83 FR 9698 - Medical Devices; General and Plastic Surgery Devices; Classification of the Extracorporeal Shock Wave Device for Treatment of Chronic Wounds
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 45 (March 7, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 45 (March 7, 2018)
| Page Range | 9698-9700 | |
| FR Document | 2018-04616 |
[Federal Register Volume 83, Number 45 (Wednesday, March 7, 2018)] [Rules and Regulations] [Pages 9698-9700] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04616] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2018-N-0387] Medical Devices; General and Plastic Surgery Devices; Classification of the Extracorporeal Shock Wave Device for Treatment of Chronic Wounds AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the extracorporeal shock wave device for treatment of chronic wounds 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 extracorporeal shock wave device for treatment of chronic wounds' 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 March 7, 2018. The classification was applicable on December 28, 2017. FOR FURTHER INFORMATION CONTACT: Mehmet Kosoglu, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1572, Silver Spring, MD 20993-0002, 301-796-6194, Mehmet.Kosoglu@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the extracorporeal shock wave device for treatment of chronic wounds 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 to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). 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 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 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 July 25, 2016, Sanuwave, Inc., submitted a request for De Novo classification of the dermaPACE 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 [[Page 9699]] 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 28, 2017, 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 878.4685. We have named the generic type of device extracorporeal shock wave device for treatment of chronic wounds, and it is identified as a prescription device that focuses acoustic shock waves onto the dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface. 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--Extracorporeal Shock Wave Device for Treatment of Chronic Wounds Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Adverse tissue reaction................ Biocompatibility evaluation. Infection.............................. Reprocessing validation and Labeling. Inadequate healing..................... Labeling. Device failure/malfunction leading to Non-clinical performance application site injury. testing; Electrical safety testing; Electromagnetic compatibility (EMC) testing; Use life testing; Software verification, validation, and hazard analysis; and Labeling. Hearing loss........................... Non-clinical performance testing 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). At the time of classification, extracorporeal shock wave devices for treatment of chronic wounds 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 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 and guidance. 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 part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910- 0485. List of Subjects in 21 CFR Part 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. 878.4685 to subpart E to read as follows: Sec. 878.4685 Extracorporeal shock wave device for treatment of chronic wounds. (a) Identification. An extracorporeal shock wave device for treatment of chronic wounds is a prescription device that focuses acoustic shock waves onto the dermal tissue. The shock waves are generated inside the device and transferred to the body using an acoustic interface. (b) Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical performance testing must be conducted to demonstrate that the system produces anticipated and reproducible acoustic pressure shock waves. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance data must demonstrate that the reusable components of the device can be reprocessed for subsequent use. (4) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety of the device. (5) Software verification, validation, and hazard analysis must be performed. (6) Performance data must support the use life of the system by demonstrating continued system functionality over the labeled use life. (7) Physician labeling must include: (i) Information on how the device operates and the typical course of treatment; (ii) A detailed summary of the device's technical parameters; (iii) Validated methods and instructions for reprocessing of any reusable components; and (iv) Instructions for preventing hearing loss by use of hearing protection. (8) Patient labeling must include: (i) Relevant contraindications, warnings, precautions, adverse effects, and complications; (ii) Information on how the device operates and the typical course of treatment; [[Page 9700]] (iii) The probable risks and benefits associated with the use of the device; (iv) Post-procedure care instructions; and (v) Alternative treatments. Dated: February 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-04616 Filed 3-6-18; 8:45 am] BILLING CODE 4164-01-P
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TABLE II TO PART 157—Continued FOR FURTHER INFORMATION CONTACT: may utilize either procedure for De
Mehmet Kosoglu, Center for Devices Novo classification.
Year Limit and Radiological Health, Food and Drug Under the first procedure, the person
Administration, 10903 New Hampshire submits a 510(k) for a device that has
1997 ...................................... 4,400,000 Ave., Bldg. 66, Rm. 1572, Silver Spring, not previously been classified. After
1998 ...................................... 4,500,000 MD 20993–0002, 301–796–6194, receiving an order from FDA classifying
1999 ...................................... 4,550,000 the device into class III under section
2000 ...................................... 4,650,000
Mehmet.Kosoglu@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 513(f)(1) of the FD&C Act, the person
2001 ...................................... 4,750,000
2002 ...................................... 4,850,000 then requests a classification under
2003 ...................................... 4,900,000 I. Background section 513(f)(2).
2004 ...................................... 5,000,000 Upon request, FDA has classified the Under the second procedure, rather
2005 ...................................... 5,100,000 extracorporeal shock wave device for than first submitting a 510(k) and then
2006 ...................................... 5,250,000 treatment of chronic wounds as class II a request for classification, if the person
2007 ...................................... 5,400,000
(special controls), which we have determines that there is no legally
2008 ...................................... 5,550,000
determined will provide a reasonable marketed device upon which to base a
2009 ...................................... 5,600,000 determination of substantial
2010 ...................................... 5,700,000 assurance of safety and effectiveness. In
addition, we believe this action will equivalence, that person requests a
2011 ...................................... 5,750,000 classification under section 513(f)(2) of
2012 ...................................... 5,850,000 enhance patients’ access to beneficial
the FD&C Act.
2013 ...................................... 6,000,000 innovation, in part by reducing
2014 ...................................... 6,100,000
Under either procedure for De Novo
regulatory burdens by placing the classification, FDA shall classify the
2015 ...................................... 6,200,000 device into a lower device class than the
2016 ...................................... 6,300,000 device by written order within 120 days.
automatic class III assignment. The classification will be according to
2017 ...................................... 6,400,000
The automatic assignment of class III the criteria under section 513(a)(1) of
2018 ...................................... 6,500,000
occurs by operation of law and without the FD&C Act. Although the device was
* * * * * any action by FDA, regardless of the automatically within class III, the De
[FR Doc. 2018–04413 Filed 3–6–18; 8:45 am] level of risk posed by the new device. Novo classification is considered to be
BILLING CODE 6717–01–P
Any device that was not in commercial the initial classification of the device.
distribution before May 28, 1976, is We believe this De Novo classification
automatically classified as, and remains will enhance patients’ access to
within, class III and requires premarket beneficial innovation, in part by
DEPARTMENT OF HEALTH AND
approval unless and until FDA takes an reducing regulatory burdens. When FDA
HUMAN SERVICES
action to classify or reclassify the device classifies a device into class I or II via
Food and Drug Administration (see 21 U.S.C. 360c(f)(1)). We refer to the De Novo process, the device can
these devices as ‘‘postamendments serve as a predicate for future devices of
21 CFR Part 878 devices’’ because they were not in that type, including for 510(k)s (see 21
commercial distribution prior to the U.S.C. 360c(f)(2)(B)(i)). As a result, other
[Docket No. FDA–2018–N–0387] date of enactment of the Medical Device device sponsors do not have to submit
Amendments of 1976, which amended a De Novo request or premarket
Medical Devices; General and Plastic the Federal Food, Drug, and Cosmetic
Surgery Devices; Classification of the approval application in order to market
Act (FD&C Act). a substantially equivalent device (see 21
Extracorporeal Shock Wave Device for
FDA may take a variety of actions in U.S.C. 360c(i), defining ‘‘substantial
Treatment of Chronic Wounds
appropriate circumstances to classify or equivalence’’). Instead, sponsors can use
AGENCY: Food and Drug Administration, reclassify a device into class I or II. We the less-burdensome 510(k) process,
HHS. may issue an order finding a new device when necessary, to market their device.
ACTION: Final order. to be substantially equivalent under
section 513(i) of the FD&C Act to a II. De Novo Classification
SUMMARY: The Food and Drug predicate device that does not require On July 25, 2016, Sanuwave, Inc.,
Administration (FDA or we) is premarket approval (see 21 U.S.C. submitted a request for De Novo
classifying the extracorporeal shock 360c(i)). We determine whether a new classification of the dermaPACE System.
wave device for treatment of chronic device is substantially equivalent to a FDA reviewed the request in order to
wounds into class II (special controls). predicate by means of the procedures classify the device under the criteria for
The special controls that apply to the for premarket notification under section classification set forth in section
device type are identified in this order 510(k) of the FD&C Act and part 807 (21 513(a)(1) of the FD&C Act.
and will be part of the codified language U.S.C. 360(k) and 21 CFR part 807, We classify devices into class II if
for the extracorporeal shock wave respectively). general controls by themselves are
device for treatment of chronic wounds’ FDA may also classify a device insufficient to provide reasonable
classification. We are taking this action through ‘‘De Novo’’ classification, a assurance of safety and effectiveness,
because we have determined that common name for the process but there is sufficient information to
classifying the device into class II authorized under section 513(f)(2) of the establish special controls that, in
(special controls) will provide a FD&C Act. Section 207 of the Food and combination with the general controls,
reasonable assurance of safety and Drug Administration Modernization Act provide reasonable assurance of the
effectiveness of the device. We believe of 1997 established the first procedure safety and effectiveness of the device for
daltland on DSKBBV9HB2PROD with RULES
this action will also enhance patients’ for De Novo classification (Pub. L. 105– its intended use (see 21 U.S.C.
access to beneficial innovative devices, 115). Section 607 of the Food and Drug 360c(a)(1)(B)). After review of the
in part by reducing regulatory burdens. Administration Safety and Innovation information submitted in the request,
DATES: This order is effective March 7, Act modified the De Novo application we determined that the device can be
2018. The classification was applicable process by adding a second procedure classified into class II with the
on December 28, 2017. (Pub. L. 112–144). A device sponsor establishment of special controls. FDA
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(iii) The probable risks and benefits Register (79 FR 67396) on the same day. 2014, and expired on or before
associated with the use of the device; The text of the temporary regulation November 10, 2017. This document
(iv) Post-procedure care instructions; served as the text of the proposed adopts, without modification, the
and regulation. proposed regulation as final and
(v) Alternative treatments. removes the corresponding temporary
Summary of Comments and
Dated: February 28, 2018. Explanation of Revisions regulation.
Leslie Kux, The IRS provided an opportunity for Special Analyses
Associate Commissioner for Policy. comment and an opportunity for a Certain IRS regulations, including this
[FR Doc. 2018–04616 Filed 3–6–18; 8:45 am] public hearing. No public hearing was one, are exempt from the requirements
BILLING CODE 4164–01–P requested, and the IRS received one of Executive Order 12866, as
written comment. The written comment supplemented and reaffirmed by
did not substantively address the Executive Order 13563. Therefore, a
DEPARTMENT OF THE TREASURY proposed change, but instead expressed regulatory impact assessment is not
appreciation for the IRS’s efforts to required. Because the regulation would
Internal Revenue Service obtain public feedback to support an not impose a collection of information
open, measurable, and user-friendly on small entities, the Regulatory
26 CFR Part 801 government. Flexibility Act (5 U.S.C. chapter 6) does
[TD 9831]
The regulation being modified not apply.
concerns ‘‘employee satisfaction Pursuant to Section 7805(f) of the
RIN 1545–BL88 measures’’ and requires the collection of Internal Revenue Code, the notice of
information from employees through proposed rulemaking preceding this
Balanced System for Measuring various means, including employee final regulation was submitted to the
Organizational and Employee surveys. Once collected, the information Chief Counsel for Advocacy of the Small
Performance Within the Internal is used to measure and report on Business Administration for comment
Revenue Service employee satisfaction, one of three on its impact on small business. No
AGENCY: Internal Revenue Service (IRS), elements comprising the IRS balanced comments were received from the Small
Treasury. performance measurement system. To Business Administration.
be consistent with other government-
ACTION: Final regulations and removal of Drafting Information
wide employee satisfaction surveys, the
temporary regulations. proposed regulation provides that The principal author of these
SUMMARY: This document contains final employee satisfaction measures can be regulations is Julie A. Barry, Office of
regulations regarding management and reported at a higher agency level. Associate Chief Counsel (General Legal
personnel within the IRS. The final Specifically, the proposed regulation Services). However, other personnel
regulations relate to the ‘‘employee relates to the employee satisfaction from the Treasury Department and the
satisfaction measures’’ utilized by the measure, § 801.5, of the IRS Balanced IRS participated in their development.
IRS in its Balanced System for System for Measuring Organizational
and Employee Performance (26 CFR part List of Subjects in 26 CFR Part 801
Measuring Organizational and
Employee Performance. These 801). As originally implemented in Federal employees, Organization and
regulations affect internal operations of 1999, the employee satisfaction measure functions (Government agencies).
required the IRS to gauge and report the
the IRS and the systems employed to Adoption of Amendments to the
satisfaction of employees in pay and
evaluate the performance of Regulations
duty status (non-seasonal employees) to
organizations within the IRS and
the first-level supervisor organizational Accordingly, 26 CFR part 801 is
individuals employed by the IRS.
level, as well as to all succeeding amended as follows:
DATES: management levels of the organization.
Effective Date: These regulations are Consequently, the IRS utilized and PART 801—BALANCED SYSTEM FOR
effective on March 7, 2018. modified a pre-existing survey to enable MEASURING ORGANIZATIONAL AND
Applicability Date: These regulations the reporting of data to first-level EMPLOYEE PERFORMANCE WITHIN
are applicable for the reporting of supervisors. Other surveys, such as THE INTERNAL REVENUE SERVICE
employee satisfaction information OPM’s Federal Employee Viewpoint
within the meaning of 26 CFR 801.5 that ■ Paragraph 1. The authority citation
Survey (FEVS), however, report
occurs on or after March 7, 2018. for part 801 continues to read in part as
employee satisfaction data to a level of
FOR FURTHER INFORMATION CONTACT: Julie follows:
agency management higher than that of
Barry, at (202) 317–5759 (not a toll free the first-level supervisor. Consequently, Authority: 5 U.S.C. 9501 * * *
number). the IRS conducted both the FEVS survey ■ Par. 2. Section 801.5 is revised to read
SUPPLEMENTARY INFORMATION: and the internal survey that complied as follows:
with § 801.5. The administration of both
Background § 801.5 Employee satisfaction measures.
surveys resulted in an unnecessary
On November 13, 2014, the IRS expenditure of funds, an undue burden (a) The employee satisfaction
published in the Federal Register (79 on employees, and the duplication of numerical ratings to be given to a
FR 67351) a temporary regulation (TD efforts by the IRS. Business Operating Division (BOD) or
9703) modifying the regulations The proposed regulation permits the equivalent office within the IRS will be
daltland on DSKBBV9HB2PROD with RULES
governing the IRS Balanced System for IRS to report employee satisfaction data determined on the basis of information
Measuring Organizational and at higher organization levels, thereby gathered through various methods. For
Employee Performance. A notice of permitting the IRS to use the FEVS and example, questionnaires, surveys, and
proposed rulemaking (REG–138605–13) eliminate the use of its internal survey. other information gathering mechanisms
cross-referencing the temporary The corresponding temporary regulation may be employed to gather data
regulation was published in the Federal was effective on or after November 13, regarding satisfaction. The information
VerDate Sep<11>2014 16:31 Mar 06, 2018 Jkt 244001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\07MRR1.SGM 07MRR1](https://thefederalregister.org/doc/83_FR_9743/page/3.svg)
Document Created: 2018-03-07 01:27:32
Document Modified: 2018-03-07 01:27:32
| 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 March 7, 2018. The classification was applicable on December 28, 2017. | |
| Contact | Mehmet Kosoglu, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1572, Silver Spring, MD 20993-0002, 301-796-6194, [email protected] | |
| FR Citation | 83 FR 9698 |
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