81 FR 49228 - Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 144 (July 27, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 144 (July 27, 2016)
| Page Range | 49228-49230 | |
| FR Document | 2016-17750 |
[Federal Register Volume 81, Number 144 (Wednesday, July 27, 2016)] [Notices] [Pages 49228-49230] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17750] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-2153] Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices.'' FDA is issuing this draft guidance to clarify how we evaluate real- world data (RWD) to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in regulatory decisionmaking for medical devices. This guidance also clarifies when an [[Page 49229]] investigational device exemption (IDE) may be needed to prospectively collect and use RWD for purposes of determining the safety and effectiveness of a device. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 25, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-D-2153 for ``Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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 ``Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices'' 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: Benjamin Eloff, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2254, Silver Spring, MD 20993-0002, 301-796-8528. SUPPLEMENTARY INFORMATION: I. Background To protect and promote the public health, FDA needs to understand and evaluate the available evidence related to regulated products. For medical devices, available evidence is traditionally comprised of non- clinical and in some cases, clinical studies conducted and provided to FDA by the device manufacturer or sponsor. However, FDA recognizes that a wealth of data covering medical device experience exists and is routinely collected in the course of treatment and management of patients. Under certain circumstances, these RWD may be of sufficient quality to help inform or augment FDA's understanding of the benefit- risk profile of devices at various points in their life cycle, and could potentially be used to aid FDA in regulatory decisionmaking. This document describes the characteristics and sources of RWD that may be sufficient for use in making various regulatory decisions. Because of its nature, the quality (i.e., relevance and reliability) of RWD can vary greatly across sources. Likewise, there are many types of regulatory decisions with varying levels of evidentiary needs. FDA's evidentiary standards for regulatory decisionmaking are not changing; FDA will evaluate whether the available RWD is of sufficient relevance and reliability to address the specific regulatory decision being considered. This guidance does not affect any federal, state or local laws or regulations or foreign laws or regulations that may otherwise be applicable to the use or collection of real-world evidence and that provide protections for human subjects or patient privacy. When finalized, this guidance should be used to complement, but not supersede, other device-specific and good clinical practice guidance documents. [[Page 49230]] 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 ``Use of Real- World Evidence to Support Regulatory Decisionmaking for Medical Devices.'' 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. 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 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 ``Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500012 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subparts A through E (premarket approval) have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 814, subpart H (humanitarian device exemption) have been approved under OMB control number 0910- 0332; the collections of information in 21 CFR part 812 (investigational device exemption) have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 822 (postmarket surveillance) have been approved under OMB control number 0910-0449; the collections of information in 21 CFR part 50.23 (exception from general requirements for informed consent) have been approved under OMB control number 0910-0586; the collections of information in 21 CFR part 54 (financial disclosure by clinical investigators) have been approved under OMB control number 0910-0396; the collections of information in 21 CFR part 56.115 (IRB records) have been approved under OMB control number 0910-0130; and the collections of information in 21 CFR parts 50 (informed consent) and 56 (IRBs) have been approved under OMB control number 0910-0755. The collections of information in the guidance ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' have been approved under OMB control number 0910-0756. Dated: July 22, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-17750 Filed 7-26-16; 8:45 am] BILLING CODE 4164-01-P
![49228 Federal Register / Vol. 81, No. 144 / Wednesday, July 27, 2016 / Notices
domestic FDF facility fee, we divide the TABLE 4—FEE SCHEDULE FOR FY address, the courier can deliver checks
$174,586,000 by the total number of 2017 to: U.S. Bank, Attention: Government
facilities (675) which results in a Lockbox 979108, 1005 Convention
domestic FDF facility fee of $258,646. Fee rates for Plaza, St. Louis, MO 63101. (Note: This
Fee category
The foreign FDF facility fee is $15,000 FY 2017 U.S. Bank address is for courier delivery
more than the domestic FDF facility fee, only. If you have any questions
Applications:
or $273,646. concerning courier delivery contact the
Abbreviated New Drug Ap-
VII. API Facility Fee plication (ANDA) ............ $70,480 U.S. Bank at 314–418–4013. This
Prior Approval Supplement telephone number is only for questions
Under GDUFA, the annual API (PAS) to an ANDA ........ 35,240 about courier delivery). Please make
facility fee is owed by each person that Drug Master File (DMF) ....... 51,140 sure that the FDA post office box
owns a facility which produces, or Facilities: number (P.O. Box 979108) is written on
which is pending review to produce, Active Pharmaceutical In- the check, bank draft, or postal money
one or more active pharmaceutical gredient (API)—Domes- order.
tic ................................... 44,234
ingredients identified, or intended to be If paying by wire transfer, please
API—Foreign ..................... 59,234
identified, in at least one generic drug Finished Dosage Form reference your unique user fee ID
submission that is pending or approved (FDF)—Domestic ........... 258,646 number when completing your transfer.
or in a Type II active pharmaceutical FDF—Foreign ................... 273,646 The originating financial institution
ingredient drug master file referenced in may charge a wire transfer fee. Please
such generic drug submission. These IX. Fee Payment Options and ask your financial institution about the
fees are due no later than the first Procedures wire transfer fee and include it with
business day on or after October 1 of your payment to ensure that your fee is
The new fee rates are effective
each such year. Section 744B(b)(2)(D) of fully paid. The account information is
October 1, 2016. To pay the ANDA,
the FD&C Act specifies that the API as follows: U.S. Department of Treasury,
PAS, DMF, API facility, and FDF facility
facility fee will make up 14 percent of fee, you must complete a Generic Drug TREAS NYC, 33 Liberty St., New York,
$323,011,000 in fee revenue, which is User Fee Cover Sheet, available at NY 10045, account number: 75060099,
$45,221,000 (rounded down to the http://www.fda.gov/gdufa, and generate routing number: 021030004, SWIFT:
nearest thousand dollars). a user fee identification (ID) number. FRNYUS33, Beneficiary: FDA, 8455
In order to calculate the API fee, FDA Payment must be made in U.S. currency Colesville Rd., 14th Floor, Silver Spring,
used data submitted by generic drug drawn on a U.S. bank by electronic MD 20993–0002. The tax identification
facilities through the self-identification check, check, bank draft, U.S. postal number of FDA is 53–0196965.
process mandated in the GDUFA statute money order, or wire transfer. The Dated: July 22, 2016.
and specified in a Notice of preferred payment method is online Leslie Kux,
Requirement published on October 2, using electronic check (Automated Associate Commissioner for Policy.
2012. The total number of API facilities Clearing House (ACH) also known as [FR Doc. 2016–17801 Filed 7–26–16; 8:45 am]
identified through self-identification eCheck) or credit card (Discover, VISA, BILLING CODE 4164–01–P
was 789. Of the total facilities identified MasterCard, American Express). Secure
as API facilities, there were 101 electronic payments can be submitted
domestic facilities and 688 foreign using the User Fees Payment Portal at DEPARTMENT OF HEALTH AND
facilities. The foreign facility differential https://userfees.fda.gov/pay. Once you HUMAN SERVICES
is $15,000. In order to calculate the fee search for your invoice, click ‘‘Pay
for domestic facilities, we must first Now’’ to be redirected to Pay.gov. Note Food and Drug Administration
subtract the fee revenue that will result that electronic payment options are
from the foreign facility fee differential. [Docket No. FDA–2016–D–2153]
based on the balance due. Payment by
We take the foreign facility differential credit card is available for balances less Use of Real-World Evidence to Support
($15,000) and multiply it by the number than $25,000. If the balance exceeds this Regulatory Decisionmaking for
of foreign facilities (688) to determine amount, only the ACH option is Medical Devices; Draft Guidance for
the total fees that will result from the available. Payments must be drawn on Industry and Food and Drug
foreign facility differential. As a result U.S. bank accounts as well as U.S. credit Administration Staff; Availability
of that calculation, the foreign fee cards.
differential will make up $10,320,000 of FDA has partnered with the U.S. AGENCY: Food and Drug Administration,
the total API fee revenue. Subtracting Department of the Treasury to utilize HHS.
the foreign facility differential fee Pay.gov, a Web-based payment ACTION: Notice of availability.
revenue ($10,320,000) from the total API application, for online electronic
facility target revenue ($45,221,000) payment. The Pay.gov feature is SUMMARY: The Food and Drug
results in a remaining balance of available on the FDA Web site after Administration (FDA or Agency) is
$34,901,000. To determine the domestic completing the Generic Drug User Fee announcing the availability of the draft
API facility fee, we divide the Cover Sheet and generating the user fee guidance entitled ‘‘Use of Real-World
$34,901,000 by the total number of ID number. Evidence to Support Regulatory
facilities (789) which gives us a Please include the user fee ID number Decisionmaking for Medical Devices.’’
domestic API facility fee of $44,234. The on your check, bank draft, or postal FDA is issuing this draft guidance to
sradovich on DSK3GMQ082PROD with NOTICES
foreign API facility fee is $15,000 more money order and make payable to the clarify how we evaluate real-world data
than the domestic API facility fee, or order of the Food and Drug (RWD) to determine whether it may be
$59,234. Administration. Your payment can be sufficiently relevant and reliable to
mailed to: Food and Drug generate the types of real-world
VIII. Fee Schedule for FY 2017
Administration, P.O. Box 979108, St. evidence that can be used in regulatory
The fee rates for FY 2017 are set out Louis, MO 63197–9000. If checks are to decisionmaking for medical devices.
in Table 4. be sent by a courier that requests a street This guidance also clarifies when an
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![49230 Federal Register / Vol. 81, No. 144 / Wednesday, July 27, 2016 / Notices
II. Significance of Guidance for informed consent) have been ADDRESSES: You may submit comments
This draft guidance is being issued approved under OMB control number as follows:
consistent with FDA’s good guidance 0910–0586; the collections of
Electronic Submissions
practices regulation (21 CFR 10.115). information in 21 CFR part 54 (financial
disclosure by clinical investigators) Submit electronic comments in the
The draft guidance, when finalized, will following way:
represent the current thinking of FDA have been approved under OMB control
number 0910–0396; the collections of • Federal eRulemaking Portal: http://
on ‘‘Use of Real-World Evidence to www.regulations.gov. Follow the
Support Regulatory Decisionmaking for information in 21 CFR part 56.115 (IRB
records) have been approved under instructions for submitting comments.
Medical Devices.’’ It does not establish Comments submitted electronically,
any rights for any person and is not OMB control number 0910–0130; and
the collections of information in 21 CFR including attachments, to http://
binding on FDA or the public. You can www.regulations.gov will be posted to
use an alternative approach if it satisfies parts 50 (informed consent) and 56
(IRBs) have been approved under OMB the docket unchanged. Because your
the requirements of the applicable comment will be made public, you are
statutes and regulations. control number 0910–0755. The
collections of information in the solely responsible for ensuring that your
III. Electronic Access guidance ‘‘Requests for Feedback on comment does not include any
Medical Device Submissions: The Pre- confidential information that you or a
Persons interested in obtaining a copy third party may not wish to be posted,
of the draft guidance may do so by Submission Program and Meetings with
Food and Drug Administration Staff’’ such as medical information, your or
downloading an electronic copy from anyone else’s Social Security number, or
the Internet. A search capability for all have been approved under OMB control
number 0910–0756. confidential business information, such
Center for Devices and Radiological as a manufacturing process. Please note
Health guidance documents is available Dated: July 22, 2016.
that if you include your name, contact
at http://www.fda.gov/MedicalDevices/ Leslie Kux, information, or other information that
DeviceRegulationandGuidance/ Associate Commissioner for Policy. identifies you in the body of your
GuidanceDocuments/default.htm. [FR Doc. 2016–17750 Filed 7–26–16; 8:45 am] comments, that information will be
Guidance documents are also available BILLING CODE 4164–01–P posted on http://www.regulations.gov.
at http://www.regulations.gov. Persons • If you want to submit a comment
unable to download an electronic copy with confidential information that you
of ‘‘Use of Real-World Evidence to DEPARTMENT OF HEALTH AND do not wish to be made available to the
Support Regulatory Decisionmaking for HUMAN SERVICES public, submit the comment as a
Medical Devices’’ may send an email written/paper submission and in the
request to CDRH-Guidance@fda.hhs.gov Food and Drug Administration manner detailed (see ‘‘Written/Paper
to receive an electronic copy of the Submissions’’ and ‘‘Instructions’’).
document. Please use the document [Docket No. FDA–2015–D–1439]
number 1500012 to identify the Written/Paper Submissions
guidance you are requesting. Adaptive Designs for Medical Device Submit written/paper submissions as
IV. Paperwork Reduction Act of 1995 Clinical Studies; Guidance for Industry follows:
and Food and Drug Administration • Mail/Hand delivery/Courier (for
This guidance refers to previously Staff; Availability written/paper submissions): Division of
approved collections of information Dockets Management (HFA–305), Food
found in FDA regulations and guidance. AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers
These collections of information are HHS. Lane, Rm. 1061, Rockville, MD 20852.
subject to review by the Office of ACTION: Notice of availability. • For written/paper comments
Management and Budget (OMB) under submitted to the Division of Dockets
the Paperwork Reduction Act of 1995 SUMMARY: The Food and Drug Management, FDA will post your
(44 U.S.C. 3501–3520). The collections Administration (FDA or Agency) is comment, as well as any attachments,
of information in 21 CFR part 807, announcing the availability of the except for information submitted,
subpart E have been approved under guidance entitled ‘‘Adaptive Designs for marked, and identified, as confidential,
OMB control number 0910–0120; the Medical Device Clinical Studies.’’ This if submitted as detailed in
collections of information in 21 CFR guidance provides sponsors and FDA ‘‘Instructions.’’
part 814, subparts A through E staff with guidance on how to plan and Instructions: All submissions received
(premarket approval) have been implement adaptive designs for clinical must include the Docket No. FDA–
approved under OMB control number studies when used in medical device 2015–D–1439 for ‘‘Adaptive Designs for
0910–0231; the collections of development programs. An adaptive Medical Device Clinical Studies.’’
information in 21 CFR part 814, subpart design for a medical device clinical Received comments will be placed in
H (humanitarian device exemption) study is defined as a clinical trial design the docket and, except for those
have been approved under OMB control that allows for prospectively planned submitted as ‘‘Confidential
number 0910–0332; the collections of modifications based on accumulating Submissions,’’ publicly viewable at
information in 21 CFR part 812 study data without undermining the http://www.regulations.gov or at the
(investigational device exemption) have trial’s integrity and validity. Adaptive Division of Dockets Management
been approved under OMB control designs, when properly implemented,
sradovich on DSK3GMQ082PROD with NOTICES
between 9 a.m. and 4 p.m., Monday
number 0910–0078; the collections of can reduce resource requirements and/ through Friday.
information in 21 CFR part 822 or increase the chance of study success. • Confidential Submissions—To
(postmarket surveillance) have been DATES: Submit either electronic or submit a comment with confidential
approved under OMB control number written comments on this guidance at information that you do not wish to be
0910–0449; the collections of any time. General comments on Agency made publicly available, submit your
information in 21 CFR part 50.23 guidance documents are welcome at any comments only as a written/paper
(exception from general requirements time. submission. You should submit two
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Document Created: 2018-02-08 08:02:38
Document Modified: 2018-02-08 08:02:38
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 25, 2016. | |
| Contact | Benjamin Eloff, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2254, Silver Spring, MD 20993-0002, 301-796-8528. | |
| FR Citation | 81 FR 49228 |
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