80 FR 57090 - Medical Devices; Ophthalmic Devices; Classification of the Oral Electronic Vision Aid
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 183 (September 22, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 183 (September 22, 2015)
| Page Range | 57090-57092 | |
| FR Document | 2015-24026 |
[Federal Register Volume 80, Number 183 (Tuesday, September 22, 2015)] [Rules and Regulations] [Pages 57090-57092] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24026] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 886 [Docket No. FDA-2015-N-3044] Medical Devices; Ophthalmic Devices; Classification of the Oral Electronic Vision Aid AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the oral electronic vision aid 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 oral electronic vision aid'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 22, 2015. The classification was applicable on June 18, 2015. FOR FURTHER INFORMATION CONTACT: Dexiu Shi, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2246, Silver Spring, MD, 20993-0002, 301-796-6470, dexiu.shi@fda.hhs.gov. 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), 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 (21 U.S.C. 360c(f)(2)), 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). 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), 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) 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 August 7, 2013, Wicab Inc., submitted a request for classification of the BrainPort V100 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 [[Page 57091]] 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 18, 2015, 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 886.5905. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for an oral electronic vision aid will need to comply with the special controls named in this final order. The device is assigned the generic name oral electronic vision aid, and it is identified as a battery-powered prescription device that contains an electrode stimulation array to generate electrotactile stimulation patterns that are derived from digital object images captured by a camera. It is intended to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as a white cane or a guide dog. 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--Oral Electronic Vision Aid Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation method ------------------------------------------------------------------------ Irritation, Discomfort or Adverse Clinical Testing. Events Involving the Mouth, Tongue, or Labeling. Gums. Adverse Tissue Reaction................ Biocompatibility Testing. Labeling. Unit (Hardware) Malfunction, Functional Non-Clinical Performance Reliability. Testing. Clinical Testing. Labeling. Software Malfunction................... Software Verification, Validation, and Hazard Analysis. Use Error.............................. Clinical Testing. Healthcare Professional Training. Patient Training. Labeling. Interference with Other Devices........ Electromagnetic Compatibility and Electromagnetic Interference Testing. Wireless Coexistence Testing. Labeling. Electrical Shock....................... Electrical Safety Testing. Labeling. ------------------------------------------------------------------------ FDA believes that the following special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness:Clinical performance testing must demonstrate an acceptable adverse event profile, including adverse events involving the mouth, tongue, and gums and demonstrate the effect of the stimulation to provide clinically meaningful outcomes. The clinical performance testing must also investigate the anticipated conditions of use, including potential use error, intended environment of use, and duration of use. Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including simulated moisture ingress, device durability, and battery reliability. Software verification, validation, and hazard analysis must be performed. Analysis/testing must validate electromagnetic compatibility. Analysis/testing must validate electrical safety. Analysis/testing must assess and validate wireless coexistence concerns. Any elements of the device that contact the patient must be demonstrated to be biocompatible. Training must include elements to ensure that the healthcare provider and user can identify the safe environments for device use, use all safety features of the device, and operate the device in the intended environment of use. Labeling for the trainer and user must include a summary of the clinical testing including adverse events encountered under use conditions, summary of study outcomes and endpoints, and information pertinent to use of the device including the conditions under which the device was studied (e.g., level of supervision or assistance, and environment of use). Oral electronic vision aid devices are prescription devices 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) 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 oral electronic vision aid 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. [[Page 57092]] 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. 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. DEN130039: De Novo Request per 513(f)(2) from Wicab Inc., dated August 7, 2013. List of Subjects in 21 CFR Part 886 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 886 is amended as follows: PART 886--OPHTHALMIC DEVICES 0 1. The authority citation for 21 CFR part 886 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 0 2. Add Sec. 886.5905 to subpart F to read as follows: Sec. 886.5905 Oral electronic vision aid. (a) Identification. An oral electronic vision aid is a battery- powered prescription device that contains an electrode stimulation array to generate electrotactile stimulation patterns that are derived from digital object images captured by a camera. It is intended to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as a white cane or a guide dog. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must demonstrate an acceptable adverse event profile, including adverse events involving the mouth, tongue, and gums and demonstrate the effect of the stimulation to provide clinically meaningful outcomes. The clinical performance testing must also investigate the anticipated conditions of use, including potential use error, intended environment of use, and duration of use. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including simulated moisture ingress, device durability, and battery reliability. (3) Software verification, validation, and hazard analysis must be performed. (4) Analysis/testing must validate electromagnetic compatibility. (5) Analysis/testing must validate electrical safety. (6) Analysis/testing must assess and validate wireless coexistence concerns. (7) Any elements of the device that contact the patient must be demonstrated to be biocompatible. (8) Training must include elements to ensure that the healthcare provider and user can identify the safe environments for device use, use all safety features of the device, and operate the device in the intended environment of use. (9) Labeling for the trainer and user must include a summary of the clinical testing including adverse events encountered under use conditions, summary of study outcomes and endpoints, and information pertinent to use of the device including the conditions under which the device was studied (e.g., level of supervision or assistance, and environment of use). Dated: September 16, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-24026 Filed 9-21-15; 8:45 am] BILLING CODE 4164-01-P
![57090 Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Rules and Regulations
(2) Contacting the Manufacturer: For any the availability of this material at NARA, call into class I or II, or FDA issues an order
requirement in this AD to obtain corrective 202–741–6030, or go to: http:// finding the device to be substantially
actions from a manufacturer, the action must www.archives.gov/federal-register/cfr/ibr- equivalent, in accordance with section
be accomplished using a method approved locations.html. 513(i), to a predicate device that does
by the Manager, International Branch, ANM–
116, Transport Airplane Directorate, FAA; or
Issued in Renton, Washington, on not require premarket approval. The
September 11, 2015. Agency determines whether new
EASA; or Airbus’s EASA DOA. If approved
by the DOA, the approval must include the Michael Kaszycki, devices are substantially equivalent to
DOA-authorized signature. Acting Manager, Transport Airplane predicate devices by means of
Directorate, Aircraft Certification Service. premarket notification procedures in
(r) Related Information
[FR Doc. 2015–23541 Filed 9–21–15; 8:45 am] section 510(k) of the FD&C Act (21
(1) Refer to Mandatory Continuing BILLING CODE 4910–13–P U.S.C. 360(k)) and part 807 (21 CFR part
Airworthiness Information (MCAI) EASA 807) of the regulations.
Airworthiness Directive 2014–0137, dated Section 513(f)(2) of the FD&C Act (21
May 28, 2014, for related information. This U.S.C. 360c(f)(2)), as amended by
MCAI may be found in the AD docket on the DEPARTMENT OF HEALTH AND
Internet at http://www.regulations.gov by HUMAN SERVICES section 607 of the Food and Drug
searching for and locating Docket No. FAA– Administration Safety and Innovation
2014–0753. Food and Drug Administration Act (Pub. L. 112–144), provides two
(2) Airbus Service information identified in procedures by which a person may
this AD that is not incorporated by reference 21 CFR Part 886 request FDA to classify a device under
is available at the addresses specified in the criteria set forth in section 513(a)(1).
paragraphs (s)(6) and (s)(8) of this AD. [Docket No. FDA–2015–N–3044] Under the first procedure, the person
(s) Material Incorporated by Reference submits a premarket notification under
Medical Devices; Ophthalmic Devices;
section 510(k) of the FD&C Act for a
(1) The Director of the Federal Register Classification of the Oral Electronic
approved the incorporation by reference
device that has not previously been
Vision Aid
(IBR) of the service information listed in this classified and, within 30 days of
paragraph under 5 U.S.C. 552(a) and 1 CFR AGENCY: Food and Drug Administration, receiving an order classifying the device
part 51. HHS. into class III under section 513(f)(1), the
(2) You must use this service information ACTION: Final order. person requests a classification under
as applicable to do the actions required by section 513(f)(2). Under the second
this AD, unless this AD specifies otherwise. SUMMARY: The Food and Drug procedure, rather than first submitting a
(3) The following service information was Administration (FDA) is classifying the premarket notification under section
approved for IBR on October 27, 2015. 510(k) and then a request for
oral electronic vision aid into class II
(i) Airbus Service Bulletin A320–27–1223,
(special controls). The special controls classification under the first procedure,
dated September 3, 2013.
(ii) UTC Aerospace Systems Service that will apply to the device are the person determines that there is no
Bulletin 31075–27–22, dated July 2, 2013. identified in this order and will be part legally marketed device upon which to
(4) The following service information was of the codified language for the oral base a determination of substantial
approved for IBR on October 21, 2011 (76 FR electronic vision aid’s classification. equivalence and requests a classification
57630, September 16, 2011). The Agency is classifying the device under section 513(f)(2) of the FD&C Act.
(i) Airbus Service Bulletin A320–27A1186, into class II (special controls) in order If the person submits a request to
Revision 07, including Appendices 1, 2, 3, 4, to provide a reasonable assurance of classify the device under this second
5, and 6, dated March 2, 2011. procedure, FDA may decline to
safety and effectiveness of the device.
(ii) Reserved. undertake the classification request if
(5) The following service information was DATES: This order is effective September
22, 2015. The classification was FDA identifies a legally marketed device
approved for IBR on September 22, 2009 (74
FR 41611, August 18, 2009). applicable on June 18, 2015. that could provide a reasonable basis for
(i) Airbus All Operators Telex A320– review of substantial equivalence with
FOR FURTHER INFORMATION CONTACT: the device or if FDA determines that the
27A1186, Revision 04, dated April 3, 2009.
Dexiu Shi, Center for Devices and device submitted is not of ‘‘low-
The document number and issue date of
Airbus AOT A320–27A1186, Revision 04, Radiological Health, Food and Drug moderate risk’’ or that general controls
dated April 3, 2009, are specified only on the Administration, 10903 New Hampshire would be inadequate to control the risks
first page of the AOT. Ave., Bldg. 66, Rm. 2246, Silver Spring, and special controls to mitigate the risks
(ii) Reserved. MD, 20993–0002, 301–796–6470, cannot be developed.
(6) For Airbus service information dexiu.shi@fda.hhs.gov. In response to a request to classify a
identified in this AD, contact Airbus, SUPPLEMENTARY INFORMATION: device under either procedure provided
Airworthiness Office—EIAS, 1 Rond Point
Maurice Bellonte, 31707 Blagnac Cedex, I. Background by section 513(f)(2) of the FD&C Act,
France; telephone +33 5 61 93 36 96; fax +33 FDA will classify the device by written
5 61 93 44 51; email account.airworth-eas@ In accordance with section 513(f)(1) of order within 120 days. This
airbus.com; Internet http://www.airbus.com. the Federal Food, Drug, and Cosmetic classification will be the initial
(7) For UTC service information identified Act (the FD&C Act) (21 U.S.C. classification of the device.
in this AD, contact UTC Aerospace Systems; 360c(f)(1)), devices that were not in On August 7, 2013, Wicab Inc.,
Roger Dangremont; telephone +01 34 32 63 commercial distribution before May 28, submitted a request for classification of
28; email roger.dangrement@goodrich.com. 1976 (the date of enactment of the the BrainPort V100 under section
(8) You may view this service information Medical Device Amendments of 1976), 513(f)(2) of the FD&C Act. The
at the FAA, Transport Airplane Directorate, generally referred to as postamendments manufacturer recommended that the
Lhorne on DSK5TPTVN1PROD with RULES
1601 Lind Avenue SW., Renton, WA. For devices, are classified automatically by
information on the availability of this
device be classified into class II (Ref. 1).
material at the FAA, call 425–227–1221.
statute into class III without any FDA In accordance with section 513(f)(2) of
(9) You may view this service information rulemaking process. These devices the FD&C Act, FDA reviewed the
that is incorporated by reference at the remain in class III and require request in order to classify the device
National Archives and Records premarket approval, unless and until under the criteria for classification set
Administration (NARA). For information on the device is classified or reclassified forth in section 513(a)(1). FDA classifies
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![57092 Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Rules and Regulations
III. Paperwork Reduction Act of 1995 involving the mouth, tongue, and gums SUMMARY: In this rule, BOEM amends its
This final order establishes special and demonstrate the effect of the existing regulations by: Updating
controls that refer to previously stimulation to provide clinically address locations; removing an outdated
approved collections of information meaningful outcomes. The clinical Web site address and correcting a form
found in other FDA regulations. These performance testing must also number; changing the term ‘‘Associate
collections of information are subject to investigate the anticipated conditions of Director’’ to ‘‘Deputy Director’’ in the
review by the Office of Management and use, including potential use error, regulations; and other housekeeping
Budget (OMB) under the Paperwork intended environment of use, and changes, such as removing reference to
Reduction Act of 1995 (44 U.S.C. 3501– duration of use. a URL hyperlink for a Web page that no
3520). The collections of information in (2) Non-clinical performance testing longer exists.
part 807, subpart E, regarding premarket must demonstrate that the device
DATES: This rule is effective September
notification submissions have been performs as intended under anticipated
22, 2015.
approved under OMB control number conditions of use, including simulated
0910–0120, and the collections of moisture ingress, device durability, and FOR FURTHER INFORMATION CONTACT:
information in 21 CFR part 801, battery reliability. Robert Samuels, Office of Policy,
regarding labeling have been approved (3) Software verification, validation, Regulation and Analysis, BOEM, 45600
under OMB control number 0910–0485. and hazard analysis must be performed. Woodland Road, Sterling, VA 20166;
(4) Analysis/testing must validate email: robert.samuels@boem.gov.
IV. Reference electromagnetic compatibility.
SUPPLEMENTARY INFORMATION:
The following reference has been (5) Analysis/testing must validate
placed on display in the Division of electrical safety. I. Rulemaking Procedure
Dockets Management (HFA–305), Food (6) Analysis/testing must assess and
and Drug Administration, 5630 Fishers validate wireless coexistence concerns. This rule pertains solely to
Lane, rm. 1061, Rockville, MD 20852, (7) Any elements of the device that administrative changes. It makes no
and may be seen by interested persons contact the patient must be changes to the substantive legal rights,
between 9 a.m. and 4 p.m., Monday demonstrated to be biocompatible. obligations, or interests of affected
through Friday, and is available (8) Training must include elements to parties. This rule, therefore, is a ‘‘rule of
electronically at http:// ensure that the healthcare provider and agency organization, procedure or
www.regulations.gov. user can identify the safe environments practice’’ and is, therefore, exempt from
for device use, use all safety features of the notice-and-comment requirements
1. DEN130039: De Novo Request per 513(f)(2) of 5 U.S.C. 553 under 5 U.S.C.
from Wicab Inc., dated August 7, 2013. the device, and operate the device in the
intended environment of use. 553(b)(A).
List of Subjects in 21 CFR Part 886 (9) Labeling for the trainer and user II. Overview of the Direct Final Rule
Medical devices. must include a summary of the clinical
Therefore, under the Federal Food, testing including adverse events In early 2015, many of BOEM’s
Drug, and Cosmetic Act and under encountered under use conditions, headquarters’ offices moved from
authority delegated to the Commissioner summary of study outcomes and Herndon, Virginia to Sterling, Virginia.
of Food and Drugs, 21 CFR part 886 is endpoints, and information pertinent to References in the 30 CFR part 550
amended as follows: use of the device including the regulations to the Herndon, Virginia
conditions under which the device was location are updated in this rule to
PART 886—OPHTHALMIC DEVICES studied (e.g., level of supervision or reflect the Sterling, Virginia location.
assistance, and environment of use). This rule also updates other addresses
■ 1. The authority citation for 21 CFR in 30 CFR part 519. Also, the existing
Dated: September 16, 2015.
part 886 continues to read as follows: regulations contain references to the
Leslie Kux,
Authority: 21 U.S.C. 351, 360, 360c, 360e, title ‘‘Associate Director,’’ which is a
Associate Commissioner for Policy.
360j, 371. remnant of BOEM’s predecessor agency,
[FR Doc. 2015–24026 Filed 9–21–15; 8:45 am]
the Minerals Management Service. This
■ 2. Add § 886.5905 to subpart F to read BILLING CODE 4164–01–P rule changes ‘‘Associate Director’’ to
as follows: ‘‘Deputy Director’’ in the current
§ 886.5905 Oral electronic vision aid. regulations. This rule also makes other
(a) Identification. An oral electronic DEPARTMENT OF THE INTERIOR housekeeping changes, such as
vision aid is a battery-powered removing reference to a URL hyperlink
Bureau of Ocean Energy Management for a Web page that no longer exists.
prescription device that contains an
electrode stimulation array to generate III. Section-by-Section Analysis of
30 CFR Parts 519, 550, 551, 553, 556,
electrotactile stimulation patterns that Direct Final Rule
560, 580, 581, 582, and 585
are derived from digital object images
captured by a camera. It is intended to 30 CFR Part 519 (Distribution and
[Docket No. BOEM–2015–0060; MMAA
aid profoundly blind patients in 104000]
Disbursement of Royalties, Rentals, and
orientation, mobility, and object Bonuses)
recognition as an adjunctive device to RIN 1010–AD94
Section 519.410 What does this
other assistive methods such as a white subpart contain?
cane or a guide dog. Updating Addresses and Contact
Lhorne on DSK5TPTVN1PROD with RULES
(b) Classification. Class II (special Information in the Bureau of Ocean Section 519.410(b) contains contact
controls). The special controls for this Energy Management’s Regulations information for the Office of Natural
device are: AGENCY: Bureau of Ocean Energy Resources Revenue Financial
(1) Clinical performance testing must Management (BOEM), Interior. Management Program Manager. The
demonstrate an acceptable adverse Direct Final Rule updates the address
ACTION: Direct final rule.
event profile, including adverse events and phone number.
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Document Created: 2015-12-15 09:35:32
Document Modified: 2015-12-15 09:35:32
| 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 September 22, 2015. The classification was applicable on June 18, 2015. | |
| Contact | Dexiu Shi, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2246, Silver Spring, MD, 20993-0002, 301-796-6470, [email protected] | |
| FR Citation | 80 FR 57090 |
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