81 FR 78603 - Medical Device Reporting for Manufacturers; 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 216 (November 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 216 (November 8, 2016)
| Page Range | 78603-78605 | |
| FR Document | 2016-26933 |
[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)] [Notices] [Pages 78603-78605] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26933] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; 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) is announcing the availability of the guidance entitled ``Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff.'' This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions. 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 [[Page 78604]] 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-2013-D-0743 for ``Medical Device Reporting for Manufacturers''. 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 ``Medical Device Reporting for Manufacturers'' 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: Isaac Chang, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3114, Silver Spring, MD 20993-0002, 301-796-2789. SUPPLEMENTARY INFORMATION: I. Background Medical device reporting under section 519(a) of the Federal Food Drug, and Cosmetic Act (21 U.S.C. 360i(a)) provides a mechanism that allows FDA and device manufacturers, user facilities, and importer of medical devices to identify and monitor adverse events (deaths and serious injuries) and certain malfunctions involving your medical devices. The goal is to detect and correct problems in a timely manner. This guidance updates FDA's policy and clarifies FDA's interpretations of the regulatory requirements under part 803 (21 CFR part 803) and includes a section on common reporting errors. The draft of this guidance was made available in the Federal Register on July 9, 2013 (78 FR 41069), and the comment period closed October 7, 2013. FDA reviewed and considered all public comments received and revised the guidance as appropriate. This document supersedes the draft entitled, ``Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff,'' dated July 9, 2013, and the previous guidance on this topic, ``Medical Device Reporting for Manufacturers,'' issued March 1997. 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 medical device reporting. 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.regulations.gov. Persons unable to download an electronic copy of ``Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1828 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. 3501-3520). The collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485; the collections of information in part 803, regarding medical device reporting, have been approved under OMB control number 0910-0437; the collections of information in 21 CFR part 806, regarding corrections and removals, have been approved under OMB control number 0910-0359; the collections of information in 21 CFR part 807, subpart E, regarding premarket notification, [[Page 78605]] have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812, regarding investigational device exemptions, have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820, regarding quality system regulations, have been approved under OMB control number 0910-0073; the collections of information regarding MedWatch: The Food and Drug Administration Medical Products Reporting Program have been approved under OMB control number 0910-0291; and the collections of information regarding the Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)) have been approved under OMB control number 0910-0471. Dated: November 3, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26933 Filed 11-7-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Notices 78603
and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. all matters regarding the use of the
Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. PhUSE SDSP template.
• For written/paper comments FOR FURTHER INFORMATION CONTACT: II. Electronic Access
submitted to the Division of Dockets Crystal Allard, Center for Drug
Management, FDA will post your The PhUSE SDSP template is
Evaluation and Research, Food and
comment, as well as any attachments, available at: http://www.phusewiki.org/
Drug Administration, 10903 New
except for information submitted, wiki/images/e/ea/SDSP_Template.pdf.
Hampshire Ave., Bldg. 21, Rm. 1518,
marked and identified, as confidential, Silver Spring, MD 20993–0002, 301– Dated: November 2, 2016.
if submitted as detailed in 796–8856, crystal.allard@fda.hhs.gov. Leslie Kux,
‘‘Instructions.’’ Associate Commissioner for Policy.
Instructions: All submissions received SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–26913 Filed 11–7–16; 8:45 am]
must include the Docket No. FDA– I. Background BILLING CODE 4164–01–P
2016–N–3362 for ‘‘Intent to Review a
Study Data Standardization Plan FDA is a participating member of
Template.’’ Received comments will be PhUSE, an independent, non-profit
consortium of academic, regulatory, DEPARTMENT OF HEALTH AND
placed in the docket and, except for HUMAN SERVICES
those submitted as ‘‘Confidential non-profit, and private sector entities.
Submissions,’’ publicly viewable at PhUSE provides a global platform for Food and Drug Administration
http://www.regulations.gov or at the the discussion of topics encompassing
the work of biostatisticians, data [Docket No. FDA–2013–D–0743]
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday managers, statistical programmers, and
e-clinical information technology Medical Device Reporting for
through Friday. Manufacturers; Guidance for Industry
• Confidential Submissions—To professionals, with the mission of
providing an open, transparent, and and Food and Drug Administration
submit a comment with confidential Staff; Availability
information that you do not wish to be collaborative forum to address
made publicly available, submit your computational science issues. As part of AGENCY: Food and Drug Administration,
comments only as a written/paper this collaboration, PhUSE working HHS.
submission. You should submit two groups develop and periodically publish ACTION: Notice of availability.
copies total. One copy will include the proposals for enhancing the review and
information you claim to be confidential analysis of human and animal study SUMMARY: The Food and Drug
with a heading or cover note that states data submitted to regulatory agencies. Administration (FDA) is announcing the
‘‘THIS DOCUMENT CONTAINS You can learn more about PhUSE availability of the guidance entitled
CONFIDENTIAL INFORMATION.’’ The working groups at http://www.phuse.eu/ ‘‘Medical Device Reporting for
Agency will review this copy, including cs-working-groups.aspx. (FDA has Manufacturers; Guidance for Industry
the claimed confidential information, in verified the Web site addresses as of the and Food and Drug Administration
its consideration of comments. The date this document publishes in the Staff.’’ This guidance document is
second copy, which will have the Federal Register, but Web sites are intended to assist medical device
claimed confidential information subject to change over time.) manufacturers meet applicable reporting
redacted/blacked out, will be available In December 2014, FDA published the and recordkeeping requirements for
for public viewing and posted on http:// Study Data Technical Conformance certain device-related adverse events
www.regulations.gov. Submit both Guide (the ‘‘Guide,’’ available at http:// and malfunctions.
copies to the Division of Dockets www.fda.gov/ForIndustry/ DATES: Submit either electronic or
Management. If you do not wish your DataStandards/StudyDataStandards/ written comments on this guidance at
name and contact information to be default.htm), which contains technical any time. General comments on Agency
made publicly available, you can recommendations to sponsors for the guidance documents are welcome at any
provide this information on the cover submission of animal and human study time.
sheet and not in the body of your data and related information in a ADDRESSES: You may submit comments
comments and you must identify this standardized electronic format. In as follows:
information as ‘‘confidential.’’ Any section 2.1 of the Guide, FDA
information marked as ‘‘confidential’’ recommends that sponsors should Electronic Submissions
will not be disclosed except in include a plan (e.g., in the IND) Submit electronic comments in the
accordance with 21 CFR 10.20 and other describing the submission of following way:
applicable disclosure law. For more standardized study data to FDA. FDA’s • Federal eRulemaking Portal: http://
information about FDA’s posting of Study Data Standards Resources Web www.regulations.gov. Follow the
comments to public dockets, see 80 FR page provides recommendations for instructions for submitting comments.
56469, September 18, 2015, or access preparing an SDSP (http://www.fda.gov/ Comments submitted electronically,
the information at: http://www.fda.gov/ downloads/ForIndustry/DataStandards/ including attachments, to http://
regulatoryinformation/dockets/ StudyDataStandards/UCM447119.pdf). www.regulations.gov/ will be posted to
default.htm. FDA now intends to review the the docket unchanged. Because your
Docket: For access to the docket to PhUSE SDSP template, a deliverable of comment will be made public, you are
read background documents or the the working group effort described solely responsible for ensuring that your
mstockstill on DSK3G9T082PROD with NOTICES
electronic and written/paper comments previously in this document, with the comment does not include any
received, go to http:// potential result that FDA could confidential information that you or a
www.regulations.gov and insert the recommend the use of the template in third party may not wish to be posted,
docket number, found in brackets in the its current form, or in a modified form, such as medical information, your or
heading of this document, into the for use in the regulatory submission of anyone else’s Social Security number, or
‘‘Search’’ box and follow the prompts study data in conformance with the confidential business information, such
and/or go to the Division of Dockets Guide. FDA invites public comment on as a manufacturing process. Please note
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![Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Notices 78605
have been approved under OMB control DATES: Submit either electronic or information that you do not wish to be
number 0910–0120; the collections of written comments on Agency guidances made publicly available, submit your
information in 21 CFR part 812, at any time. comments only as a written/paper
regarding investigational device ADDRESSES: You may submit comments submission. You should submit two
exemptions, have been approved under as follows: copies total. One copy will include the
OMB control number 0910–0078; the information you claim to be confidential
collections of information in 21 CFR Electronic Submissions with a heading or cover note that states
part 814, subparts A through E, Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
regarding premarket approval, have following way: CONFIDENTIAL INFORMATION.’’ The
been approved under OMB control • Federal eRulemaking Portal: http:// Agency will review this copy, including
number 0910–0231; the collections of www.regulations.gov. Follow the the claimed confidential information, in
information in 21 CFR part 820, instructions for submitting comments. its consideration of comments. The
regarding quality system regulations, Comments submitted electronically, second copy, which will have the
have been approved under OMB control including attachments, to http:// claimed confidential information
number 0910–0073; the collections of www.regulations.gov will be posted to redacted/blacked out, will be available
information regarding MedWatch: The the docket unchanged. Because your for public viewing and posted on http://
Food and Drug Administration Medical comment will be made public, you are www.regulations.gov. Submit both
Products Reporting Program have been solely responsible for ensuring that your copies to the Division of Dockets
approved under OMB control number comment does not include any Management. If you do not wish your
0910–0291; and the collections of confidential information that you or a name and contact information to be
information regarding the Adverse third party may not wish to be posted, made publicly available, you can
Event Program for Medical Devices such as medical information, your or provide this information on the cover
(Medical Product Safety Network anyone else’s Social Security number, or sheet and not in the body of your
(MedSun)) have been approved under confidential business information, such comments and you must identify this
OMB control number 0910–0471. as a manufacturing process. Please note information as ‘‘confidential.’’ Any
that if you include your name, contact information marked as ‘‘confidential’’
Dated: November 3, 2016.
information, or other information that will not be disclosed except in
Leslie Kux, identifies you in the body of your accordance with 21 CFR 10.20 and other
Associate Commissioner for Policy. comments, that information will be applicable disclosure law. For more
[FR Doc. 2016–26933 Filed 11–7–16; 8:45 am] posted on http://www.regulations.gov. information about FDA’s posting of
BILLING CODE 4164–01–P • If you want to submit a comment comments to public dockets, see 80 FR
with confidential information that you 56469, September 18, 2015, or access
do not wish to be made available to the the information at: http://www.fda.gov/
DEPARTMENT OF HEALTH AND public, submit the comment as a regulatoryinformation/dockets/
HUMAN SERVICES written/paper submission and in the default.htm.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Food and Drug Administration Submissions’’ and ‘‘Instructions’’). read background documents or the
Written/Paper Submissions electronic and written/paper comments
[Docket No. FDA–2010–D–0075]
received, go to http://
Submit written/paper submissions as
Non-Inferiority Clinical Trials To www.regulations.gov and insert the
follows:
Establish Effectiveness; Guidance for • Mail/Hand delivery/Courier (for docket number, found in brackets in the
Industry; Availability written/paper submissions): Division of heading of this document, into the
Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
HHS. Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
ACTION: Notice of availability. • For written/paper comments 1061, Rockville, MD 20852.
submitted to the Division of Dockets Submit written requests for single
SUMMARY: The Food and Drug Management, FDA will post your copies of this guidance to the Division
Administration (FDA or Agency) is comment, as well as any attachments, of Drug Information, Center for Drug
announcing the availability of a except for information submitted, Evaluation and Research, Food and
guidance for industry entitled ‘‘Non- marked and identified, as confidential, Drug Administration, 10001 New
Inferiority Clinical Trials to Establish if submitted as detailed in Hampshire Ave., Hillandale Building,
Effectiveness.’’ This document provides ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993–
guidance to sponsors and applicants Instructions: All submissions received 0002 or the Office of Communication,
submitting investigational new drug must include the Docket No. FDA– Outreach and Development, Center for
applications (INDs), new drug 2010–D–0075 for ‘‘Non-Inferiority Biologics Evaluation and Research
applications (NDAs), biologics licensing Clinical Trials to Establish (CBER), Food and Drug Administration,
applications (BLAs), or supplemental Effectiveness; Guidance for Industry.’’ 10903 New Hampshire Ave., Bldg. 71,
applications on the appropriate use of Received comments will be placed in Rm. 3128, Silver Spring, MD 20993–
non-inferiority (NI) study designs to the docket and, except for those 0002. Send one self-addressed adhesive
provide evidence of the effectiveness of submitted as ‘‘Confidential label to assist that office in processing
mstockstill on DSK3G9T082PROD with NOTICES
a drug or biologic. The guidance gives Submissions,’’ publicly viewable at your requests. See the SUPPLEMENTARY
advice on when NI studies http://www.regulations.gov or at the INFORMATION section for electronic
demonstrating effectiveness of an Division of Dockets Management access to the guidance document.
investigational drug can provide between 9 a.m. and 4 p.m., Monday FOR FURTHER INFORMATION CONTACT:
interpretable results, how to choose the through Friday. Scott Goldie, Center for Drug Evaluation
NI margin, and how to test the NI • Confidential Submissions—To and Research, Food and Drug
hypothesis. submit a comment with confidential Administration, 10903 New Hampshire
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Document Created: 2018-02-14 08:23:42
Document Modified: 2018-02-14 08:23:42
| 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 | Isaac Chang, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3114, Silver Spring, MD 20993-0002, 301-796-2789. | |
| FR Citation | 81 FR 78603 |
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