Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 56610-56612 [2017-25774]

Download as PDF 56610 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices pmangrum on DSK3GDR082PROD with NOTICES1 medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human drug product VELTASSA (patiromer sorbitex calcium). VELTASSA is indicated for the treatment of hyperkalemia. Subsequent to this approval, the USPTO received a patent term restoration application for VELTASSA (U.S. Patent No. 8,147,873) from Relypsa, Inc., and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated September 1, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of VELTASSA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for VELTASSA is 2,844 days. Of this time, 2,478 days occurred during the testing phase of the regulatory review period, while 366 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: January 9, 2008. FDA has verified the applicant’s claim that January 9, 2008, VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 is the date the investigational new drug application (IND) became effective. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: October 21, 2014. FDA has verified the applicant’s claim that the new drug application (NDA) for VELTASSA (NDA 205739) was initially submitted on October 21, 2014. 3. The date the application was approved: October 21, 2015. FDA has verified the applicant’s claim that NDA 205739 was approved on October 21, 2015. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 832 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: November 24, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–25761 Filed 11–28–17; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–5625] Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.’’ It describes study designs for generating data that supports both 510(k) clearance and CLIA waived categorization. Use of the Dual 510(k) and CLIA Waiver by Application pathway is optional; however, FDA believes this pathway is in many instances the least burdensome and fastest approach for manufacturers to obtain a CLIA waived categorization in addition to 510(k) clearance for new In Vitro Diagnostic (IVD) devices. FDA believes increased use of this pathway will speed up the process of bringing simple and accurate IVD devices to CLIA waived settings, which will better serve patients and providers. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by January 29, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such E:\FR\FM\29NON1.SGM 29NON1 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices pmangrum on DSK3GDR082PROD with NOTICES1 as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2017–D–5625 for ‘‘Recommendations for Dual 510(k) and CLIA Waiver by Application Studies.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR–2015–09–18/pdf/2015– 23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21CFR 10.115(g)(5)). 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 draft guidance document entitled ‘‘Recommendations for Dual 510(k) and CLIA Waiver by Application Studies’’ 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 selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Peter Tobin, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5645, Silver Spring, MD 20993–0002, 240–402–6169. SUPPLEMENTARY INFORMATION: I. Background In an application for CLIA waived categorization (CLIA Waiver by Application) a manufacturer submits evidence to FDA that a test, initially categorized as moderate complexity, meets the CLIA statutory criteria for waiver, 42 U.S.C. 263a(d)(3), and requests that FDA categorize the test as waived. Historically, CLIA Waiver by Application has followed clearance or approval of an IVD test. This stepwise approach currently remains the most utilized path by manufacturers. For additional information, please see FDA’s Guidance, ‘‘Administrative Procedures for CLIA Categorization’’ (https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/UCM070889). PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 56611 While a premarket notification (510(k)) and CLIA Waiver by Application each include discrete elements not required in the other, both submissions include comparison and reproducibility studies. For a 510(k), such studies are often performed by trained operators (i.e., laboratory professionals who meet the qualifications to perform moderate complexity testing and with previous training in performing the test; sometimes referred to as ‘‘moderate complexity users’’). For a CLIA Waiver by Application, such studies must be conducted by untrained operators (i.e., operators in waived settings with limited or no training or hands on experience in conducting laboratory testing; sometimes referred to as ‘‘waived users’’). An applicant may choose to conduct a single set of comparison and reproducibility studies with untrained operators to satisfy associated requirements for both 510(k) and CLIA Waiver by Application. To streamline the review of such data, the Dual 510(k) and CLIA Waiver by Application (Dual Submission) pathway, was established as part of the Medical Device User Fee Amendments of 2012 (MDUFA III), allowing the review of both a 510(k) and CLIA Waiver Application within a single submission with a reduced overall review time. This guidance leverages FDA’s experience implementing this pathway in MDUFA III in order to make the Dual Submission pathway least burdensome. Use of this guidance is expected to reduce study-related costs and provide time savings for manufacturers of certain Class II IVD devices intended for CLIA waived settings. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on Recommendations for Dual 510(k) and CLIA Waiver by Application Studies. 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. This guidance is not subject to Executive Order 12866. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available E:\FR\FM\29NON1.SGM 29NON1 56612 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Recommendations for Dual 510(k) and CLIA Waiver by Application Studies’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 16038 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR 54 have been approved under 0910–0396; the collections of information in 21 CFR parts 50 and 56 have been approved under OMB control number 0910–0755, the collections of information in 21 CFR 807 have been approved under 0910–0120; the collections of information in the guidance document entitled ‘‘Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’ have been approved under 0910–0598, the collections of information in the guidance document entitled ‘‘Requests for Feedback on Medical Device Submissions’’ have been approved under 0910–0756; and the collections of information in the guidance document entitled ‘‘Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization’’ have been approved under 0910–0607. Dated: November 22, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–25774 Filed 11–28–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration pmangrum on DSK3GDR082PROD with NOTICES1 [Docket No. FDA–2016–E–1292] Determination of Regulatory Review Period for Purposes of Patent Extension; REXULTI AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period SUMMARY: VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 for REXULTI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. DATES: Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by January 29, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by May 29, 2018. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 29, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2016–E–1292 for ’’Determination of Regulatory Review Period for Purposes of Patent Extension; REXULTI.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ E:\FR\FM\29NON1.SGM 29NON1

Agencies

[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56610-56612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25774]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5625]

Recommendations for Dual 510(k) and Clinical Laboratory
Improvement Amendments Waiver by Application Studies; Draft Guidance
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Recommendations for
Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA)
Waiver by Application Studies.'' It describes study designs for
generating data that supports both 510(k) clearance and CLIA waived
categorization. Use of the Dual 510(k) and CLIA Waiver by Application
pathway is optional; however, FDA believes this pathway is in many
instances the least burdensome and fastest approach for manufacturers
to obtain a CLIA waived categorization in addition to 510(k) clearance
for new In Vitro Diagnostic (IVD) devices. FDA believes increased use
of this pathway will speed up the process of bringing simple and
accurate IVD devices to CLIA waived settings, which will better serve
patients and providers. This draft guidance is not final nor is it in
effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by January 29, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such

[[Page 56611]]

as a manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-D-5625 for ``Recommendations for Dual 510(k) and CLIA Waiver
by Application Studies.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21CFR
10.115(g)(5)).
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 draft guidance document entitled
``Recommendations for Dual 510(k) and CLIA Waiver by Application
Studies'' 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.

FOR FURTHER INFORMATION CONTACT: Peter Tobin, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5645, Silver Spring, MD 20993-0002, 240-402-6169.

SUPPLEMENTARY INFORMATION:

I. Background

In an application for CLIA waived categorization (CLIA Waiver by
Application) a manufacturer submits evidence to FDA that a test,
initially categorized as moderate complexity, meets the CLIA statutory
criteria for waiver, 42 U.S.C. 263a(d)(3), and requests that FDA
categorize the test as waived. Historically, CLIA Waiver by Application
has followed clearance or approval of an IVD test. This stepwise
approach currently remains the most utilized path by manufacturers. For
additional information, please see FDA's Guidance, ``Administrative
Procedures for CLIA Categorization'' (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM070889).
While a premarket notification (510(k)) and CLIA Waiver by
Application each include discrete elements not required in the other,
both submissions include comparison and reproducibility studies. For a
510(k), such studies are often performed by trained operators (i.e.,
laboratory professionals who meet the qualifications to perform
moderate complexity testing and with previous training in performing
the test; sometimes referred to as ``moderate complexity users''). For
a CLIA Waiver by Application, such studies must be conducted by
untrained operators (i.e., operators in waived settings with limited or
no training or hands on experience in conducting laboratory testing;
sometimes referred to as ``waived users'').
An applicant may choose to conduct a single set of comparison and
reproducibility studies with untrained operators to satisfy associated
requirements for both 510(k) and CLIA Waiver by Application. To
streamline the review of such data, the Dual 510(k) and CLIA Waiver by
Application (Dual Submission) pathway, was established as part of the
Medical Device User Fee Amendments of 2012 (MDUFA III), allowing the
review of both a 510(k) and CLIA Waiver Application within a single
submission with a reduced overall review time.
This guidance leverages FDA's experience implementing this pathway
in MDUFA III in order to make the Dual Submission pathway least
burdensome. Use of this guidance is expected to reduce study-related
costs and provide time savings for manufacturers of certain Class II
IVD devices intended for CLIA waived settings.

II. Significance of Guidance

This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies.
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. This
guidance is not subject to Executive Order 12866.

III. Electronic Access

Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available

[[Page 56612]]

at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
https://www.regulations.gov. Persons unable to download an electronic
copy of ``Recommendations for Dual 510(k) and CLIA Waiver by
Application Studies'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document.
Please use the document number 16038 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in 21 CFR 54 have been approved under 0910-0396; the collections of
information in 21 CFR parts 50 and 56 have been approved under OMB
control number 0910-0755, the collections of information in 21 CFR 807
have been approved under 0910-0120; the collections of information in
the guidance document entitled ``Recommendations for Clinical
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications
for Manufacturers of In Vitro Diagnostic Devices'' have been approved
under 0910-0598, the collections of information in the guidance
document entitled ``Requests for Feedback on Medical Device
Submissions'' have been approved under 0910-0756; and the collections
of information in the guidance document entitled ``Administrative
Procedures for Clinical Laboratory Improvement Amendments of 1988
Categorization'' have been approved under 0910-0607.

Dated: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25774 Filed 11-28-17; 8:45 am]
BILLING CODE 4164-01-P

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