81 FR 64761 - Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 183 (September 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 183 (September 21, 2016)
| Page Range | 64761-64763 | |
| FR Document | 2016-22709 |
[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)] [Rules and Regulations] [Pages 64761-64763] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22709] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2016-N-2562] Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument 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 magnetic surgical instrument 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 21, 2016. The classification was applicable on June 13, 2016. FOR FURTHER INFORMATION CONTACT: Varun Pattani, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G452, Silver Spring, MD, 20993-0002, 301-796-6368, [email protected]. 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 [[Page 64762]] 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), to a predicate 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 shall classify the device by written order within 120 days. This classification will be the initial classification of the device. On February 9, 2015, Levita Magnetics International Corp., submitted a request for classification of the Levita Magnetic Surgical System under section 513(f)(2) of the FD&C Act. 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) of the FD&C Act. 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 June 13, 2016, 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 878.4815. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a magnetic surgical instrument system will need to comply with the special controls named in this final order. The device is assigned the generic name magnetic surgical instrument system, and it is identified as a prescription device used in laparoscopic surgical procedures consisting of several components, such as surgical instruments, and a magnetic controller. The magnetic controller is provided separately from the surgical instrument and is used outside the patient. The external magnetic controller is magnetically coupled with the internal surgical instrument(s) at the surgical site to grasp, hold, retract, mobilize, or manipulate soft tissue and organs. 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--Magnetic Surgical Instrument System Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation measures ------------------------------------------------------------------------ Tissue Damage................................ In vivo Performance Testing. Human Factors Testing and Analysis. Training. Labeling. Need for Extended or Additional Surgery: In vivo PerformanceInability to couple the external Testing. magnet with the internal surgical instrument Non-clinical Performance Inability to retrieve or maneuver Testing. device Human Factors Testing and Inability to visualize critical Analysis. anatomical structures Training. Labeling. Abdominal Wall Injury........................ In vivo Performance Testing. Human Factors Testing and Analysis. Labeling. Electromagnetic Field Incompatibility or Non-clinical Performance Interference (including ferromagnetic Testing. implants in users and patients, electrosurgical devices, etc.). Human Factors Testing and Analysis. Training. Labeling. Adverse Tissue Reaction...................... Biocompatibility Evaluation. Infection.................................... Sterilization Validation. Reprocessing Validation. Shelf Life Validation. Labeling. ------------------------------------------------------------------------ [[Page 64763]] FDA believes that the special controls, in addition to the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness. A magnetic surgical instrument system device is not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (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) of the FD&C Act, 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 magnetic surgical instrument system they intend to market. II. 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. 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 part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 878 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows: PART 878--GENERAL AND PLASTIC SURGERY DEVICES 0 1. The authority citation for part 878 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 878.4815 to subpart E to read as follows: Sec. 878.4815 Magnetic surgical instrument system. (a) Identification. A magnetic surgical instrument system is a prescription device used in laparoscopic surgical procedures consisting of several components, such as surgical instruments, and a magnetic controller. The magnetic controller is provided separately from the surgical instrument and is used outside the patient. The external magnetic controller is magnetically coupled with the internal surgical instrument(s) at the surgical site to grasp, hold, retract, mobilize, or manipulate soft tissue and organs. (b) Classification. Class II (special controls). The special controls for this device are: (1) In vivo performance data must demonstrate that the device performs as intended under anticipated conditions of use. Testing must demonstrate the ability of the device to grasp, hold, retract, mobilize, or manipulate soft tissue and organs. (2) Non-clinical performance data must demonstrate that the system performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Magnetic field strength testing characterization to identify the distances from the magnet that are safe for patients and users with ferromagnetic implants, devices, or objects. (ii) Ability of the internal surgical instrument(s) to be coupled, de-coupled, and re-coupled with the external magnet over the external magnet use life. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of the device components that are patient-contacting. (5) Methods and instructions for reprocessing reusable components must be validated. (6) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components and device functionality over the labeled shelf life. (7) Training must be developed and validated by human factors testing and analysis to ensure users can follow the instructions for use to allow safe use of the device. (8) Labeling must include: (i) Magnetic field safe zones. (ii) Instructions for proper device use. (iii) A screening checklist to ensure that all patients and operating staff are screened from bringing ferromagnetic implants, devices, or objects near the external magnet. (iv) Reprocessing instructions for any reusable components. (v) Shelf life. (vi) Use life. Dated: September 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22709 Filed 9-20-16; 8:45 am] BILLING CODE 4164-01-P
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considering several factors including the information technologies to provide § 987.339 Assessment rate.
anticipated 2016–17 crop size, the increased opportunities for citizen On and after October 1, 2016, an
committee’s estimates of the incoming access to Government information and assessment rate of $0.05 per
reserve funds and other income, and its services, and for other purposes. hundredweight is established for dates
anticipated expenses. USDA has not identified any relevant produced or packed in Riverside
A review of historical and preliminary Federal rules that duplicate, overlap, or County, California.
information pertaining to the upcoming conflict with this rule. Dated: September 16, 2016.
crop year indicates that the producer A small business guide on complying
with fruit, vegetable, and specialty crop Elanor Starmer,
price for the 2015–16 crop year was
approximately $78.00 per marketing agreements and orders may Administrator, Agricultural Marketing
be viewed at: https:// Service.
hundredweight of dates. Utilizing that
price, the estimated crop size, and the www.ams.usda.gov/rules-regulations/ [FR Doc. 2016–22745 Filed 9–20–16; 8:45 am]
assessment rate of $0.05 per moa/small-businesses. Any questions BILLING CODE 3410–02–P
hundredweight, the estimated about the compliance guide should be
assessment revenue for the 2016–17 sent to Richard Lower at the previously
crop year as a percentage of total mentioned address in the FOR FURTHER DEPARTMENT OF HEALTH AND
producer revenue is approximately INFORMATION CONTACT section. HUMAN SERVICES
.00064 percent. After consideration of all relevant
This action decreases the assessment material presented, including the Food and Drug Administration
obligation imposed on handlers. information and recommendation
Assessments are applied uniformly on submitted by the Committee and other 21 CFR Part 878
all handlers, and decreasing the available information, it is hereby found [Docket No. FDA–2016–N–2562]
assessment rate reduces the burden on that this rule, as hereinafter set forth,
handlers, and may reduce the burden on will tend to effectuate the declared Medical Devices; General and Plastic
producers. In addition, the committee policy of the Act. Surgery Devices; Classification of the
meeting was widely publicized Pursuant to 5 U.S.C. 553, it is also Magnetic Surgical Instrument System
throughout the California date industry, found and determined upon good cause
and all interested persons were invited that it is impracticable, unnecessary, AGENCY: Food and Drug Administration,
to attend the meetings and encouraged and contrary to the public interest to HHS.
to participate in committee give preliminary notice prior to putting ACTION: Final order.
deliberations on all issues. Like all this rule into effect, and that good cause
exists for not postponing the effective SUMMARY: The Food and Drug
committee meetings, the June 22, 2016,
date of this rule until 30 days after Administration (FDA) is classifying the
meeting was a public meeting and all
publication in the Federal Register Magnetic Surgical Instrument System
entities, both large and small, were able
because: (1) The 2016–17 crop year into class II (special controls). The
to express views on this issue. Industry
begins on October 1, 2016, and the special controls that will apply to the
members also discussed the various
marketing order requires that the rate of device are identified in this order and
possible assessment rates, potential crop
assessment for each crop year apply to will be part of the codified language for
size, and estimated expenses at this
all assessable dates handled during such the magnetic surgical instrument
meeting. Finally, interested persons are
crop year; (2) the action decreases the system’s classification. The Agency is
invited to submit comments on this
interim rule, including the regulatory assessment rate for assessable dates classifying the device into class II
and informational impacts of this action beginning with the 2016–17 crop year; (special controls) in order to provide a
on small businesses. (3) handlers are aware of this action reasonable assurance of safety and
In accordance with the Paperwork which was unanimously recommended effectiveness of the device.
Reduction Act of 1995 (44 U.S.C. by the committee at a public meeting DATES: This order is effective September
Chapter 35), the order’s information and is similar to other assessment rate 21, 2016. The classification was
collection requirements have been actions issued in past years; and (4) this applicable on June 13, 2016.
previously approved by the Office of interim rule provides a 60-day comment FOR FURTHER INFORMATION CONTACT:
Management and Budget (OMB) and period, and all comments timely Varun Pattani, Center for Devices and
assigned OMB No. 0581–0178, received will be considered prior to Radiological Health, Food and Drug
‘‘Vegetable and Specialty Crop finalization of this rule. Administration, 10903 New Hampshire
Marketing Orders.’’ No changes in those List of Subjects in 7 CFR Part 987 Ave., Bldg. 66, Rm. G452, Silver Spring,
requirements as a result of this action MD, 20993–0002, 301–796–6368,
are necessary. Should any changes Dates, Marketing agreements, varun.pattani@fda.hhs.gov.
become necessary, they would be Reporting and recordkeeping SUPPLEMENTARY INFORMATION:
submitted to OMB for approval. requirements.
This action imposes no additional For the reasons set forth in the I. Background
reporting or recordkeeping requirements preamble, 7 CFR part 987 is amended as In accordance with section 513(f)(1) of
on either small or large Riverside follows: the Federal Food, Drug, and Cosmetic
County, California date handlers. As Act (the FD&C Act) (21 U.S.C.
with all Federal marketing order PART 987—DOMESTIC DATES 360c(f)(1)), devices that were not in
programs, reports and forms are PRODUCED OR PACKED IN commercial distribution before May 28,
periodically reviewed to reduce RIVERSIDE COUNTY, CALIFORNIA 1976 (the date of enactment of the
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information requirements and ■ 1. The authority citation for 7 CFR Medical Device Amendments of 1976),
duplication by industry and public part 987 continues to read as follows: generally referred to as postamendments
sector agencies. devices, are classified automatically by
AMS is committed to complying with Authority: 7 U.S.C. 601–674. statute into class III without any FDA
the E-Government Act, to promote the ■ 2. Section 987.339 is revised to read rulemaking process. These devices
use of the internet and other as follows: remain in class III and require
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FDA believes that the special controls, of Food and Drugs, 21 CFR part 878 is (7) Training must be developed and
in addition to the general controls, amended as follows: validated by human factors testing and
address these risks to health and analysis to ensure users can follow the
provide reasonable assurance of the PART 878—GENERAL AND PLASTIC instructions for use to allow safe use of
safety and effectiveness. SURGERY DEVICES the device.
A magnetic surgical instrument (8) Labeling must include:
■ 1. The authority citation for part 878
system device is not safe for use except (i) Magnetic field safe zones.
continues to read as follows:
under the supervision of a practitioner (ii) Instructions for proper device use.
licensed by law to direct the use of the Authority: 21 U.S.C. 351, 360, 360c, 360e, (iii) A screening checklist to ensure
device. As such, the device is a 360j, 360l, 371. that all patients and operating staff are
prescription device and must satisfy ■ 2. Add § 878.4815 to subpart E to read screened from bringing ferromagnetic
prescription labeling requirements (see as follows: implants, devices, or objects near the
21 CFR 801.109, Prescription devices). external magnet.
§ 878.4815 Magnetic surgical instrument (iv) Reprocessing instructions for any
Section 510(m) of the FD&C Act
system.
provides that FDA may exempt a class reusable components.
II device from the premarket notification (a) Identification. A magnetic surgical (v) Shelf life.
requirements under section 510(k) of the instrument system is a prescription (vi) Use life.
FD&C Act, if FDA determines that device used in laparoscopic surgical
Dated: September 15, 2016.
premarket notification is not necessary procedures consisting of several
components, such as surgical Leslie Kux,
to provide reasonable assurance of the Associate Commissioner for Policy.
safety and effectiveness of the device. instruments, and a magnetic controller.
For this type of device, FDA has The magnetic controller is provided [FR Doc. 2016–22709 Filed 9–20–16; 8:45 am]
determined that premarket notification separately from the surgical instrument BILLING CODE 4164–01–P
is necessary to provide reasonable and is used outside the patient. The
assurance of the safety and effectiveness external magnetic controller is
of the device. Therefore, this device magnetically coupled with the internal DEPARTMENT OF HOUSING AND
type is not exempt from premarket surgical instrument(s) at the surgical site URBAN DEVELOPMENT
notification requirements. Persons who to grasp, hold, retract, mobilize, or
intend to market this type of device manipulate soft tissue and organs. 24 CFR Part 5
must submit to FDA a premarket (b) Classification. Class II (special
controls). The special controls for this [Docket No. FR 5863–F–02]
notification, prior to marketing the
device, which contains information device are: RIN 2506–AC40
(1) In vivo performance data must
about the magnetic surgical instrument
demonstrate that the device performs as Equal Access in Accordance With an
system they intend to market.
intended under anticipated conditions Individual’s Gender Identity in
II. Environmental Impact of use. Testing must demonstrate the Community Planning and Development
ability of the device to grasp, hold, Programs
The Agency has determined under 21
retract, mobilize, or manipulate soft
CFR 25.34(b) that this action is of a type AGENCY: Office of the Secretary, HUD.
tissue and organs.
that does not individually or ACTION: Final rule.
(2) Non-clinical performance data
cumulatively have a significant effect on
must demonstrate that the system
the human environment. Therefore, SUMMARY: Through this final rule, HUD
performs as intended under anticipated
neither an environmental assessment ensures equal access for individuals in
conditions of use. The following
nor an environmental impact statement accordance with their gender identity in
performance characteristics must be
is required. programs and shelter funded under
tested:
III. Paperwork Reduction Act of 1995 (i) Magnetic field strength testing programs administered by HUD’s Office
characterization to identify the of Community Planning and
This final order establishes special Development (CPD). This rule builds
distances from the magnet that are safe
controls that refer to previously upon HUD’s February 2012 final rule
for patients and users with
approved collections of information entitled ‘‘Equal Access to Housing in
ferromagnetic implants, devices, or
found in other FDA regulations. These HUD Programs Regardless of Sexual
objects.
collections of information are subject to (ii) Ability of the internal surgical Orientation or Gender Identity’’ (2012
review by the Office of Management and instrument(s) to be coupled, de-coupled, Equal Access Rule), which aimed to
Budget (OMB) under the Paperwork and re-coupled with the external magnet ensure that HUD’s housing programs
Reduction Act of 1995 (44 U.S.C. 3501– over the external magnet use life. would be open to all eligible individuals
3520). The collections of information in (3) The patient-contacting and families regardless of sexual
part 807, subpart E, regarding premarket components of the device must be orientation, gender identity, or marital
notification submissions have been demonstrated to be biocompatible. status. The 2012 Equal Access Rule,
approved under OMB control number (4) Performance data must however, did not address how
0910–0120, and the collections of demonstrate the sterility of the device transgender and gender non-conforming
information in 21 CFR part 801, components that are patient-contacting. individuals should be accommodated in
regarding labeling have been approved (5) Methods and instructions for temporary, emergency shelters, and
under OMB control number 0910–0485. reprocessing reusable components must other buildings and facilities used for
Lhorne on DSK30JT082PROD with RULES
List of Subjects in 21 CFR Part 878 be validated. shelter, that have physical limitations or
(6) Performance data must support configurations that require and that are
Medical devices. shelf life by demonstrating continued permitted to have shared sleeping
Therefore, under the Federal Food, sterility of the device or the sterile quarters or shared bathing facilities.
Drug, and Cosmetic Act and under components and device functionality This final rule follows HUD’s November
authority delegated to the Commissioner over the labeled shelf life. 2015 proposed rule, which addressed
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Document Created: 2016-09-21 01:31:29
Document Modified: 2016-09-21 01:31:29
| 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 21, 2016. The classification was applicable on June 13, 2016. | |
| Contact | Varun Pattani, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G452, Silver Spring, MD, 20993-0002, 301-796-6368, [email protected] | |
| FR Citation | 81 FR 64761 |
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