80_FR_37759 80 FR 37633 - Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability

80 FR 37633 - Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 126 (July 1, 2015)

Page Range37633-37635
FR Document2015-16150

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements.'' This guidance describes FDA's intent to exempt certain unclassified medical devices (that FDA intends to classify into class I or II), certain class II medical devices, and certain class I medical devices from premarket notification requirements. FDA believes the devices identified in this guidance document are sufficiently well understood and do not require premarket notification to assure their safety and effectiveness.

Federal Register, Volume 80 Issue 126 (Wednesday, July 1, 2015) 
[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Notices]
[Pages 37633-37635]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16150]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0967]


Intent to Exempt Certain Unclassified, Class II, and Class I 
Reserved Medical Devices From Premarket Notification Requirements; 
Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Intent to Exempt Certain 
Unclassified, Class II, and Class I Reserved Medical Devices from 
Premarket Notification Requirements.'' This guidance describes FDA's 
intent to exempt certain unclassified medical devices (that FDA intends 
to classify into class I or II), certain class II medical devices, and 
certain class I medical devices from premarket notification 
requirements. FDA believes the devices identified in this guidance 
document are sufficiently well understood and do not require premarket 
notification to assure their safety and effectiveness.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Intent to Exempt Certain Unclassified, Class II, and Class I Reserved 
Medical Devices from Premarket Notification Requirements'' to the 
Office of the Center Director, Guidance and Policy Development, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in 
processing your request.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

[[Page 37634]]


FOR FURTHER INFORMATION CONTACT: Angela C. Krueger, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301-
796-6380.

SUPPLEMENTARY INFORMATION:

I. Background

    In the commitment letter (section 1.G of the Performance Goals and 
Procedures) that was drafted as part of the reauthorization process for 
the Medical Device User Fee Amendments of 2012, part of the Food and 
Drug Administration Safety and Innovation Act (Pub. L. 112-144), FDA 
committed to identifying low-risk medical devices to exempt from 
premarket notification requirements. This guidance describes FDA's 
intent to exempt certain unclassified medical devices (that FDA intends 
to classify into class I or II), certain class II medical devices, and 
certain class I medical devices (that no longer meet the ``reserved'' 
criteria in section 510(l) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 360(l))) from premarket notification 
requirements. FDA believes the devices identified in this guidance 
document are sufficiently well understood and do not require 510(k) 
notification to assure their safety and effectiveness.
    The draft of this guidance was made available in the Federal 
Register on August 1, 2014 (79 FR 44804). The comment period closed on 
September 30, 2014. FDA received one comment on the draft guidance 
requesting that devices classified under 21 CFR 880.6760 (Protective 
restraint, product code OYS, Patient Bed with Canopy/Restraints) be 
considered for inclusion in the guidance document. FDA considered the 
comment and determined it was appropriate to add this device type to 
the final guidance.
    In the process of finalizing the guidance document, the Center for 
Devices and Radiological Health (CDRH) reviewed additional medical 
device product codes not included in the draft guidance and determined 
that there were additional device types which are sufficiently well 
understood and do not require premarket notification (510(k)) to assure 
their safety and effectiveness. As a result, the following device types 
(product codes) were added to the final guidance document: EIB--
Syringe, Irrigating (Dental); EWD--Protector, Hearing (Insert); EWE--
Protector, Hearing (Circumaural); LEZ--Aids, Speech Training for the 
Hearing Impaired (AC-Powered and Patient-Contact); LFA--Aids, Speech 
Training for the Hearing Impaired (Battery-Operated or Non-Patient); 
KLX--Electroglottograph; LZI--Device, Assistive Listening; LRL--
Cushion, Hemorrhoid; KMJ--Lubricant, Patient; OYS--Patient Bed with 
Canopy/Restraint (see above); HCD--Cannula, Ventricular; GYK--
Instrument, Shunt System Implantation; LHM--System, Thermographic, 
Liquid Crystal; KYA--System, Thermographic, Liquid Crystal, Nonpowered 
(Adjunctive Use); NUR--Pad, Interlabial; and LZW--Monitor, Spine 
Curvature.
    Additionally, CDRH reviewed the device types (product codes) 
included in the draft guidance document and determined that two device 
types (product codes) originally proposed in the draft guidance 
document should not be included in the final guidance as devices for 
which FDA intends to exempt from premarket notification requirements: 
FLL--Thermometer, Electrical, Clinical (21 CFR 880.2910); and GWO--
Plate, Cranioplasty, Preformed, Alterable (21 CFR 882.5320). CDRH 
determined that premarket notification (510(k)) is necessary to assure 
the safety and effectiveness of these devices. Notably, the FLL product 
code currently covers thermometers with a range of technologies and 
intended uses, including those used to screen for potential pandemic 
contagious diseases. CDRH believes that some thermometer types may be 
candidates for exemption from premarket notification requirements at a 
later date, but that thermometers should first be further categorized 
by technology and/or intended use into distinct product codes. CDRH is 
actively reviewing this issue and will further consider which of the 
sub-types may be appropriate to exempt from premarket notification 
requirements. In addition, CDRH believes that premarket notification 
(510(k)) is necessary to provide a reasonable assurance of safety and 
effectiveness for cranioplasty plates (GWO), which are permanent 
implants and may be constructed of polymeric materials and/or may be 
resorbable, because FDA must evaluate the material properties and 
resorption rate in relation to bone healing. CDRH recognizes that 
manufacturers may not have submitted a 510(k) for these two device 
types following publication of the draft guidance. As a result, CDRH is 
providing such manufacturers 90 days following the publication of this 
notice to submit a 510(k) for these device types; however, distribution 
and marketing of such devices must cease if a manufacturer receives an 
order from FDA declaring the device to be not substantially equivalent 
to any legally marketed predicate device. Finally, CDRH changed the 
product code listed in the guidance document for Ophthalmic Cameras (21 
CFR 886.1120) from HKI--Camera, Ophthalmic, AC-Powered to PJZ--Camera, 
Ophthalmic, AC-Powered, General Use to clarify the type of AC-powered 
Ophthalmic Camera CDRH intended to exempt. CDRH also removed LQX--
Device, Finger-Sucking (21 CFR 890.3475) from the final guidance 
because this device type is already classified as class I (general 
controls) and exempt from premarket notification. Finger-sucking 
devices (LQX) and cranioplasty plates (GWO) were unintentionally 
included in the draft guidance.

III. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of the FDA on the Intent to Exempt Certain 
Unclassified, Class II, and Class I Reserved Medical Devices from 
Premarket Notification Requirements. It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

IV. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of 
``Intent to Exempt Certain Unclassified, Class II, and Class I Reserved 
Medical Devices from Premarket Notification Requirements'' may send an 
email request to [email protected] to receive an electronic 
copy of the document. Please use the document number 1300046 to 
identify the guidance you are requesting.

V. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E, have been

[[Page 37635]]

approved under OMB control number 0910-0120.

VI. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: June 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16150 Filed 6-30-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices 37633 Dated: June 25, 2015. availability of the guidance entitled information on electronic access to the Leslie Kux, ‘‘Intent to Exempt Certain Unclassified, guidance. Submit written requests for a Associate Commissioner for Policy. Class II, and Class I Reserved Medical single hard copy of the guidance [FR Doc. 2015–16125 Filed 6–30–15; 8:45 am] Devices from Premarket Notification document entitled ‘‘Intent to Exempt BILLING CODE 4164–01–C Requirements.’’ This guidance describes Certain Unclassified, Class II, and Class FDA’s intent to exempt certain I Reserved Medical Devices from unclassified medical devices (that FDA Premarket Notification Requirements’’ DEPARTMENT OF HEALTH AND intends to classify into class I or II), to the Office of the Center Director, HUMAN SERVICES certain class II medical devices, and Guidance and Policy Development, certain class I medical devices from Center for Devices and Radiological Food and Drug Administration premarket notification requirements. Health, Food and Drug Administration, [Docket No. FDA–2014–D–0967] FDA believes the devices identified in 10903 New Hampshire Ave., Bldg. 66, this guidance document are sufficiently Rm. 5431, Silver Spring, MD 20993– Intent to Exempt Certain Unclassified, well understood and do not require 0002. Send one self-addressed adhesive Class II, and Class I Reserved Medical premarket notification to assure their label to assist that office in processing Devices From Premarket Notification safety and effectiveness. your request. Requirements; Guidance for Industry DATES: Submit either electronic or Submit electronic comments on the and Food and Drug Administration written comments on this guidance at guidance to http://www.regulations.gov. Staff; Availability any time. General comments on Agency tkelley on DSK3SPTVN1PROD with NOTICES Submit written comments to the AGENCY: Food and Drug Administration, guidance documents are welcome at any Division of Dockets Management (HFA– HHS. time. 305), Food and Drug Administration, ACTION: Notice. ADDRESSES: An electronic copy of the 5630 Fishers Lane, Rm. 1061, Rockville, guidance document is available for MD 20852. Identify comments with the SUMMARY: The Food and Drug download from the Internet. See the docket number found in brackets in the Administration (FDA) is announcing the SUPPLEMENTARY INFORMATION section for heading of this document. EN01JY15.011</GPH> VerDate Sep<11>2014 18:30 Jun 30, 2015 Jkt 235001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\01JYN1.SGM 01JYN1

37634 Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices FOR FURTHER INFORMATION CONTACT: Operated or Non-Patient); KLX— marketed predicate device. Finally, Angela C. Krueger, Center for Devices Electroglottograph; LZI—Device, CDRH changed the product code listed and Radiological Health, Food and Drug Assistive Listening; LRL—Cushion, in the guidance document for Administration, 10903 New Hampshire Hemorrhoid; KMJ—Lubricant, Patient; Ophthalmic Cameras (21 CFR 886.1120) Ave., Bldg. 66, Rm. 1666, Silver Spring, OYS—Patient Bed with Canopy/ from HKI—Camera, Ophthalmic, AC- MD 20993–0002, 301–796–6380. Restraint (see above); HCD—Cannula, Powered to PJZ—Camera, Ophthalmic, SUPPLEMENTARY INFORMATION: Ventricular; GYK—Instrument, Shunt AC-Powered, General Use to clarify the System Implantation; LHM—System, type of AC-powered Ophthalmic I. Background Thermographic, Liquid Crystal; KYA— Camera CDRH intended to exempt. In the commitment letter (section 1.G System, Thermographic, Liquid Crystal, CDRH also removed LQX—Device, of the Performance Goals and Nonpowered (Adjunctive Use); NUR— Finger-Sucking (21 CFR 890.3475) from Procedures) that was drafted as part of Pad, Interlabial; and LZW—Monitor, the final guidance because this device the reauthorization process for the Spine Curvature. type is already classified as class I Medical Device User Fee Amendments Additionally, CDRH reviewed the (general controls) and exempt from of 2012, part of the Food and Drug device types (product codes) included premarket notification. Finger-sucking Administration Safety and Innovation in the draft guidance document and devices (LQX) and cranioplasty plates Act (Pub. L. 112–144), FDA committed determined that two device types (GWO) were unintentionally included to identifying low-risk medical devices (product codes) originally proposed in in the draft guidance. to exempt from premarket notification the draft guidance document should not requirements. This guidance describes III. Significance of Guidance be included in the final guidance as FDA’s intent to exempt certain devices for which FDA intends to This guidance is being issued unclassified medical devices (that FDA exempt from premarket notification consistent with FDA’s good guidance intends to classify into class I or II), practices regulation (21 CFR 10.115). requirements: FLL—Thermometer, certain class II medical devices, and The guidance represents the current Electrical, Clinical (21 CFR 880.2910); certain class I medical devices (that no thinking of the FDA on the Intent to and GWO—Plate, Cranioplasty, longer meet the ‘‘reserved’’ criteria in Exempt Certain Unclassified, Class II, Preformed, Alterable (21 CFR 882.5320). section 510(l) of the Federal Food, Drug, and Class I Reserved Medical Devices CDRH determined that premarket and Cosmetic Act (the FD&C Act) (21 from Premarket Notification notification (510(k)) is necessary to U.S.C. 360(l))) from premarket Requirements. It does not establish any assure the safety and effectiveness of notification requirements. FDA believes rights for any person and is not binding these devices. Notably, the FLL product the devices identified in this guidance on FDA or the public. You can use an code currently covers thermometers document are sufficiently well alternative approach if it satisfies the understood and do not require 510(k) with a range of technologies and intended uses, including those used to requirements of the applicable statutes notification to assure their safety and and regulations. effectiveness. screen for potential pandemic The draft of this guidance was made contagious diseases. CDRH believes that IV. Electronic Access available in the Federal Register on some thermometer types may be August 1, 2014 (79 FR 44804). The candidates for exemption from Persons interested in obtaining a copy comment period closed on September premarket notification requirements at a of the guidance may do so by 30, 2014. FDA received one comment on later date, but that thermometers should downloading an electronic copy from the draft guidance requesting that first be further categorized by the Internet. A search capability for all devices classified under 21 CFR technology and/or intended use into CDRH guidance documents is available 880.6760 (Protective restraint, product distinct product codes. CDRH is actively at http://www.fda.gov/MedicalDevices/ code OYS, Patient Bed with Canopy/ reviewing this issue and will further DeviceRegulationandGuidance/ Restraints) be considered for inclusion consider which of the sub-types may be GuidanceDocuments/default.htm. in the guidance document. FDA appropriate to exempt from premarket Guidance documents are also available considered the comment and notification requirements. In addition, at http://www.regulations.gov. Persons determined it was appropriate to add CDRH believes that premarket unable to download an electronic copy this device type to the final guidance. notification (510(k)) is necessary to of ‘‘Intent to Exempt Certain In the process of finalizing the provide a reasonable assurance of safety Unclassified, Class II, and Class I guidance document, the Center for and effectiveness for cranioplasty plates Reserved Medical Devices from Devices and Radiological Health (CDRH) (GWO), which are permanent implants Premarket Notification Requirements’’ reviewed additional medical device and may be constructed of polymeric may send an email request to CDRH- product codes not included in the draft materials and/or may be resorbable, Guidance@fda.hhs.gov to receive an guidance and determined that there because FDA must evaluate the material electronic copy of the document. Please were additional device types which are properties and resorption rate in use the document number 1300046 to sufficiently well understood and do not relation to bone healing. CDRH identify the guidance you are require premarket notification (510(k)) recognizes that manufacturers may not requesting. to assure their safety and effectiveness. have submitted a 510(k) for these two V. Paperwork Reduction Act of 1995 As a result, the following device types device types following publication of (product codes) were added to the final the draft guidance. As a result, CDRH is This guidance refers to previously guidance document: EIB—Syringe, providing such manufacturers 90 days approved collections of information tkelley on DSK3SPTVN1PROD with NOTICES Irrigating (Dental); EWD—Protector, following the publication of this notice found in FDA regulations. These Hearing (Insert); EWE—Protector, to submit a 510(k) for these device collections of information are subject to Hearing (Circumaural); LEZ—Aids, types; however, distribution and review by the Office of Management and Speech Training for the Hearing marketing of such devices must cease if Budget (OMB) under the Paperwork Impaired (AC-Powered and Patient- a manufacturer receives an order from Reduction Act of 1995 (44 U.S.C. 3501– Contact); LFA—Aids, Speech Training FDA declaring the device to be not 3520). The collections of information in for the Hearing Impaired (Battery- substantially equivalent to any legally 21 CFR part 807, subpart E, have been VerDate Sep<11>2014 18:30 Jun 30, 2015 Jkt 235001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\01JYN1.SGM 01JYN1

Federal Register / Vol. 80, No. 126 / Wednesday, July 1, 2015 / Notices 37635 approved under OMB control number Colesville Rd., COLE–14526, Silver section 351(k)(4) of the PHS Act.) 0910–0120. Spring, MD 20993–0002, PRAStaff@ Interchangeable products may be fda.hhs.gov. substituted for the reference product VI. Comments SUPPLEMENTARY INFORMATION: In without the intervention of the Interested persons may submit either prescribing health care provider. (See electronic comments regarding this compliance with 44 U.S.C. 3507, FDA has submitted the following proposed section 351(i)(3) of the PHS Act.) document to http://www.regulations.gov In estimating the information or written comments to the Division of collection of information to OMB for collection burden for 351(k) Dockets Management (see ADDRESSES). It review and clearance. applications, we reviewed the number is only necessary to send one set of General Licensing Provisions; Section of 351(k) applications FDA has received comments. Identify comments with the 351(k) Biosimilar Applications OMB through fiscal year (FY) 2014, as well as docket number found in brackets in the Control Number 0910–0719—Extension the collection of information regarding heading of this document. Received the general licensing provisions for The Patient Protection and Affordable comments may be seen in the Division biologics license applications under Care Act (Affordable Care Act) (Pub. L. of Dockets Management between 9 a.m. section 351(a) of the PHS Act submitted 111–148) contains a subtitle called the and 4 p.m., Monday through Friday, and to OMB (approved under OMB control Biologics Price Competition and will be posted to the docket at http:// number 0910–0338). For the Innovation Act of 2009 (BPCI Act), www.regulations.gov. information collection burden for 351(a) which amends the Public Health Service Dated: June 26, 2015. applications, FDA described § 601.2(a) Act (PHS Act) and establishes an Leslie Kux, (21 CFR 601.2(a)) as requiring a abbreviated licensure pathway for manufacturer of a biological product to Associate Commissioner for Policy. biological products shown to be submit an application on forms [FR Doc. 2015–16150 Filed 6–30–15; 8:45 am] biosimilar to, or interchangeable with, prescribed for such purpose with BILLING CODE 4164–01–P an FDA-licensed biological reference accompanying data and information product (See sections 7001 through including certain labeling information 7003 of the Affordable Care Act.) to FDA for approval to market a product DEPARTMENT OF HEALTH AND Section 351(k) of the PHS Act (42 in interstate commerce. FDA also added HUMAN SERVICES U.S.C. 262(k)), added by the BPCI Act, in the burden estimate the container and sets forth the requirements for an package labeling requirements provided Food and Drug Administration application for a proposed biosimilar under §§ 610.60 through 610.65 (21 CFR [Docket No. FDA–2012–N–0129] product and an application or a 610.60 through 610.65). The estimated supplement for a proposed hours per response for § 601.2, and Agency Information Collection interchangeable product. Section 351(k) §§ 610.60 through 610.65, are 860 hours. Activities; Submission for Office of defines biosimilarity to mean ‘‘that the In addition, in submitting a 351(a) Management and Budget Review; biological product is highly similar to application, an applicant completes the Comment Request; General Licensing the reference product notwithstanding Form FDA 356h, ‘‘Application to Market Provisions; Section 351(k) Biosimilar minor differences in clinically inactive a New Drug, Biologic, or an Antibiotic Applications components’’ and that ‘‘there are no Drug for Human Use.’’ The application clinically meaningful differences form serves primarily as a checklist for AGENCY: Food and Drug Administration, between the biological product and the firms to gather and submit certain HHS. reference product in terms of the safety, information to FDA. The checklist helps ACTION: Notice. purity, and potency of the product.’’ to ensure that the application is SUMMARY: The Food and Drug (See section 351(i)(2) of the PHS Act.) A complete and contains all the necessary Administration (FDA) is announcing 351(k) application must contain, among information so that delays due to lack of that a proposed collection of other things, information demonstrating information may be eliminated. The information has been submitted to the that the biological product is biosimilar form provides key information to FDA Office of Management and Budget to a reference product based upon data for efficient handling and distribution to (OMB) for review and clearance under derived from analytical studies, animal the appropriate staff for review. The the Paperwork Reduction Act of 1995. studies, and clinical studies, unless estimated burden hours for biological DATES: Fax written comments on the FDA determines, in its discretion, that product submissions using FDA Form collection of information by July 31, certain studies are unnecessary in a 356h are included under the applicable 2015. 351(k) application. (See section requirements approved under OMB 351(k)(2) of the PHS Act.) To control number 0910–0338. ADDRESSES: To ensure that comments on demonstrate interchangeability, an To submit an application seeking the information collection are received, applicant must provide sufficient licensure of a proposed biosimilar OMB recommends that written information to demonstrate product under section 351(k)(2)(A)(i) comments be faxed to the Office of biosimilarity and that the biosimilar and (k)(2)(A)(iii) of the PHS Act, FDA Information and Regulatory Affairs, biological product can be expected to believes that the estimated burden hours OMB, Attn: FDA Desk Officer, FAX: produce the same clinical result as the would be approximately the same as 202–395–7285, or emailed to oira_ reference product in any given patient noted under OMB control number submission@omb.eop.gov. All and, if the biosimilar biological product 0910–0338 for a 351(a) application—860 comments should be identified with the is administered more than once to an hours. The burden estimates for seeking OMB control number 0910–0719. Also tkelley on DSK3SPTVN1PROD with NOTICES individual, the risk in terms of safety or licensure of a proposed biosimilar include the FDA docket number found diminished efficacy of alternating or product that meets the standards for in brackets in the heading of this switching between the use of the interchangeability under section document. biosimilar biological product and the 351(k)(2)(B) and (k)(4) would also be FOR FURTHER INFORMATION CONTACT: FDA reference product is not greater than the 860 hours. Until we gain more PRA Staff, Office of Operations, Food risk of using the reference product experience with biosimilar applications, and Drug Administration, 8455 without such alternation or switch. (See FDA believes this estimate is VerDate Sep<11>2014 18:30 Jun 30, 2015 Jkt 235001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\01JYN1.SGM 01JYN1


Document Created: 2015-12-15 13:20:03
Document Modified: 2015-12-15 13:20:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
ContactAngela C. Krueger, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301- 796-6380.
FR Citation80 FR 37633 
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