83 FR 54007 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Active Implantable Bone Conduction Hearing System
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 208 (October 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 208 (October 26, 2018)
| Page Range | 54007-54010 | |
| FR Document | 2018-23412 |
[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)] [Rules and Regulations] [Pages 54007-54010] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23412] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 874 [Docket No. FDA-2018-N-3772] Medical Devices; Ear, Nose, and Throat Devices; Classification of the Active Implantable Bone Conduction Hearing System AGENCY: Food and Drug Administration, HHS. [[Page 54008]] ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is classifying the active implantable bone conduction hearing system 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 active implantable bone conduction hearing system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. DATES: This order is effective October 26, 2018. The classification was applicable on July 20, 2018. FOR FURTHER INFORMATION CONTACT: Oldooz Hazrati, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2455, Silver Spring, MD 20993-0002, 240-402-9903, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Upon request, FDA has classified the active implantable bone conduction hearing system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment. The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as ``postamendments devices'' because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807). FDA may also classify a device through ``De Novo'' classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. 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 is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device. We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application 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 February 16, 2017, MED-EL Elektromedizinische Geraete GmbH submitted a request for De Novo classification of the BONEBRIDGE. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on July 20, 2018, 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 874.3340. We have named the generic type of device active implantable bone conduction hearing system, and it is identified as a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone. 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. [[Page 54009]] Table 1--Active Implantable Bone Conduction Hearing System Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks Mitigation measures ------------------------------------------------------------------------ Dural erosion or compression resulting Labeling. from failure to confirm adequate thickness and consistency of bone and related anatomy. Surgical complications leading to:Bleeding/hematoma......... Seizures.................. Cerebrospinal fluid (CSF) leak. Implant damage or Clinical performance testing migration leading to revision/ and Labeling. explantation. Device software failure................ Software verification, validation, and hazard analysis. Implant failure due to: Fatigue.................. Damage/breakage.......... Loss of hermeticity....... Clinical performance testing and Non-clinical performance testing. Device failure to compensate for Clinical performance testing hearing loss. and Non-clinical performance testing. Interference with other devices........ Electromagnetic compatibility testing, Wireless coexistence testing, Electrical safety testing, and Labeling. Adverse tissue reaction................ Biocompatibility evaluation and Labeling. Infection.............................. Sterilization validation, Shelf life 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) of the FD&C Act. At the time of classification, active implantable bone conduction hearing systems are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)). III. Analysis of Environmental Impact We have 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 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910- 0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; 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 874 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 874 is amended as follows: PART 874--EAR, NOSE, AND THROAT DEVICES 0 1. The authority citation for part 874 is revised to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 874.3340 to subpart D to read as follows: Sec. 874.3340 Active implantable bone conduction hearing system. (a) Identification. An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must characterize any adverse events observed during implantation and clinical use, and must also demonstrate that the device performs as intended under anticipated conditions of use. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Performance data must validate force output in a clinically relevant model. (ii) Impact testing in a clinically relevant anatomic model must be performed. (iii) Mechanical integrity testing must be performed. (iv) Reliability testing consistent with expected device life must be performed. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of the patient- contacting components of the device. (5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (6) Performance data must demonstrate the wireless compatibility, electromagnetic compatibility, and electrical safety of the device. (7) Software verification, validation, and hazard analysis must be performed. [[Page 54010]] (8) Labeling must include: (i) A summary of clinical testing conducted with the device that includes a summary of device-related complications and adverse events; (ii) Instructions for use; (iii) A surgical guide for implantation, which includes instructions for imaging to assess bone dimensions; (iv) A shelf life, for device components provided sterile; (v) A patient identification card; and (vi) A patient user manual. Dated: October 22, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-23412 Filed 10-25-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Rules and Regulations 54007
TABLE 1—HIGH FLOW HUMIDIFIED OXYGEN DELIVERY DEVICE RISKS AND MITIGATION MEASURES
Identified risks Mitigation measures
Adverse tissue reaction ............................................................................ Biocompatibility evaluation, Non-clinical performance testing, and La-
beling.
Interference with other devices ................................................................ Electromagnetic compatibility testing, Radiofrequency identification test-
ing, and Labeling.
Infection .................................................................................................... Cleaning validation and Labeling.
Device software failure leading to delayed initiation of therapy .............. Software verification, validation, and hazard analysis; and Labeling.
Device failure/malfunction leading to ineffective treatment ...................... Non-clinical performance testing and Labeling.
Electrical shock injury from device failure ................................................ Electrical safety, thermal safety, and mechanical safety testing.
Use error/improper device use leading to hypoxia or worsening Labeling.
hypercarbia.
FDA has determined that special number 0910–0073; the collections of (ii) Continuous use thermal stability
controls, in combination with the information in 21 CFR part 814, testing must be performed;
general controls, address these risks to subparts A through E, regarding (iii) Humidity output testing must be
health and provide reasonable assurance premarket approval, have been performed; and
of safety and effectiveness. For a device approved under OMB control number (iv) Blender performance testing must
to fall within this classification, and 0910–0231; the collections of evaluate fraction of inspired oxygen
thus avoid automatic classification in information in part 807, subpart E, (FiO2) blending accuracy.
class III, it would have to comply with regarding premarket notification (3) Performance data must validate
the special controls named in this final submissions, have been approved under cleaning instructions for any reusable
order. The necessary special controls OMB control number 0910–0120; and components of the device.
appear in the regulation codified by this the collections of information in 21 CFR (4) Electrical safety, thermal safety,
order. This device is subject to part 801, regarding labeling, have been mechanical safety, electromagnetic
premarket notification requirements approved under OMB control number compatibility, and radiofrequency
under section 510(k) of the FD&C Act. 0910–0485. identification testing must be
At the time of classification, high flow performed.
humidified oxygen delivery devices are List of Subjects in 21 CFR Part 868 (5) Software verification, validation,
for prescription use only. Prescription Medical devices. and hazard analysis must be performed.
devices are exempt from the (6) Labeling must include:
Therefore, under the Federal Food, (i) A description of available FiO2
requirement for adequate directions for Drug, and Cosmetic Act and under
use for the layperson under section ranges for different flowrates and inlet
authority delegated to the Commissioner gas pressures;
502(f)(1) of the FD&C Act (21 U.S.C. of Food and Drugs, 21 CFR part 868 is
352(f)(1)) and 21 CFR 801.5, as long as (ii) Instructions for applicable
amended as follows: flowrates for all intended populations;
the conditions of 21 CFR 801.109 are
met (referring to 21 U.S.C. 352(f)(1)). (iii) A warning that patients on high
PART 868—ANESTHESIOLOGY flow oxygen are acute and require
III. Analysis of Environmental Impact DEVICES appropriate monitoring, to include
We have determined under 21 CFR pulse oximetry;
■ 1. The authority citation for part 868
25.34(b) that this action is of a type that (iv) A warning regarding the risk of
continues to read as follows:
does not individually or cumulatively condensation at low set temperatures
Authority: 21 U.S.C. 351, 360, 360c, 360e, and certain flows; and
have a significant effect on the human
360j, 360l, 371. (v) A description of all alarms and
environment. Therefore, neither an
environmental assessment nor an ■ 2. Add § 868.5454 to subpart F to read their functions.
environmental impact statement is as follows: Dated: October 22, 2018.
required. Leslie Kux,
§ 868.5454 High flow humidified oxygen
IV. Paperwork Reduction Act of 1995 delivery device. Associate Commissioner for Policy.
[FR Doc. 2018–23409 Filed 10–25–18; 8:45 am]
This final order establishes special (a) Identification. A high flow
BILLING CODE 4164–01–P
controls that refer to previously humidified oxygen delivery device is a
approved collections of information prescription device that delivers high
found in other FDA regulations and flow oxygen with humidification for
DEPARTMENT OF HEALTH AND
guidance. These collections of patients who are suffering from
HUMAN SERVICES
information are subject to review by the respiratory distress and/or hypoxemia.
Office of Management and Budget (b) Classification. Class II (special Food and Drug Administration
(OMB) under the Paperwork Reduction controls). The special controls for this
Act of 1995 (44 U.S.C. 3501–3520). The device are: 21 CFR Part 874
collections of information in the (1) The patient-contacting
guidance document ‘‘De Novo components of the device must be [Docket No. FDA–2018–N–3772]
khammond on DSK30JT082PROD with RULES
Classification Process (Evaluation of demonstrated to be biocompatible.
Medical Devices; Ear, Nose, and Throat
Automatic Class III Designation)’’ have (2) Non-clinical performance testing
Devices; Classification of the Active
been approved under OMB control must demonstrate that the device
Implantable Bone Conduction Hearing
number 0910–0844; the collections of performs as intended under anticipated
System
information in 21 CFR part 820, conditions for use, including the
regarding quality system regulation, following: AGENCY: Food and Drug Administration,
have been approved under OMB control (i) Alarm testing must be performed; HHS.
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![54010 Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Rules and Regulations
(8) Labeling must include: section 1201(a)(1) of title 17, United technological measure that ‘‘effectively
(i) A summary of clinical testing States Code, has determined in this controls access to a work’’ is one that
conducted with the device that includes seventh triennial rulemaking proceeding ‘‘in the ordinary course of its operation,
a summary of device-related that the prohibition against requires the application of information,
complications and adverse events; circumvention of technological or a process or a treatment, with the
(ii) Instructions for use; measures that effectively control access authority of the copyright owner, to gain
(iii) A surgical guide for implantation, to copyrighted works shall not apply to access to the work.’’ 4
which includes instructions for imaging persons who engage in noninfringing Section 1201(a)(1) also includes what
to assess bone dimensions; uses of certain classes of such works. Congress characterized as a ‘‘fail-safe’’
(iv) A shelf life, for device This determination is based upon the mechanism,5 which requires the
components provided sterile; Recommendation of the Acting Register Librarian of Congress, following a
(v) A patient identification card; and of Copyrights, which was transmitted to rulemaking proceeding, to publish any
(vi) A patient user manual. the Librarian on October 5, 2018.1 class of copyrighted works as to which
The below discussion summarizes the the Librarian has determined that
Dated: October 22, 2018.
rulemaking proceeding and Register’s noninfringing uses by persons who are
Leslie Kux,
Recommendation, announces the users of a copyrighted work are, or are
Associate Commissioner for Policy. Librarian’s determination, and likely to be, adversely affected by the
[FR Doc. 2018–23412 Filed 10–25–18; 8:45 am] publishes the regulatory text specifying prohibition against circumvention in the
BILLING CODE 4164–01–P the exempted classes of works. A more succeeding three-year period, thereby
complete discussion of the rulemaking exempting that class from the
process, the evidentiary record, and the prohibition for that period.6 The
LIBRARY OF CONGRESS Acting Register’s analysis can be found Librarian’s determination to grant an
in the Acting Register’s exemption is based upon the
U.S. Copyright Office Recommendation, which is posted at recommendation of the Register of
www.copyright.gov/1201/2018/. Copyrights, who conducts the
37 CFR Part 201 rulemaking proceeding.7 The Register,
I. Background
[Docket No. 2017–10] in turn, consults with the Assistant
A. Statutory Requirements Secretary for Communications and
Exemption to Prohibition on Congress enacted the DMCA in 1998 Information of the Department of
Circumvention of Copyright Protection to implement certain provisions of the Commerce, who oversees the National
Systems for Access Control WIPO Copyright and WIPO Telecommunications and Information
Technologies Performances and Phonograms Treaties. Administration (‘‘NTIA’’), in the course
Among other things, title I of the DMCA, of formulating her recommendation.8
AGENCY: U.S. Copyright Office, Library The primary responsibility of the
of Congress. which added a new chapter 12 to title
17 of the U.S. Code, prohibits Register and the Librarian in the
ACTION: Final rule. rulemaking proceeding is to assess
circumvention of technological
measures employed by or on behalf of whether the implementation of access
SUMMARY: In this final rule, the Librarian
copyright owners to protect access to controls impairs the ability of
of Congress adopts exemptions to the
their works. In enacting this aspect of individuals to make noninfringing uses
provision of the Digital Millennium
the law, Congress observed that of copyrighted works within the
Copyright Act (‘‘DMCA’’) that prohibits
technological protection measures meaning of section 1201(a)(1). To do
circumvention of technological
(‘‘TPMs’’) can ‘‘support new ways of this, the Register develops a
measures that control access to
disseminating copyrighted materials to comprehensive administrative record
copyrighted works, codified in the
users, and . . . safeguard the using information submitted by
United States Code. As required under
availability of legitimate uses of those interested members of the public, and
the statute, the Acting Register of
materials by individuals.’’ 2 makes recommendations to the
Copyrights, following a public
Section 1201(a)(1) provides in Librarian concerning whether
proceeding, submitted a
pertinent part that ‘‘[n]o person shall exemptions are warranted based on that
Recommendation concerning proposed
circumvent a technological measure that record.
exemptions to the Librarian of Congress.
effectively controls access to a work Under the statutory framework, the
After careful consideration, the
protected under [title 17].’’ Under the Librarian, and thus the Register, must
Librarian adopts final regulations based
statute, to ‘‘circumvent a technological consider ‘‘(i) the availability for use of
upon the Acting Register’s
measure’’ means ‘‘to descramble a copyrighted works; (ii) the availability
Recommendation.
scrambled work, to decrypt an for use of works for nonprofit archival,
DATE: Effective October 28, 2018. encrypted work, or otherwise to avoid, preservation, and educational purposes;
FOR FURTHER INFORMATION CONTACT: bypass, remove, deactivate, or impair a (iii) the impact that the prohibition on
Regan A. Smith, General Counsel and technological measure, without the the circumvention of technological
Associate Register of Copyrights, by authority of the copyright owner.’’ 3 A measures applied to copyrighted works
email at regans@copyright.gov, Anna has on criticism, comment, news
Chauvet, Assistant General Counsel, by 1 Acting Register of Copyrights, Section 1201 reporting, teaching, scholarship, or
email at achau@copyright.gov, or Kevin Rulemaking: Seventh Triennial Proceeding to research; (iv) the effect of circumvention
Determine Exemptions to the Prohibition on
khammond on DSK30JT082PROD with RULES
Amer, Senior Counsel for Policy and of technological measures on the market
Circumvention, Recommendation of the Acting
International Affairs, by email at Register of Copyrights (Oct. 2018) (‘‘Acting
4 Id. at 1201(a)(3)(B).
kamer@copyright.gov. Each can be Register’s Recommendation’’).
5 See H.R. Rep. No. 105–551, pt. 2, at 36 (1998)
contacted by telephone by calling (202) 2 Staff of H. Comm. on the Judiciary, 105th Cong.,
Section-by-Section Analysis of H.R. 2281 as Passed (‘‘Commerce Comm. Report’’).
707–8350. 6 See 17 U.S.C. 1201(a)(1).
by the United States House of Representatives on
SUPPLEMENTARY INFORMATION: The August 4, 1998, at 7 (Comm. Print 1998). 7 Id. at 1201(a)(1)(C).
Librarian of Congress, pursuant to 3 17 U.S.C. 1201(a)(3)(A). 8 Id.
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Document Created: 2018-10-26 02:29:41
Document Modified: 2018-10-26 02:29:41
| 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 October 26, 2018. The classification was applicable on July 20, 2018. | |
| Contact | Oldooz Hazrati, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2455, Silver Spring, MD 20993-0002, 240-402-9903, [email protected] | |
| FR Citation | 83 FR 54007 |
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