82 FR 4356 - Factors To Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions; Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 9 (January 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 9 (January 13, 2017)
| Page Range | 4356-4358 | |
| FR Document | 2017-00604 |
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)] [Notices] [Pages 4356-4358] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00604] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-1777] Factors To Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions; Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, 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 guidance entitled ``Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions.'' The purpose of this guidance is to provide greater clarity for FDA staff and Investigational Device Exemptions (IDE) application sponsors and sponsor-investigators regarding the principal factors that the Agency considers when assessing the benefits and risks of IDE applications for human clinical study. The guidance also characterizes benefits in the context of investigational research, which includes direct benefits to the subjects and benefits to others. 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: 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 [[Page 4357]] 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-2015-D-1777 for ``Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions.'' 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 guidance document entitled ``Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions'' 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 or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Karen Ulisney, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1545, Silver Spring, MD 20993-0002, 301-796-5513; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background A primary goal of this guidance is to clarify the factors that FDA considers when assessing risks and anticipated benefits for IDE studies, and how uncertainty may be offset by a variety of risk mitigation measures that can ensure appropriate patient and participant protections in investigational research settings. At earlier stages of device development, FDA considers appropriate mitigation measures for anticipated possible risks and unanticipated risks, whereas in later stages, risk mitigation focuses increasingly on the most probable risks. Another important goal of this guidance is to characterize benefits in the context of investigational research, which includes direct benefits to the subjects and benefits to others (to the extent there are indirect benefits to subjects or reflect the importance of knowledge to be gained). As with the benefit-risk framework for evaluating marketing applications, FDA assessment of benefits and risks for an IDE application takes into account the contextual setting in which the study is being proposed, including, but not limited to, the characterization of the disease or condition being treated or diagnosed, the availability of alternative treatments or diagnostics, and the risks associated with them. When available, information characterizing subject tolerance for risk and perspective on benefit may provide useful context during this assessment. In the Federal Register on June 18, 2015 (80 FR 34909), FDA announced the availability of the draft guidance and interested parties were requested to comment by September 16, 2015. FDA has considered all of the public comments received prior to finalizing this guidance. II. 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 FDA on ``Factors to Consider When Making Benefit- Risk Determinations for Medical Device Investigational Device Exemptions.'' 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 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.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryinformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to download an electronic copy of ``Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1783 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. 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- [[Page 4358]] 3520). The collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR 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 56.115 (Institutional Review Board records) have been approved under OMB control number 0910- 0130; and the collections of information in 21 CFR part 50, subpart B (Informed Consent of Human Subjects) and part 56 (Institutional Review Boards) have been approved under OMB control number 0910-0755. Dated: January 9, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-00604 Filed 1-12-17; 8:45 am] BILLING CODE 4164-01-P
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related deaths, serious injuries, and notification and review process. FDA’s risk managers working in medical
malfunctions to FDA; to require user regulations governing application for facilities. FDA will use the information
facilities to report device-related deaths Agency approval to market a new drug gathered from these surveys to quickly
directly to FDA and to manufacturers; (21 CFR part 314) and regulations obtain vital information about medical
and to report serious injuries to the governing biological products (21 CFR product risks and interventions to
manufacturer. Section 522 of the FD&C part 600) implement these statutory reduce risks so the Agency may take
Act (21 U.S.C. 360l) authorizes FDA to provisions. Currently, FDA monitors appropriate public health or regulatory
require manufacturers to conduct medical product related postmarket action including dissemination of this
postmarket surveillance of medical adverse events via both the mandatory information as necessary and
devices. Section 705(b) of the FD&C Act and voluntary MedWatch reporting appropriate.
(21 U.S.C. 375(b)) authorizes FDA to systems using FDA Forms 3500 and
FDA projects 6 emergency risk related
collect and disseminate information 3500A (OMB control number 0910–
surveys per year with a sample of
regarding medical products or cosmetics 0291) and the vaccine adverse event
in situations involving imminent danger between 50 and 10,000 respondents per
reporting system.
to health or gross deception of the FDA is seeking OMB clearance to survey. FDA also projects a response
consumer. Section 903(d)(2) of the collect vital information via a series of time of 0.5 hour per response. These
FD&C Act (21 U.S.C. 393(d)(2)) rapid response surveys. Participation in estimates are based on the maximum
authorizes the Commissioner of Food these surveys will be voluntary. This sample size per questionnaire that FDA
and Drugs to implement general powers request covers rapid response surveys may be able to obtain by working with
(including conducting research) to carry for community based health care health care professional organizations.
out effectively the mission of FDA. professionals, general type medical The annual number of surveys was
These sections of the FD&C Act enable facilities, specialized medical facilities determined by the maximum number of
FDA to enhance consumer protection (those known for cardiac surgery, surveys per year FDA has ever
from risks associated with medical obstetrics/gynecology services, pediatric conducted under this collection.
products usage that are not foreseen or services, etc.), other health care FDA estimates the burden of this
apparent during the premarket professionals, patients, consumers, and collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
FDA Rapid Response Survey .............................................. 10,000 6 60,000 0.5 30,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 9, 2017. Investigational Device Exemptions.’’ solely responsible for ensuring that your
Leslie Kux, The purpose of this guidance is to comment does not include any
Associate Commissioner for Policy. provide greater clarity for FDA staff and confidential information that you or a
[FR Doc. 2017–00632 Filed 1–12–17; 8:45 am] Investigational Device Exemptions (IDE) third party may not wish to be posted,
BILLING CODE 4164–01–P
application sponsors and sponsor- such as medical information, your or
investigators regarding the principal anyone else’s Social Security number, or
factors that the Agency considers when confidential business information, such
DEPARTMENT OF HEALTH AND assessing the benefits and risks of IDE as a manufacturing process. Please note
HUMAN SERVICES applications for human clinical study. that if you include your name, contact
The guidance also characterizes benefits information, or other information that
Food and Drug Administration in the context of investigational identifies you in the body of your
research, which includes direct benefits comments, that information will be
[Docket No. FDA–2015–D–1777] to the subjects and benefits to others. posted on http://www.regulations.gov.
DATES: Submit either electronic or • If you want to submit a comment
Factors To Consider When Making with confidential information that you
written comments on this guidance at
Benefit-Risk Determinations for do not wish to be made available to the
any time. General comments on Agency
Medical Device Investigational Device public, submit the comment as a
guidance documents are welcome at any
Exemptions; Guidance for written/paper submission and in the
time.
Investigational Device Exemption manner detailed (see ‘‘Written/Paper
Sponsors, Sponsor-Investigators, and ADDRESSES: You may submit comments
as follows: Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration Staff;
Availability Electronic Submissions Written/Paper Submissions
AGENCY: Food and Drug Administration, Submit electronic comments in the Submit written/paper submissions as
HHS. following way: follows:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ACTION: Notice of availability. • Federal eRulemaking Portal: http:// • Mail/Hand delivery/Courier (for
www.regulations.gov. Follow the written/paper submissions): Division of
SUMMARY: The Food and Drug instructions for submitting comments. Dockets Management (HFA–305), Food
Administration (FDA or Agency) is Comments submitted electronically, and Drug Administration, 5630 Fishers
announcing the availability of the including attachments, to http:// Lane, Rm. 1061, Rockville, MD 20852.
guidance entitled ‘‘Factors to Consider www.regulations.gov will be posted to • For written/paper comments
When Making Benefit-Risk the docket unchanged. Because your submitted to the Division of Dockets
Determinations for Medical Device comment will be made public, you are Management, FDA will post your
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![4358 Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
3520). The collections of information in considers your comment on this draft Division of Dockets Management
21 CFR part 812 have been approved guidance before it begins work on the between 9 a.m. and 4 p.m., Monday
under OMB control number 0910–0078; final version of the guidance, submit through Friday.
the collections of information in 21 CFR either electronic or written comments • Confidential Submissions—To
50.23 (Exception from general on the draft guidance by March 14, submit a comment with confidential
requirements for informed consent) 2017. information that you do not wish to be
have been approved under OMB control made publicly available, submit your
ADDRESSES: You may submit comments
number 0910–0586; the collections of comments only as a written/paper
as follows: submission. You should submit two
information in 21 CFR 56.115
(Institutional Review Board records) Electronic Submissions copies total. One copy will include the
have been approved under OMB control information you claim to be confidential
Submit electronic comments in the
number 0910–0130; and the collections with a heading or cover note that states
following way:
of information in 21 CFR part 50, ‘‘THIS DOCUMENT CONTAINS
• Federal eRulemaking Portal:
subpart B (Informed Consent of Human CONFIDENTIAL INFORMATION.’’ The
https://www.regulations.gov. Follow the
Subjects) and part 56 (Institutional Agency will review this copy, including
instructions for submitting comments.
Review Boards) have been approved the claimed confidential information, in
Comments submitted electronically,
under OMB control number 0910–0755. its consideration of comments. The
including attachments, to https://
second copy, which will have the
Dated: January 9, 2017. www.regulations.gov will be posted to claimed confidential information
Leslie Kux, the docket unchanged. Because your redacted/blacked out, will be available
Associate Commissioner for Policy. comment will be made public, you are for public viewing and posted on
[FR Doc. 2017–00604 Filed 1–12–17; 8:45 am] solely responsible for ensuring that your https://www.regulations.gov. Submit
BILLING CODE 4164–01–P
comment does not include any both copies to the Division of Dockets
confidential information that you or a Management. If you do not wish your
third party may not wish to be posted, name and contact information to be
DEPARTMENT OF HEALTH AND such as medical information, your or made publicly available, you can
HUMAN SERVICES anyone else’s Social Security number, or provide this information on the cover
confidential business information, such sheet and not in the body of your
Food and Drug Administration as a manufacturing process. Please note comments and you must identify this
that if you include your name, contact information as ‘‘confidential.’’ Any
[Docket No. FDA–2014–D–1525]
information, or other information that information marked as ‘‘confidential’’
Mixing, Diluting, or Repackaging identifies you in the body of your will not be disclosed except in
Biological Products Outside the Scope comments, that information will be accordance with 21 CFR 10.20 and other
of an Approved Biologics License posted on https://www.regulations.gov. applicable disclosure law. For more
Application; Revised Draft Guidance • If you want to submit a comment information about FDA’s posting of
For Industry; Availability with confidential information that you comments to public dockets, see 80 FR
do not wish to be made available to the 56469, September 18, 2015, or access
ACTION: Notice. public, submit the comment as a the information at: http://www.fda.gov/
written/paper submission and in the regulatoryinformation/dockets/
SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper default.htm.
Administration (FDA or the Agency) is Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
announcing the availability of a revised read background documents or the
draft guidance for industry entitled Written/Paper Submissions
electronic and written/paper comments
‘‘Mixing, Diluting, or Repackaging Submit written/paper submissions as received, go to https://
Biological Products Outside the Scope follows: www.regulations.gov and insert the
of an Approved Biologics License • Mail/Hand delivery/Courier (for docket number, found in brackets in the
Application.’’ This revised draft written/paper submissions): Division of heading of this document, into the
guidance describes the conditions under Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
which FDA does not intend to take and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
action against a State-licensed Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
pharmacy, a Federal facility, or an • For written/paper comments 1061, Rockville, MD 20852.
outsourcing facility that mixes, dilutes, submitted to the Division of Dockets Submit written requests for single
or repackages certain biological Management, FDA will post your copies of the draft guidance to the
products outside the scope of an comment, as well as any attachments, Division of Drug Information, Center for
approved biologics license application except for information submitted, Drug Evaluation and Research, Food
(BLA). It also describes the conditions marked and identified, as confidential, and Drug Administration, 10001 New
under which FDA does not intend to if submitted as detailed in Hampshire Ave., Hillandale Building,
take action when a State-licensed ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993–
pharmacy, a Federal facility, an Instructions: All submissions received 0002; or the Office of Communication,
outsourcing facility, or a physician must include the Docket No. FDA– Outreach and Development, Center for
prepares prescription sets of allergenic 2014–D–1525 for ‘‘Mixing, Diluting, or Biologics Evaluation and Research
asabaliauskas on DSK3SPTVN1PROD with NOTICES
extracts for subcutaneous Repackaging Biological Products (CBER), Food and Drug Administration,
immunotherapy. This revised draft Outside the Scope of an Approved 10903 New Hampshire Avenue, Bldg.
guidance for industry replaces the draft Biologics License Application.’’ 71, Rm. 3128, Silver Spring, MD 20993–
guidance for industry of the same title Received comments will be placed in 0002. Send one self-addressed adhesive
issued in February 2015. the docket and, except for those label to assist that office in processing
DATES: Although you can comment on submitted as ‘‘Confidential your requests. See the SUPPLEMENTARY
any guidance at any time (see 21 CFR Submissions,’’ publicly viewable at INFORMATION section for electronic
10.115(g)(5)), to ensure that the Agency https://www.regulations.gov or at the access to the draft guidance document.
VerDate Sep<11>2014 19:06 Jan 12, 2017 Jkt 241001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\13JAN1.SGM 13JAN1](https://thefederalregister.org/doc/82_FR_4365/page/3.svg)
Document Created: 2017-01-13 02:45:20
Document Modified: 2017-01-13 02:45:20
| 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 this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| Contact | Karen Ulisney, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1545, Silver Spring, MD 20993-0002, 301-796-5513; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. | |
| FR Citation | 82 FR 4356 |
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