82 FR 56610 - Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 228 (November 29, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 228 (November 29, 2017)
| Page Range | 56610-56612 | |
| FR Document | 2017-25774 |
[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)] [Notices] [Pages 56610-56612] From the Federal Register Online [www.thefederalregister.org] [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Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.''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 This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by January 29, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.thefederalregister.org/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 [email protected] 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
![56610 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices
medical device, food additive, or color is the date the investigational new drug DEPARTMENT OF HEALTH AND
additive) was subject to regulatory application (IND) became effective. HUMAN SERVICES
review by FDA before the item was 2. The date the application was
marketed. Under these acts, a product’s Food and Drug Administration
initially submitted with respect to the
regulatory review period forms the basis [Docket No. FDA–2017–D–5625]
human drug product under section
for determining the amount of extension
505(b) of the FD&C Act: October 21,
an applicant may receive. Recommendations for Dual 510(k) and
A regulatory review period consists of 2014. FDA has verified the applicant’s
Clinical Laboratory Improvement
two periods of time: a testing phase and claim that the new drug application
Amendments Waiver by Application
an approval phase. For human drug (NDA) for VELTASSA (NDA 205739)
Studies; Draft Guidance for Industry
products, the testing phase begins when was initially submitted on October 21, and Food and Drug Administration
the exemption to permit the clinical 2014. Staff; Availability
investigations of the drug becomes 3. The date the application was
effective and runs until the approval approved: October 21, 2015. FDA has AGENCY: Food and Drug Administration,
phase begins. The approval phase starts HHS.
verified the applicant’s claim that NDA
with the initial submission of an 205739 was approved on October 21, ACTION: Notice of availability.
application to market the human drug 2015. SUMMARY: The Food and Drug
product and continues until FDA grants
This determination of the regulatory Administration (FDA or Agency) is
permission to market the drug product.
review period establishes the maximum announcing the availability of the draft
Although only a portion of a regulatory
potential length of a patent extension. guidance entitled ‘‘Recommendations
review period may count toward the
However, the USPTO applies several for Dual 510(k) and Clinical Laboratory
actual amount of extension that the
statutory limitations in its calculations Improvement Amendments (CLIA)
Director of USPTO may award (for
of the actual period for patent extension. Waiver by Application Studies.’’ It
example, half the testing phase must be
subtracted as well as any time that may In its application for patent extension, describes study designs for generating
have occurred before the patent was this applicant seeks 832 days of patent data that supports both 510(k) clearance
issued), FDA’s determination of the term extension. and CLIA waived categorization. Use of
length of a regulatory review period for the Dual 510(k) and CLIA Waiver by
a human drug product will include all III. Petitions Application pathway is optional;
of the testing phase and approval phase however, FDA believes this pathway is
Anyone with knowledge that any of in many instances the least burdensome
as specified in 35 U.S.C. 156(g)(1)(B). the dates as published are incorrect may
FDA has approved for marketing the and fastest approach for manufacturers
submit either electronic or written to obtain a CLIA waived categorization
human drug product VELTASSA
comments and, under 21 CFR 60.24, ask in addition to 510(k) clearance for new
(patiromer sorbitex calcium).
VELTASSA is indicated for the for a redetermination (see DATES). In Vitro Diagnostic (IVD) devices. FDA
treatment of hyperkalemia. Subsequent Furthermore, as specified in § 60.30 (21 believes increased use of this pathway
to this approval, the USPTO received a CFR 60.30), any interested person may will speed up the process of bringing
patent term restoration application for petition FDA for a determination simple and accurate IVD devices to
VELTASSA (U.S. Patent No. 8,147,873) regarding whether the applicant for CLIA waived settings, which will better
from Relypsa, Inc., and the USPTO extension acted with due diligence serve patients and providers. This draft
requested FDA’s assistance in during the regulatory review period. To guidance is not final nor is it in effect
determining this patent’s eligibility for meet its burden, the petition must at this time.
patent term restoration. In a letter dated comply with all the requirements of DATES: Submit either electronic or
September 1, 2016, FDA advised the § 60.30, including but not limited to: written comments on the draft guidance
USPTO that this human drug product Must be timely (see DATES), must be by January 29, 2018 to ensure that the
had undergone a regulatory review filed in accordance with § 10.20, must Agency considers your comment on this
period and that the approval of contain sufficient facts to merit an FDA draft guidance before it begins work on
VELTASSA represented the first investigation, and must certify that a the final version of the guidance.
permitted commercial marketing or use true and complete copy of the petition ADDRESSES: You may submit comments
of the product. Thereafter, the USPTO has been served upon the patent on any guidance at any time as follows:
requested that FDA determine the applicant. (See H. Rept. 857, part 1, 98th Electronic Submissions
product’s regulatory review period. Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format Submit electronic comments in the
II. Determination of Regulatory Review following way:
Period specified in 21 CFR 10.30.
• Federal eRulemaking Portal:
FDA has determined that the Submit petitions electronically to https://www.regulations.gov. Follow the
applicable regulatory review period for https://www.regulations.gov at Docket instructions for submitting comments.
VELTASSA is 2,844 days. Of this time, No. FDA–2013–S–0610. Submit written Comments submitted electronically,
2,478 days occurred during the testing petitions (two copies are required) to the including attachments, to https://
phase of the regulatory review period, Dockets Management Staff (HFA–305), www.regulations.gov will be posted to
while 366 days occurred during the Food and Drug Administration, 5630 the docket unchanged. Because your
pmangrum on DSK3GDR082PROD with NOTICES1
approval phase. These periods of time Fishers Lane, Rm. 1061, Rockville, MD comment will be made public, you are
were derived from the following dates: 20852. solely responsible for ensuring that your
1. The date an exemption under Dated: November 24, 2017. comment does not include any
section 505(i) of the Federal Food, Drug, confidential information that you or a
Leslie Kux,
and Cosmetic Act (the FD&C Act) (21 third party may not wish to be posted,
U.S.C. 355(i)) became effective: January Associate Commissioner for Policy. such as medical information, your or
9, 2008. FDA has verified the [FR Doc. 2017–25761 Filed 11–28–17; 8:45 am] anyone else’s Social Security number, or
applicant’s claim that January 9, 2008, BILLING CODE 4164–01–P confidential business information, such
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![56612 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices
at https://www.fda.gov/MedicalDevices/ for REXULTI and is publishing this written/paper submission and in the
DeviceRegulationandGuidance/ notice of that determination as required manner detailed (see ‘‘Written/Paper
GuidanceDocuments/default.htm. by law. FDA has made the Submissions’’ and ‘‘Instructions’’).
Guidance documents are also available determination because of the
Written/Paper Submissions
at https://www.regulations.gov. Persons submission of an application to the
unable to download an electronic copy Director of the U.S. Patent and Submit written/paper submissions as
of ‘‘Recommendations for Dual 510(k) Trademark Office (USPTO), Department follows:
and CLIA Waiver by Application of Commerce, for the extension of a • Mail/Hand delivery/Courier (for
Studies’’ may send an email request to patent which claims that human drug written/paper submissions): Dockets
CDRH-Guidance@fda.hhs.gov to receive product. Management Staff (HFA–305), Food and
an electronic copy of the document. DATES: Anyone with knowledge that any Drug Administration, 5630 Fishers
Please use the document number 16038 of the dates as published (in the Lane, Rm. 1061, Rockville, MD 20852.
to identify the guidance you are
SUPPLEMENTARY INFORMATION section) are • For written/paper comments
requesting. submitted to the Dockets Management
incorrect may submit either electronic
IV. Paperwork Reduction Act of 1995 or written comments and ask for a Staff, FDA will post your comment, as
redetermination by January 29, 2018. well as any attachments, except for
This draft guidance also refers to information submitted, marked and
previously approved collections of Furthermore, any interested person may
petition FDA for a determination identified, as confidential, if submitted
information found in FDA regulations. as detailed in ‘‘Instructions.’’
The collections of information in 21 regarding whether the applicant for
extension acted with due diligence Instructions: All submissions received
CFR 54 have been approved under
during the regulatory review period by must include the Docket No. FDA–
0910–0396; the collections of
May 29, 2018. See ‘‘Petitions’’ in the 2016–E–1292 for ’’Determination of
information in 21 CFR parts 50 and 56
SUPPLEMENTARY INFORMATION section for Regulatory Review Period for Purposes
have been approved under OMB control
more information. of Patent Extension; REXULTI.’’
number 0910–0755, the collections of
information in 21 CFR 807 have been ADDRESSES: You may submit comments Received comments, those filed in a
approved under 0910–0120; the as follows. Please note that late, timely manner (see ADDRESSES), will be
collections of information in the untimely filed comments will not be placed in the docket and, except for
guidance document entitled considered. Electronic comments must those submitted as ‘‘Confidential
‘‘Recommendations for Clinical be submitted on or before January 29, Submissions,’’ publicly viewable at
Laboratory Improvement Amendments 2018. The https://www.regulations.gov https://www.regulations.gov or at the
of 1988 (CLIA) Waiver Applications for electronic filing system will accept Dockets Management Staff between 9
Manufacturers of In Vitro Diagnostic comments until midnight Eastern Time a.m. and 4 p.m., Monday through
Devices’’ have been approved under at the end of January 29, 2018. Friday.
0910–0598, the collections of Comments received by mail/hand • Confidential Submissions—To
information in the guidance document delivery/courier (for written/paper submit a comment with confidential
entitled ‘‘Requests for Feedback on submissions) will be considered timely information that you do not wish to be
Medical Device Submissions’’ have been if they are postmarked or the delivery made publicly available, submit your
approved under 0910–0756; and the service acceptance receipt is on or comments only as a written/paper
collections of information in the before that date. submission. You should submit two
guidance document entitled copies total. One copy will include the
Electronic Submissions information you claim to be confidential
‘‘Administrative Procedures for Clinical
Laboratory Improvement Amendments Submit electronic comments in the with a heading or cover note that states
of 1988 Categorization’’ have been following way: ‘‘THIS DOCUMENT CONTAINS
approved under 0910–0607. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
https://www.regulations.gov. Follow the Agency will review this copy, including
Dated: November 22, 2017.
instructions for submitting comments. the claimed confidential information, in
Leslie Kux, Comments submitted electronically, its consideration of comments. The
Associate Commissioner for Policy. including attachments, to https:// second copy, which will have the
[FR Doc. 2017–25774 Filed 11–28–17; 8:45 am] www.regulations.gov will be posted to claimed confidential information
BILLING CODE 4164–01–P the docket unchanged. Because your redacted/blacked out, will be available
comment will be made public, you are for public viewing and posted on
solely responsible for ensuring that your https://www.regulations.gov. Submit
DEPARTMENT OF HEALTH AND comment does not include any both copies to the Dockets Management
HUMAN SERVICES confidential information that you or a Staff. If you do not wish your name and
third party may not wish to be posted, contact information to be made publicly
Food and Drug Administration
such as medical information, your or available, you can provide this
[Docket No. FDA–2016–E–1292] anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
Determination of Regulatory Review as a manufacturing process. Please note must identify this information as
Period for Purposes of Patent that if you include your name, contact ‘‘confidential.’’ Any information marked
pmangrum on DSK3GDR082PROD with NOTICES1
Extension; REXULTI information, or other information that as ‘‘confidential’’ will not be disclosed
AGENCY: Food and Drug Administration, identifies you in the body of your except in accordance with § 10.20 (21
HHS. comments, that information will be CFR 10.20) and other applicable
ACTION: Notice. posted on https://www.regulations.gov. disclosure law. For more information
• If you want to submit a comment about FDA’s posting of comments to
SUMMARY: The Food and Drug with confidential information that you public dockets, see 80 FR 56469,
Administration (FDA or the Agency) has do not wish to be made available to the September 18, 2015, or access the
determined the regulatory review period public, submit the comment as a information at: https://www.gpo.gov/
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Document Created: 2017-11-29 01:26:33
Document Modified: 2017-11-29 01:26:33
| 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 | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 82 FR 56610 |
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