80 FR 58603 - Medical Devices; Cardiovascular Devices; Classification of the Steerable Cardiac Ablation Catheter Remote Control System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 189 (September 30, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 189 (September 30, 2015)
| Page Range | 58603-58607 | |
| FR Document | 2015-24624 |
[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)] [Rules and Regulations] [Pages 58603-58607] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24624] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2015-N-3165] Medical Devices; Cardiovascular Devices; Classification of the Steerable Cardiac Ablation Catheter Remote Control System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the steerable cardiac ablation catheter remote control system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the steerable cardiac ablation catheter remote control system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective September 30, 2015. The classification was applicable on December 18, 2014. FOR FURTHER INFORMATION CONTACT: Deborah Castillo, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1321, Silver Spring, MD 20993-0002, 301- 796-4908. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless, and until, the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate [[Page 58604]] device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112- 144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1) of the FD&C Act. Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of ``low-moderate risk'' or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. On February 14, 2014, Catheter Robotics, Inc. submitted a request for classification of the AMIGO Remote Catheter System under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1). In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies 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 to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on December 18, 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 870.5700. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a steerable cardiac ablation catheter remote control system will need to comply with the special controls named in this final order. The device is assigned the generic name steerable cardiac ablation catheter remote control system, and it is identified as a prescription device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a compatible, steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure. FDA has identified the following risks to health associated specifically with this type of device, as well as the mitigation measures required to mitigate these risks in table 1. Table 1--Steerable Cardiac Ablation Catheter Remote Control System Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation measure ------------------------------------------------------------------------ Device Failure, Resulting in Patient Non-Clinical Mechanical Injury or Interruption of Procedure. Performance Testing Non-Clinical Electrical Testing: Electromagnetic Compatibility (EMC), Electrical Safety, Electrical System, Performance, Shelf Life Testing, Sterilization Testing, In Vivo Testing, Labeling, Training. Device Alters Catheter Functionality Non-Clinical Mechanical (Advance/Withdrawal, Rotation, Performance Testing Deflection) Resulting in Patient Non-Clinical Electrical Injury (e.g., Perforation) or Improper Testing: EMC, Electrical Catheter Performance (Positioning and Safety, Electrical System, Contact) or Interruption of Procedure. Performance, In Vivo Testing, Labeling, Post Market Surveillance. Adverse Tissue Reaction................ Sterilization Testing. Improper Device Use/Use Error.......... Labeling, Training, In Vivo Testing, Post Market Surveillance. Interference with Other Electrical Non-Clinical Mechanical Equipment/Devices (e.g., Device Performance Testing Malfunction). Non-Clinical Electrical Testing: EMC, Electrical Safety, Electrical System, Performance, Labeling. Electrical Shock....................... Non-Clinical Electrical Testing: Electrical Safety Testing, Labeling. Device Malfunction Resulting in Non-Clinical Mechanical Unanticipated Operation (e.g., Device Performance Testing Stoppage, Unintended Movement). Non-Clinical Electrical Testing: EMC, Electrical Safety, Electrical System, Performance, In Vivo Testing, Labeling, Training. ------------------------------------------------------------------------ FDA believes that the following special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness:Non-clinical mechanical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance testing must be performed: [cir] Mechanical performance of the system (without catheter connected); [cir] mechanical performance of the system with compatible catheters connected to verify that the system does not impact catheter function or [[Page 58605]] performance. Assessments must include the following: [ssquf] Side-by side remote control and manual comparisons of catheter manipulation (including all ranges of motion of catheter deflection and tip curl) for all compatible catheters; must include testing for worst-case conditions, and [ssquf] evaluation of the accuracy and function of all device control safety features; and [cir] simulated-use testing in a bench anatomic model or animal model. Non-clinical electrical testing must include validation of EMC, electrical safety, thermal safety, and electrical system performance. The following performance testing must be performed: [cir] Electrical performance of the system with compatible catheters connected to verify that the system does not impact catheter function or performance. Assessments must include the following: [ssquf] Side-by side remote control and manual comparisons of catheter manipulation (including all ranges of motion of catheter deflection and tip curl) for all compatible catheters; must include testing for worst-case conditions, and [ssquf] evaluation of the accuracy and function of all device control safety features; and [cir] electrical safety between the device and ablation catheter system and with other electrical equipment expected in the catheter lab or operating room. In vivo testing must demonstrate that the device performs as intended under anticipated conditions of use, including an assessment of the system impact on the functionality and performance of compatible catheters, and documentation of the adverse event profile associated with clinical use. Evidence must be submitted to address the following: [cir] Manipulation and positioning: Ability to manipulate compatible catheters to pre-specified cardiac locations and confirm proper anatomic placement and tissue contact, in accordance with the system indications for use and the compatible catheter indications for use; [cir] Safety: Assess device-related complication rate and major procedural complication rate (regardless of device relatedness) in comparison to literature and/or a manual comparison group for compatible ablation catheters to support the indications for use; [cir] Efficacy: Assess ablation success in comparison to literature and/or a manual comparison group for compatible ablation catheters to support the indications for use; and [cir] User assessment of device remote controls and safety features. Post-market surveillance (PMS) must be conducted and completed in accordance with FDA-agreed upon PMS protocol. A training program must be included with sufficient educational elements that, upon completion of the training program, the clinician and supporting staff can [cir] Identify the safe environments for device use, [cir] use all safety features of device, and [cir] operate the device in simulated or actual use environments representative of indicated environments and use for the indication of compatible catheters. Performance data must demonstrate the sterility of the sterile disposable components of the system. Performance data must support shelf life by demonstrating continued sterility of the device (of the sterile disposable components), package integrity, and device functionality over the requested shelf life. Labeling must include the following: [cir] Appropriate instructions, warnings, cautions, limitations, and information related to the intended patient population, compatible ablation catheters, and the device safeguards for the safe use of the device; [cir] specific instructions and the clinical training needed for the safe use of the device, which includes: [ssquf] instructions on assembling the device in all available configurations, including installation and removal of compatible catheters; [ssquf] instructions and explanation of all controls, inputs, and outputs; [ssquf] instructions on all available modes or states of the device; [ssquf] instructions on all safety features of the device; and [ssquf] validated methods and instructions for reprocessing/ disinfecting any reusable components; [cir] a detailed summary of the mechanical compatibility testing including: [ssquf] A table with a complete list of compatible catheters tested (manufacturer trade name and model number), and [ssquf] a table with detailed test results, including type of test, acceptance criteria, and test results (i.e., pass for meeting acceptance criteria); [cir] a detailed summary of the in vivo testing including: [ssquf] a table with a complete list of compatible catheters used during testing (manufacturer trade name and model number); [ssquf] adverse events encountered pertinent to use of the device under use conditions; [ssquf] a detailed summary of the device- and procedure-related complications; and [ssquf] a summary of study outcomes and endpoints. Information pertinent to the fluoroscopy times/exposure for the procedure, patient and operator fluoroscopic exposure; [cir] other labeling items: [ssquf] a detailed summary of pertinent non-clinical testing information: EMC, mechanical, electrical, and sterilization of device and components; [ssquf] a detailed summary of the device technical parameters; and [ssquf] an expiration date/shelf life and storage conditions for the sterile accessories; and [cir] when available, and according to the timeframe included in the PMS protocol agreed upon with FDA, provide a detailed summary of the PMS data including: [ssquf] Updates to the labeling to accurately reflect outcomes or necessary modifications based upon data collected during the PMS experience, and [ssquf] inclusion of results and adverse events associated with utilization of the device during the PMS. The steerable cardiac ablation catheter remote control system is a prescription device restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; see 21 CFR 801.109 (Prescription devices). Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the steerable cardiac ablation catheter remote control system they intend to market. II. Environmental Impact The Agency has determined under 21 CFR 25.33(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 [[Page 58606]] nor an environmental impact statement is required. III. 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 21 CFR part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485; and the collections of information in 21 CFR part 820, regarding postmarket surveillance, have been approved under OMB control number 0910-0449. IV. Reference The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at http://www.regulations.gov. 1. DEN140009: De Novo Request from Catheter Robotics, Inc., dated February 14, 2014. List of Subjects in 21 CFR Part 870 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 870 is amended as follows: PART 870--CARDIOVASCULAR DEVICES 0 1. The authority citation for 21 CFR part 870 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 0 2. Add Sec. 870.5700 to subpart F to read as follows: Sec. 870.5700 Steerable cardiac ablation catheter remote control system. (a) Identification. A steerable cardiac ablation catheter remote control system is a prescription device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a compatible, steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure. (b) Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical mechanical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance testing must be performed: (i) Mechanical performance of the system (without catheter connected); (ii) Mechanical performance of the system with compatible catheters connected to verify that the system does not impact catheter function or performance. Assessments must include the following: (A) Side-by-side remote control and manual comparisons of catheter manipulation (including all ranges of motion of catheter deflection and tip curl) for all compatible catheters; must include testing for worst- case conditions, and (B) Evaluation of the accuracy and function of all device control safety features; and (iii) Simulated-use testing in a bench anatomic model or animal model. (2) Non-clinical electrical testing must include validation of electromagnetic compatibility (EMC), electrical safety, thermal safety, and electrical system performance. The following performance testing must be performed: (i) Electrical performance of the system with compatible catheters connected to verify that the system does not impact catheter function or performance. Assessments must include the following: (A) Side-by-side remote control and manual comparisons of catheter manipulation (including all ranges of motion of catheter deflection and tip curl) for all compatible catheters; must include testing for worst- case conditions, and (B) Evaluation of the accuracy and function of all device control safety features; and (ii) Electrical safety between the device and ablation catheter system and with other electrical equipment expected in the catheter lab or operating room. (3) In vivo testing must demonstrate that the device performs as intended under anticipated conditions of use, including an assessment of the system impact on the functionality and performance of compatible catheters, and documentation of the adverse event profile associated with clinical use. Evidence must be submitted to address the following: (i) Manipulation and Positioning: Ability to manipulate compatible catheters to pre-specified cardiac locations and confirm proper anatomic placement and tissue contact, in accordance with the system indications for use and the compatible catheter indications for use; (ii) Safety: Assess device-related complication rate and major procedural complication rate (regardless of device relatedness) in comparison to literature and/or a manual comparison group for compatible ablation catheters to support the indications for use; (iii) Efficacy: Assess ablation success in comparison to literature and/or a manual comparison group for compatible ablation catheters to support the indications for use; and (iv) User assessment of device remote controls and safety features. (4) Post-market surveillance (PMS) must be conducted and completed in accordance with FDA agreed upon PMS protocol. (5) A training program must be included with sufficient educational elements that, upon completion of the training program, the clinician and supporting staff can: (i) Identify the safe environments for device use, (ii) Use all safety features of device, and (iii) Operate the device in simulated or actual use environments representative of indicated environments and use for the indication of compatible catheters. (6) Performance data must demonstrate the sterility of the sterile disposable components of the system. (7) Performance data must support shelf life by demonstrating continued sterility of the device (of the sterile disposable components), package integrity, and device functionality over the requested shelf life. (8) Labeling must include the following: (i) Appropriate instructions, warnings, cautions, limitations, and information related to the intended patient population, compatible ablation catheters, and the device safeguards for the safe use of the device; (ii) Specific instructions and the clinical training needed for the safe use of the device, which includes: (A) Instructions on assembling the device in all available configurations, including installation and removal of compatible catheters; (B) Instructions and explanation of all controls, inputs, and outputs; [[Page 58607]] (C) Instructions on all available modes or states of the device; (D) Instructions on all safety features of the device; and (E) Validated methods and instructions for reprocessing/ disinfecting any reusable components; (iii) A detailed summary of the mechanical compatibility testing including: (A) A table with a complete list of compatible catheters tested (manufacturer trade name and model number), and (B) A table with detailed test results, including type of test, acceptance criteria, and test results (i.e., pass for meeting acceptance criteria); (iv) A detailed summary of the in vivo testing including: (A) A table with a complete list of compatible catheters used during testing (manufacturer trade name and model number); (B) Adverse events encountered pertinent to use of the device under use conditions; (C) A detailed summary of the device- and procedure-related complications; and (D) A summary of study outcomes and endpoints. Information pertinent to the fluoroscopy times/exposure for the procedure, patient, and operator fluoroscopic exposure; (v) Other labeling items: (A) A detailed summary of pertinent non-clinical testing information: EMC, mechanical, electrical, and sterilization of device and components; (B) A detailed summary of the device technical parameters; and (C) An expiration date/shelf life and storage conditions for the sterile accessories; and (vi) When available, and according to the timeframe included in the PMS protocol agreed upon with FDA, provide a detailed summary of the PMS data including: (A) Updates to the labeling to accurately reflect outcomes or necessary modifications based upon data collected during the PMS experience, and (B) Inclusion of results and adverse events associated with utilization of the device during the PMS. Dated: September 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-24624 Filed 9-29-15; 8:45 am] BILLING CODE 4164-01-P
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CONFIDENTIAL INFORMATION’’. The finalized. The guidance announced in Dated: September 23, 2015.
Agency will review this copy, including this notice finalizes the draft guidance Leslie Kux,
the claimed confidential information, in dated June 2015. This guidance also Associate Commissioner for Policy.
its consideration of comments. The serves as a Small Entity Compliance [FR Doc. 2015–24685 Filed 9–29–15; 8:45 am]
second copy, which will have the Guide (SECG) to aid industry in BILLING CODE 4164–01–P
claimed confidential information complying with the requirements of the
redacted/blacked out, will be available VFD final rule that published in the
for public viewing and posted on http:// Federal Register on June 3, 2015 (80 FR DEPARTMENT OF HEALTH AND
www.regulations.gov. Submit both 31708). FDA has prepared this SECG in HUMAN SERVICES
copies to the Division of Dockets accordance with section 212 of the
Management. If you do not wish your Small Business Regulatory Enforcement Food and Drug Administration
name and contact information to be Fairness Act (Pub. L. 104–121). This
made publicly available, you can document is intended to provide 21 CFR Part 870
provide this information on the cover guidance to small businesses on the [Docket No. FDA–2015–N–3165]
sheet and not in the body of your requirements of the final rule.
comments and you must identify this In 1996, Congress enacted the Animal Medical Devices; Cardiovascular
information as ‘‘confidential.’’ Any Drug Availability Act (ADAA) to Devices; Classification of the Steerable
information marked as ‘‘confidential’’ facilitate the approval and marketing of Cardiac Ablation Catheter Remote
will not be disclosed except in new animal drugs and medicated feeds. Control System
accordance with 21 CFR 10.20 and other In passing the ADAA, Congress created
applicable disclosure law. For more a new regulatory category for certain AGENCY: Food and Drug Administration,
information about FDA’s posting of animal drugs used in animal feed called HHS.
comments to public dockets, see 80 FR VFD drugs. VFD drugs are new animal ACTION: Final order.
56469, September 18, 2015, or access drugs intended for use in or on animal
the information at: http://www.fda.gov/ feed which are limited to use under the SUMMARY: The Food and Drug
regulatoryinformation/dockets/ professional supervision of a licensed Administration (FDA) is classifying the
default.htm. veterinarian. FDA published final steerable cardiac ablation catheter
Docket: For access to the docket to regulations implementing the VFD- remote control system into class II
read background documents or the related provisions of the ADAA in 2000. (special controls). The special controls
electronic and written/paper comments On June 3, 2015, FDA published a VFD that will apply to the device are
received, go to http:// final rule that revised those VFD identified in this order and will be part
www.regulations.gov and insert the regulations and introduced clarifying of the codified language for the steerable
docket number, found in brackets in the changes to specified definitions, and cardiac ablation catheter remote control
heading of this document, into the published the draft revised guidance for system’s classification. The Agency is
‘‘Search’’ box and follow the prompts comment. classifying the device into class II
and/or go to the Division of Dockets (special controls) in order to provide a
Management, 5630 Fishers Lane, Rm. II. Significance of Guidance reasonable assurance of safety and
1061, Rockville, MD 20852. effectiveness of the device.
This guidance is being issued
Submit written requests for single consistent with FDA’s good guidance DATES: This order is effective September
copies of the guidance to the Policy and practices regulation (21 CFR 10.115). 30, 2015. The classification was
Regulations Staff (HFV–6), Center for The guidance represents the current applicable on December 18, 2014.
Veterinary Medicine, Food and Drug thinking of FDA on VFD regulation FOR FURTHER INFORMATION CONTACT:
Administration, 7519 Standish Pl., questions and answers. It does not Deborah Castillo, Center for Devices and
Rockville, MD 20855. Send one self- establish any rights for any person and Radiological Health, Food and Drug
addressed adhesive label to assist that is not binding on FDA or the public. Administration, 10903 New Hampshire
office in processing your requests. See You can use an alternative approach if Ave., Bldg. 66, Rm. 1321, Silver Spring,
the SUPPLEMENTARY INFORMATION section it satisfies the requirements of the MD 20993–0002, 301–796–4908.
for electronic access to the guidance applicable statutes and regulations. SUPPLEMENTARY INFORMATION:
document.
III. Paperwork Reduction Act of 1995 I. Background
FOR FURTHER INFORMATION CONTACT:
Dragan Momcilovic, Center for This guidance refers to previously In accordance with section 513(f)(1) of
Veterinary Medicine (HFV–226), Food approved collections of information the Federal Food, Drug, and Cosmetic
and Drug Administration, 7519 Standish found in FDA regulations. These Act (the FD&C Act) (21 U.S.C.
Pl., Rockville, MD 20855, 240–402– collections of information are subject to 360c(f)(1)), devices that were not in
5944, dragan.momcilovic@fda.hhs.gov. review by the Office of Management and commercial distribution before May 28,
SUPPLEMENTARY INFORMATION: Budget (OMB) under the Paperwork 1976 (the date of enactment of the
Reduction Act of 1995 (44 U.S.C. 3501– Medical Device Amendments of 1976),
I. Background 3520). The collections of information in generally referred to as postamendments
In the Federal Register of June 3, 2015 21 CFR 558.6 have been approved under devices, are classified automatically by
(80 FR 31520), FDA published a notice OMB control number 0910–0363. statute into class III without any FDA
of availability for a draft guidance rulemaking process. These devices
IV. Electronic Access
mstockstill on DSK4VPTVN1PROD with RULES
entitled ‘‘Veterinary Feed Directive remain in class III and require
Regulation Questions and Answers’’ Persons with access to the Internet premarket approval, unless, and until,
giving interested persons until August 3, may obtain the guidance at either http:// the device is classified or reclassified
2015, to comment on the draft guidance. www.fda.gov/AnimalVeterinary/ into class I or II, or FDA issues an order
FDA received several comments on the GuidanceComplianceEnforcement/ finding the device to be substantially
draft guidance and those comments GuidanceforIndustry/default.htm or equivalent, in accordance with section
were considered as the guidance was http://www.regulations.gov. 513(i) of the FD&C Act, to a predicate
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(C) Instructions on all available modes DEPARTMENT OF DEFENSE • Federal Rulemaking Portal: http://
or states of the device; www.regulations.gov. Follow the
(D) Instructions on all safety features Office of the Secretary instructions for submitting comments.
of the device; and • Mail: Department of Defense, Office
32 CFR Part 311
(E) Validated methods and of the Deputy Chief Management
instructions for reprocessing/ Officer, Directorate of Oversight and
[Docket ID: DoD–2015–OS–0077] Compliance, Regulatory and Audit
disinfecting any reusable components;
Matters Office, 9010 Defense Pentagon,
(iii) A detailed summary of the Privacy Act of 1974; Implementation
Washington, DC 20301–9010.
mechanical compatibility testing
including: Office of the Secretary, DoD.
AGENCY: Instructions: All submissions received
Direct final rule with request for
ACTION: must include the agency name and
(A) A table with a complete list of
comments. docket number for this Federal Register
compatible catheters tested
(manufacturer trade name and model document. The general policy for
SUMMARY: The Office of the Secretary of comments and other submissions from
number), and Defense (OSD) is exempting those members of the public is to make these
(B) A table with detailed test results, records contained in DPFPA 07, entitled submissions available for public
including type of test, acceptance ‘‘Counterintelligence Management viewing on the Internet at http://
criteria, and test results (i.e., pass for Information System (CIMIS),’’ www.regulations.gov as they are
meeting acceptance criteria); pertaining to investigatory material received without change, including any
(iv) A detailed summary of the in vivo compiled for counterintelligence and personal identifiers or contact
testing including: law enforcement purposes (under (k)(2) information.
of the Act), other than material within
(A) A table with a complete list of the scope of subsection (j)(2) of the FOR FURTHER INFORMATION CONTACT: Ms.
compatible catheters used during testing Privacy Act to enable the protection of Cindy Allard at (571) 372–0461.
(manufacturer trade name and model identities of confidential sources who
number); SUPPLEMENTARY INFORMATION: This
might not otherwise come forward and
(B) Adverse events encountered direct final rule makes changes to the
who furnished information under an
pertinent to use of the device under use express promise that the sources’ Office of the Secretary Privacy Program
conditions; identity would be held in confidence. rules. These changes will allow the
The exemption will allow DoD to Department to add an exemption rule to
(C) A detailed summary of the device- the Office of the Secretary of Defense
and procedure-related complications; provide protection against notification
of investigatory material including Privacy Program rules that will exempt
and applicable Department records and/or
certain reciprocal investigations which
(D) A summary of study outcomes and material from certain portions of the
might alert a subject to the fact that an
endpoints. Information pertinent to the Privacy Act.
investigation of that individual is taking
fluoroscopy times/exposure for the This rule is being published as a
place, and the disclosure of which
procedure, patient, and operator direct final rule as the Department of
would weaken the on-going
fluoroscopic exposure; Defense does not expect to receive any
investigation, reveal investigatory
(v) Other labeling items: techniques, and place confidential adverse comments, and so a proposed
(A) A detailed summary of pertinent informants in jeopardy who furnished rule is unnecessary.
non-clinical testing information: EMC, information under an express promise
that the sources’ identity would be held Direct Final Rule and Significant
mechanical, electrical, and sterilization Adverse Comments
of device and components; in confidence. Further, requiring OSD to
grant access to records and amend these DoD has determined this rulemaking
(B) A detailed summary of the device
records would unfairly impede the meets the criteria for a direct final rule
technical parameters; and
investigation of allegations of unlawful because it involves non-substantive
(C) An expiration date/shelf life and activities. To require OSD to confirm or changes dealing with DoD’s
storage conditions for the sterile deny the existence of a record management of its Privacy Programs.
accessories; and pertaining to a requesting individual DoD expects no opposition to the
(vi) When available, and according to may in itself provide an answer to that changes and no significant adverse
the timeframe included in the PMS individual relating to an on-going comments. However, if DoD receives a
protocol agreed upon with FDA, provide investigation. The investigation of significant adverse comment, the
a detailed summary of the PMS data possible unlawful activities would be Department will withdraw this direct
including: jeopardized by agency rules requiring final rule by publishing a notice in the
(A) Updates to the labeling to verification of record, disclosure of the Federal Register. A significant adverse
accurately reflect outcomes or necessary record to the subject, and record comment is one that explains: (1) Why
modifications based upon data collected amendment procedures. the direct final rule is inappropriate,
during the PMS experience, and DATES: The rule will be effective on including challenges to the rule’s
December 9, 2015 unless adverse underlying premise or approach; or (2)
(B) Inclusion of results and adverse
comments are received by November 30, why the direct final rule will be
events associated with utilization of the
mstockstill on DSK4VPTVN1PROD with RULES
2015. If adverse comment is received, ineffective or unacceptable without a
device during the PMS.
the Department of Defense will publish change. In determining whether a
Dated: September 23, 2015. a timely withdrawal of the rule in the comment necessitates withdrawal of
Leslie Kux, Federal Register. this direct final rule, DoD will consider
Associate Commissioner for Policy. ADDRESSES: You may submit comments, whether it warrants a substantive
[FR Doc. 2015–24624 Filed 9–29–15; 8:45 am] identified by docket number and title, response in a notice and comment
BILLING CODE 4164–01–P by any of the following methods: process.
VerDate Sep<11>2014 17:12 Sep 29, 2015 Jkt 235001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\FR\FM\30SER1.SGM 30SER1](https://thefederalregister.org/doc/80_FR_58792/page/5.svg)
Document Created: 2015-12-15 09:31:59
Document Modified: 2015-12-15 09:31:59
| 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 September 30, 2015. The classification was applicable on December 18, 2014. | |
| Contact | Deborah Castillo, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1321, Silver Spring, MD 20993-0002, 301- 796-4908. | |
| FR Citation | 80 FR 58603 |
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