use and animal subject.
    (7) Labeling must identify the following:
    (i) Detailed instructions for use.
    (ii) Electrical safety and electromagnetic compatibility 
information.
    (iii) A shelf life.

    Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01639 Filed 1-29-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Rules and Regulations 4141 § 870.1251 Temporary catheter for embolic (4) Performance data must and effectiveness of the device. We protection during transcatheter intracardiac demonstrate the sterility of the device believe this action will also enhance procedures. components intended to be provided patients’ access to beneficial innovative (a) Identification. This device is a sterile. devices, in part by reducing regulatory single use percutaneous catheter system (5) Performance data must support the burdens. that has (a) blood filter(s) at the distal shelf life of the device by demonstrating DATES: This order is effective January end. This device is indicated for use continued sterility, package integrity, 30, 2018. The classification was while performing transcatheter and device functionality over the applicable on December 20, 2016. intracardiac procedures. The device is identified shelf life. FOR FURTHER INFORMATION CONTACT: used to filter blood in a manner that (6) Labeling for the device must may prevent embolic material Steven Elliott, Center for Devices and include: Radiological Health, Food and Drug (thrombus/debris) from the transcatheter (i) Instructions for use; intracardiac procedure from traveling Administration, 10903 New Hampshire (ii) Compatible transcatheter Ave., Bldg. 66, Rm. 2565, Silver Spring, towards the cerebral circulation. intracardiac procedure devices; (b) Classification. Class II (special MD 20993–0002, 301–796–5285, (iii) A detailed summary of the steven.elliott@fda.hhs.gov. controls). The special controls for this clinical testing conducted; and device are: SUPPLEMENTARY INFORMATION: (iv) A shelf life and storage (1) Non-clinical performance testing I. Background conditions. must demonstrate that the device (7) Clinical performance testing must Upon request, FDA has classified the performs as intended under anticipated demonstrate: surgical smoke precipitator as class II conditions of use. The following (i) The ability to safely deliver, (special controls), which we have performance characteristics must be deploy, and remove the device; determined will provide a reasonable tested: (i) Simulated-use testing in a (ii) The ability of the device to filter assurance of safety and effectiveness. In clinically relevant bench anatomic embolic material while not impeding addition, we believe this action will model to assess the following: blood flow; enhance patients’ access to beneficial (A) Delivery, deployment, and (iii) Secure positioning and stability innovation, in part by reducing retrieval, including quantifying of the position throughout the regulatory burdens by placing the deployment and retrieval forces, and transcatheter intracardiac procedure; device into a lower device class than the procedural time; and and automatic class III assignment. (B) Device compatibility and lack of (iv) Evaluation of all adverse events The automatic assignment of class III interference with the transcatheter including death, stroke, and vascular occurs by operation of law and without intracardiac procedure and device. injury. any action by FDA, regardless of the (ii) Tensile strengths of joints and Dated: January 24, 2018. level of risk posed by the new device. components, tip flexibility, torque Leslie Kux, Any device that was not in commercial strength, torque response, and kink Associate Commissioner for Policy. distribution before May 28, 1976, is resistance. [FR Doc. 2018–01638 Filed 1–29–18; 8:45 am] automatically classified as, and remains (iii) Flow characteristics. within, class III and requires premarket (A) The ability of the filter to not BILLING CODE 4164–01–P approval unless and until FDA takes an impede blood flow. action to classify or reclassify the device (B) The amount of time the filter can (see 21 U.S.C. 360c(f)(1)). We refer to be deployed in position and/or retrieved DEPARTMENT OF HEALTH AND HUMAN SERVICES these devices as ‘‘postamendments from its location without disrupting devices’’ because they were not in blood flow. Food and Drug Administration commercial distribution prior to the (iv) Characterization and verification date of enactment of the Medical Device of all dimensions. Amendments of 1976, which amended (2) Animal testing must demonstrate 21 CFR Part 878 the Federal Food, Drug, and Cosmetic that the device performs as intended [Docket No. FDA–2017–N–6598] Act (FD&C Act). under anticipated conditions of use. The Medical Devices; General and Plastic FDA may take a variety of actions in following performance characteristics Surgery Devices; Classification of the appropriate circumstances to classify or must be assessed: (i) Delivery, deployment, and Surgical Smoke Precipitator reclassify a device into class I or II. We retrieval, including quantifying may issue an order finding a new device procedural time. AGENCY: Food and Drug Administration, to be substantially equivalent under (ii) Device compatibility and lack of HHS. section 513(i) of the FD&C Act (21 interference with the transcatheter ACTION: Final order. U.S.C. 360c(i)) to a predicate device that intracardiac procedure and device. does not require premarket approval. (iii) Flow characteristics. SUMMARY: The Food and Drug We determine whether a new device is (A) The ability of the filter to not Administration (FDA or we) is substantially equivalent to a predicate impede blood flow. classifying the surgical smoke by means of the procedures for (B) The amount of time the filter can precipitator into class II (special premarket notification under section be deployed in position and/or retrieved controls). The special controls that 510(k) of the FD&C Act and part 807 (21 from its location without disrupting apply to the device type are identified U.S.C. 360(k) and 21 CFR part 807, rmajette on DSKBCKNHB2PROD with RULES blood flow. in this order and will be part of the respectively). (iv) Gross pathology and codified language for the surgical smoke FDA may also classify a device histopathology assessing vascular injury precipitator’s classification. We are through ‘‘De Novo’’ classification, a and downstream embolization. taking this action because we have common name for the process (3) All patient contacting components determined that classifying the device authorized under section 513(f)(2) of the of the device must be demonstrated to into class II (special controls) will FD&C Act. Section 207 of the Food and be biocompatible. provide a reasonable assurance of safety Drug Administration Modernization Act VerDate Sep<11>2014 15:14 Jan 29, 2018 Jkt 244001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\30JAR1.SGM 30JAR1

4142 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Rules and Regulations of 1997 established the first procedure the De Novo classification is considered but there is sufficient information to for De Novo classification (Pub. L. 105– to be the initial classification of the establish special controls that, in 115). Section 607 of the Food and Drug device. combination with the general controls, Administration Safety and Innovation We believe this De Novo classification provide reasonable assurance of the Act modified the De Novo application will enhance patients’ access to safety and effectiveness of the device for process by adding a second procedure beneficial innovation, in part by its intended use (see 21 U.S.C. (Pub. L. 112–144). A device sponsor reducing regulatory burdens. When FDA 360c(a)(1)(B)). After review of the may utilize either procedure for De classifies a device into class I or II via information submitted in the request, Novo classification. the De Novo process, the device can we determined that the device can be Under the first procedure, the person serve as a predicate for future devices of classified into class II with the submits a 510(k) for a device that has that type, including for 510(k)s (see 21 establishment of special controls. FDA not previously been classified. After U.S.C. 360c(f)(2)(B)(i)). As a result, other has determined that these special receiving an order from FDA classifying device sponsors do not have to submit controls, in addition to the general the device into class III under section a De Novo request or premarket controls, will provide reasonable 513(f)(1) of the FD&C Act, the person approval application in order to market assurance of the safety and effectiveness then requests a classification under a substantially equivalent device (see 21 of the device. section 513(f)(2). U.S.C. 360c(i), defining ‘‘substantial Therefore, on December 20, 2016, equivalence’’). Instead, sponsors can use Under the second procedure, rather FDA issued an order to the requester the less-burdensome 510(k) process, than first submitting a 510(k) and then classifying the device into class II. FDA when necessary, to market their device. a request for classification, if the person is codifying the classification of the determines that there is no legally II. De Novo Classification device by adding 21 CFR 878.5050. We marketed device upon which to base a On May 26, 2015, Alesi Surgical have named the generic type of device determination of substantial submitted a request for De Novo surgical smoke precipitator, and it is equivalence, that person requests a classification of the UltravisionTM identified as a prescription device classification under section 513(f)(2) of Visual Field Clearing System. FDA intended for clearance of the visual field the FD&C Act. reviewed the request in order to classify by precipitation of surgical smoke and Under either procedure for De Novo the device under the criteria for other aerosolized particulate matter classification, FDA shall classify the classification set forth in section created during laparoscopic surgery. device by written order within 120 days. 513(a)(1) of the FD&C Act. FDA has identified the following risks The classification will be according to We classify devices into class II if to health associated specifically with the criteria under section 513(a)(1) of general controls by themselves are this type of device and the measures the FD&C Act. Although the device was insufficient to provide reasonable required to mitigate these risks in table automatically placed within class III, assurance of safety and effectiveness, 1. TABLE 1—SURGICAL SMOKE PRECIPITATOR RISKS AND MITIGATION MEASURES Identified risks Mitigation measures Electrical shock ......................................................................................... Electrical safety testing and Labeling. Electromagnetic interference with other devices ..................................... Electromagnetic compatibility testing and Labeling. Infection .................................................................................................... Sterilization validation, Shelf-life validation, and Labeling. Adverse tissue reaction ............................................................................ Biocompatibility evaluation. Tissue injury ............................................................................................. Animal testing; Software verification, validation, and hazard analysis; and Labeling. FDA has determined that special 21 CFR 801.109 are met (referring to 21 the guidance document ‘‘De Novo controls, in combination with the U.S.C. 352(f)(1)). Classification Process (Evaluation of general controls, address these risks to III. Analysis of Environmental Impact Automatic Class III Designation)’’ have health and provide reasonable assurance been approved under OMB control of safety and effectiveness. For a device The Agency has determined under 21 number 0910–0844; the collections of to fall within this classification, and CFR 25.34(b) that this action is of a type information in 21 CFR part 814, thus avoid automatic classification in that does not individually or subparts A through E, regarding class III, it would have to comply with cumulatively have a significant effect on premarket approval, have been the special controls named in this final the human environment. Therefore, neither an environmental assessment approved under OMB control number order. The necessary special controls 0910–0231; the collections of appear in the regulation codified by this nor an environmental impact statement is required. information part 807, subpart E, order. This device is subject to regarding premarket notification premarket notification requirements IV. Paperwork Reduction Act of 1995 submissions, have been approved under under section 510(k) of the FD&C Act. This final order establishes special OMB control number 0910–0120, and At the time of classification, surgical controls that refer to previously the collections of information in 21 CFR rmajette on DSKBCKNHB2PROD with RULES smoke precipitators are for prescription approved collections of information part 801, regarding labeling, have been use only. Prescription devices are found in other FDA regulations. These approved under OMB control number exempt from the requirement for collections of information are subject to 0910–0485. adequate directions for use for the review by the Office of Management and layperson under section 502(f)(1) of the Budget (OMB) under the Paperwork List of Subjects in 21 CFR Part 878 FD&C Act (21 U.S.C. 352(f)(1)) and 21 Reduction Act of 1995 (44 U.S.C. 3501– Medical devices. CFR 801.5, as long as the conditions of 3520). The collections of information in VerDate Sep<11>2014 15:14 Jan 29, 2018 Jkt 244001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 E:\FR\FM\30JAR1.SGM 30JAR1

Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Rules and Regulations 4143 Therefore, under the Federal Food, (iii) A shelf life. PART 51—PASSPORTS Drug, and Cosmetic Act and under Dated: January 24, 2018. authority delegated to the Commissioner ■ Accordingly, the interim final rule Leslie Kux, of Food and Drugs, 21 CFR part 878 is amending 22 CFR part 51, which was Associate Commissioner for Policy. published at 81 FR 67156 on September amended as follows: [FR Doc. 2018–01639 Filed 1–29–18; 8:45 am] 30, 2016, is adopted as a final rule PART 878—GENERAL AND PLASTIC BILLING CODE 4164–01–P without change. SURGERY DEVICES Carl C. Risch, ■ 1. The authority citation for part 878 Assistant Secretary, Consular Affairs. continues to read as follows: DEPARTMENT OF STATE [FR Doc. 2018–01708 Filed 1–29–18; 8:45 am] Authority: 21 U.S.C. 351, 360, 360c, 360e, 22 CFR Part 51 BILLING CODE 4710–06–P 360j, 360l, 371. ■ 2. Add § 878.5050 to subpart F to read [Public Notice: 9867] as follows: DEPARTMENT OF HOMELAND RIN 1400–AE01 SECURITY § 878.5050 Surgical smoke precipitator. (a) Identification. A surgical smoke Passports: Service Passports Coast Guard precipitator is a prescription device intended for clearance of the visual field AGENCY: Department of State. 33 CFR Part 117 by precipitation of surgical smoke and ACTION: Final rule. [Docket No. USCG–2018–0025] other aerosolized particulate matter created during laparoscopic surgery. SUMMARY: This rule finalizes the interim Drawbridge Operation Regulation; (b) Classification. Class II (special final rule from the Department of State Willamette River, Portland, OR controls). The special controls for this that established a new service passport, device are: which may be approved for certain non- AGENCY: Coast Guard, DHS. (1) Adverse tissue reaction must be personal services contractors who travel ACTION:Notice of deviation from mitigated through the following: abroad in support of and pursuant to a drawbridge regulation. (i) Chemical characterization and contract with the U.S. government. The toxicological risk assessment of the Department received no public SUMMARY: The Coast Guard has issued a treated surgical smoke. comments in response to the rule. temporary deviation from the operating (ii) Demonstration that the elements DATES: Effective January 30, 2018. schedule that governs the Broadway of the device that may contact the Bridge across the Willamette River, mile FOR FURTHER INFORMATION CONTACT: patient are biocompatible. 11.7, at Portland, OR. The deviation is Sitara Kedilaya, Attorney-Adviser, (2) Electrical safety and necessary to make adjustments to new PassportRules@state.gov, (202) 485– electromagnetic compatibility testing equipment. This deviation allows the 6500. must demonstrate that the device bridge to operate the double bascule performs as intended. SUPPLEMENTARY INFORMATION: On span one side at a time, single leaf. (3) Software verification, validation, September 30, 2016, the Department DATES: This deviation is effective and hazard analysis must be performed. published an interim final rule without actual notice from January 30, (4) Performance data must amending 22 CFR part 51, to create a 2018, to 11:59 p.m. on February 23, demonstrate the sterility of the patient ‘‘service passport’’ that would be used 2018. For the purposes of enforcement, contacting components of the device. by non-personal services contractors to actual notice will be used from 1 a.m. (5) Performance data must support the carry out critical security, maintenance on January 27, 2018, through January shelf life of the sterile components of and other functions on behalf of the U.S. 30, 2018. the device by demonstrating continued government. As noted in the interim ADDRESSES: The docket for this functionality, sterility, and package final rule, the Department estimates that deviation, USCG–2018–0025, is integrity over the identified shelf life. this rulemaking will affect available at http://www.regulations.gov. (6) Animal simulated-use testing must approximately 1,000 non-personal Type the docket number in the demonstrate that the device performs as services contractors per year. Further ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ intended under anticipated conditions information concerning the rationale for Click on Open Docket Folder on the line of use. The following performance this rule can be found in the interim associated with this deviation. characteristics must be tested: final rule. The Department provided 60 days for FOR FURTHER INFORMATION CONTACT: If (i) Device must be demonstrated to be effectively inserted, positioned, and the public to comment on this rule. This you have questions on this temporary removed from the site of use. period expired on November 29, 2016. deviation, call or email Mr. Steven (ii) Device must be demonstrated to The Department received no public Fischer, Bridge Administrator, precipitate surgical smoke particulates comments. Thirteenth Coast Guard District; to clear the visual field for laparoscopic The Regulatory Findings included telephone 206–220–7282, email surgeries. with the interim final rule are Steven.M.Fischer@uscg.mil. (iii) Device must be demonstrated to incorporated herein. This rule is not an SUPPLEMENTARY INFORMATION: be non-damaging to the site of use and E.O. 13771 regulatory action because it Multnomah County, the bridge owner, rmajette on DSKBCKNHB2PROD with RULES animal subject. is not significant under E.O. 12866. requested the Broadway Bridge be (7) Labeling must identify the authorized to open half the span in List of Subjects in 22 CFR Part 51 single leaf mode to make adjustments to following: (i) Detailed instructions for use. Administrative practice and newly installed equipment. The (ii) Electrical safety and procedure, Drug traffic control, Broadway Bridge crosses the Willamette electromagnetic compatibility Passports and visas, Reporting and River at mile 11.7, and provides 90 feet information. recordkeeping requirements. of vertical clearance above Columbia VerDate Sep<11>2014 15:14 Jan 29, 2018 Jkt 244001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\30JAR1.SGM 30JAR1


Document Created: 2018-10-26 10:11:49
Document Modified: 2018-10-26 10:11:49
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal order.
DatesThis order is effective January 30, 2018. The classification was applicable on December 20, 2016.
ContactSteven Elliott, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2565, Silver Spring, MD 20993-0002, 301-796-5285, [email protected]
FR Citation83 FR 4141 
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