81 FR 90365 - Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”); 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 240 (December 14, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 240 (December 14, 2016)
| Page Range | 90365-90367 | |
| FR Document | 2016-29989 |
[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)] [Notices] [Pages 90365-90367] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29989] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-4803] Public Notification of Emerging Postmarket Medical Device Signals (``Emerging Signals''); 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 guidance entitled ``Public Notification of Emerging Postmarket Medical Device Signals (`Emerging Signals').'' FDA is issuing this guidance to describe the Center for Devices and Radiological Health's (CDRH) policy for notifying the public about medical device ``emerging signals.'' This guidance describes the [[Page 90366]] factors CDRH intends to consider in deciding whether to notify the public about an emerging signal and the processes and timelines it intends to follow in issuing and updating the notification. Timely notification about those emerging signals based on the factors described in this guidance document is intended to provide health care providers, patients, and consumers with access to the most current information concerning the performance and potential benefits and risks of marketed medical devices so that they can make informed patient management decisions about their treatment and diagnostic options. 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 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-4803 for ``Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').'' 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 ``Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals')'' 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: Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527. SUPPLEMENTARY INFORMATION: I. Background All medical devices have benefits and risks. FDA weighs probable benefit to health from the use of the device against any probable risk of injury or illness from such use in determining the safety and effectiveness of a device.\1\ Once FDA has made its determination, health care providers, patients, and consumers must weigh these benefits and risks when making patient management decisions. However, not all information regarding benefits and risks for a given device may be known before the device reaches the market. New information about a device's safety and/or effectiveness, including unanticipated adverse events, may become available once the device is more widely distributed and used under real-world conditions and in broader patient populations than may have been studied in support of a marketing application. Also, subsequent changes made to the device, its manufacturing process, or supply chain might lead to new safety problems. --------------------------------------------------------------------------- \1\ See 21 U.S.C. 360c(a)(2) and 21 CFR 860.7. --------------------------------------------------------------------------- FDA is issuing this guidance to describe CDRH policy for notifying the public about medical device ``emerging signals.'' For the purposes of this guidance, an emerging signal is new information about a marketed medical device: (1) That supports a new causal association or a new aspect of a known association between a device and an adverse event or set of adverse events and (2) for which the Agency has conducted an initial evaluation and determined that the information has the potential to impact patient management decisions and/or the known benefit-risk profile of the device. Information that is [[Page 90367]] unconfirmed, unreliable, or lacks sufficient strength of evidence is not an emerging signal. This guidance describes the factors CDRH intends to consider in deciding whether to notify the public about emerging signals and the processes and timelines it intends to follow in issuing and updating the notification. Timely notification about those emerging signals based on the factors described in this guidance document is intended to provide health care providers, patients, and consumers with access to the most current information concerning the performance and potential benefits and risks of marketed medical devices so that they can make informed patient management decisions about their treatment and diagnostic options. In the Federal Register of December 31, 2015 (80 FR 81829), FDA announced the availability of the draft of this guidance. Interested persons were invited to comment by February 29, 2016. In the Federal Register of January 27, 2016 (81 FR 4632), FDA extended the comment period to March 29, 2016. FDA received and considered 21 sets of public comments and revised the guidance as appropriate. CDRH also intends to provide periodic public updates on the implementation of 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 ``Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').'' 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 ``Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals')'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500027 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, regarding labeling, have been approved under OMB control number 0910-0485 and the collections of information in 21 CFR part 803, regarding medical device reporting, have been approved under OMB control numbers 0910-0291, 0910-0437, and 0910-0471. Dated: December 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29989 Filed 12-13-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Notices 90365
using the travel cost rate for foreign for an onsite performance evaluation of Estimated fee
travel, because we anticipate that the the applicant (including travel and other Fee category rates for FY
vast majority of onsite assessments steps necessary for a fully supported 2017
made by FDA under this program will FTE to complete an onsite assessment),
Renewal application fee for
require foreign travel. In FY 2015, ORA and 45 person-hours to prepare a recognized accreditation
spent a total of $2,521,216 on 269 written report documenting the onsite body .................................. $18,855
foreign inspection trips related to FDA’s assessment. Initial application fee for cer-
CFSAN and CVM field activities FDA employees are likely to review tification body seeking di-
programs, which averaged a total of rect-accreditation from
applications and prepare reports from
$9,373 per foreign inspection trip. These FDA ................................... 35,100
their worksites, so we use the fully
trips averaged 3 weeks (or 120 paid Renewal application fee for
supported FTE hourly rate excluding directly-accredited certifi-
hours) per trip. Dividing $9,373 per trip
travel, $204/hour, to calculate the cation body ........................ 26,460
by 120 hours per trip results in a total
and an additional cost of $78 per paid portion of the user fee attributable to Annual fee for recognized
hour spent for foreign inspection travel those activities: $204/hour × (60 hours accreditation body ............. 1,579
+ 45 hours) = $21,420. FDA employees Annual fee for certification
costs in FY 2015. To adjust $78 for body directly-accredited by
inflationary increases in FY 2016 and will likely travel to foreign countries for
the onsite performance evaluations FDA ................................... 20,208
FY 2017, FDA must multiply it by the Annual fee for accredited
same inflation factor mentioned because most accreditation bodies are certification body ............... 1,974
previously in this document (1.036047), located in foreign countries. For this
which results in an estimated cost of portion of the fee we use the fully
V. How Must the Fee Be Paid?
$81 dollars per paid hour in addition to supported FTE hourly rate for work
requiring travel, $285/hour, to calculate Accreditation bodies seeking initial
$204 for a total of $285 per paid hour
($204 plus $81) for each direct hour of the portion of the user fee attributable recognition must submit the application
work requiring foreign inspection travel. to those activities: $285 × 48 hours (i.e., fee with the application.
FDA will use these rates in charging fees 2 fully supported FTEs × (2 travel days VI. What Are the Consequences of Not
in FY 2017 when travel is required for + 1 day onsite)) = $13,680. The Paying This Fee?
the third-party certification program. estimated average cost of the work FDA
performs in total for reviewing an initial The consequence of not paying this
application for recognition for an fee is outlined in § 1.725. If FDA does
TABLE 2—FSMA FEE SCHEDULE FOR not receive an application fee with an
FY 2017 accreditation body based on these
figures would be $21,420 + $13,680 = application for recognition, the
$35,100. Therefore the application fee application will be considered
Fee rates for
Fee category incomplete and FDA would not review
FY 2017 for accreditation bodies applying for
recognition in FY 2017 will be $35,100. the application.
Hourly rate without travel ..... $204 Dated: December 9, 2016.
Hourly rate if travel is re- IV. Estimated Fees for Accreditation Leslie Kux,
quired ................................
285 Bodies and Certification Bodies in Fee
Associate Commissioner for Policy.
Categories Not Applicable in FY 2017
III. Application Fee for Accreditation [FR Doc. 2016–30034 Filed 12–13–16; 8:45 am]
Bodies Applying for Recognition in the The third-party certification program BILLING CODE 4164–01–P
Third-Party Certification Program will also assess other application fees
Under Section 808(c)(8) of the FD&C and annual fees in future years of this
Act program. Section 1.705(a) also DEPARTMENT OF HEALTH AND
establishes application fees for HUMAN SERVICES
In FY 2017 (the first fiscal year in
which the program will operate), the recognized accreditation bodies
submitting renewal applications, Food and Drug Administration
only fee that will be collected by FDA
under section 808(c)(8) of the FD&C Act certification bodies applying for direct [Docket No. FDA–2015–D–4803]
is the initial application fee for accreditation, and certification bodies
applying for renewal of direct Public Notification of Emerging
accreditation bodies seeking
accreditation. Section 1.705(b) Postmarket Medical Device Signals
recognition. Section 1.705(a)(1)
establishes annual fees for recognized (‘‘Emerging Signals’’); Guidance for
establishes an application fee for
Industry and Food and Drug
accreditation bodies applying for initial accreditation bodies, certification bodies
directly accredited by FDA, and Administration Staff; Availability
recognition that represents the
estimated average cost of the work FDA certification bodies accredited by AGENCY: Food and Drug Administration,
performs in reviewing and evaluating recognized accreditation bodies. HHS.
initial applications for recognition of Although we will not be collecting ACTION: Notice of availability.
accreditation bodies. these other fees in FY 2017, for
The fee is based on the fully transparency and planning purposes, we SUMMARY: The Food and Drug
supported FTE hourly rates and have provided an estimate of what these Administration (FDA or Agency) is
estimates of the number of hours it fees could have been for FY 2017 based announcing the availability of the
would take FDA to perform relevant on the fully supported FTE hourly rates guidance entitled ‘‘Public Notification
sradovich on DSK3GMQ082PROD with NOTICES
activities. These estimates represent for FY 2017 and estimates of the number of Emerging Postmarket Medical Device
FDA’s current thinking, and as the of hours it would take FDA to perform Signals (‘Emerging Signals’).’’ FDA is
program evolves, FDA will reconsider relevant activities as outlined in the issuing this guidance to describe the
the estimated hours. We estimate that it Final Regulatory Impact Analysis for the Center for Devices and Radiological
would take, on average, 60 person-hours Third-Party Certification Regulation. Health’s (CDRH) policy for notifying the
to review an accreditation body’s Table 3 provides an overview of the public about medical device ‘‘emerging
submitted application, 48 person-hours estimated fees for other fee categories. signals.’’ This guidance describes the
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![Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Notices 90367
unconfirmed, unreliable, or lacks number 1500027 to identify the FOR FURTHER INFORMATION CONTACT:
sufficient strength of evidence is not an guidance you are requesting. Adam Wong, adam.wong@hhs.gov
emerging signal. (preferred), 202–720–2866.
IV. Paperwork Reduction Act of 1995
This guidance describes the factors SUPPLEMENTARY INFORMATION:
CDRH intends to consider in deciding This guidance refers to previously
approved collections of information Award Approving Official
whether to notify the public about
emerging signals and the processes and found in FDA regulations. These B. Vindell Washington, National
timelines it intends to follow in issuing collections of information are subject to Coordinator for Health Information
and updating the notification. Timely review by the Office of Management and Technology
notification about those emerging Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501– Subject of Challenge
signals based on the factors described in
this guidance document is intended to 3520). The collections of information in In 2011, the Office of the National
provide health care providers, patients, 21 CFR parts 801, regarding labeling, Coordinator for Health Information
and consumers with access to the most have been approved under OMB control Technology (ONC) collaborated with the
current information concerning the number 0910–0485 and the collections Federal Trade Commission (FTC) and
performance and potential benefits and of information in 21 CFR part 803, released a Model Privacy Notice (MPN)
risks of marketed medical devices so regarding medical device reporting, focused on personal health records
that they can make informed patient have been approved under OMB control (PHRs), which were the emerging
management decisions about their numbers 0910–0291, 0910–0437, and technology at the time (view 2011 PHR
treatment and diagnostic options. 0910–0471. MPN). The project’s goals were to
In the Federal Register of December increase consumers’ awareness of
Dated: December 9, 2016.
companies’ PHR data practices and
31, 2015 (80 FR 81829), FDA announced Leslie Kux, empower consumers by providing them
the availability of the draft of this Associate Commissioner for Policy. with an easy way to compare the data
guidance. Interested persons were [FR Doc. 2016–29989 Filed 12–13–16; 8:45 am] practices of two or more PHR
invited to comment by February 29, BILLING CODE 4164–01–P companies. In the last five years, the
2016. In the Federal Register of January
health information technology market
27, 2016 (81 FR 4632), FDA extended
has changed significantly and there is
the comment period to March 29, 2016. DEPARTMENT OF HEALTH AND now a larger variety of products such as
FDA received and considered 21 sets of HUMAN SERVICES mobile applications and wearable
public comments and revised the
devices that collect digital health data.
guidance as appropriate. CDRH also Announcement of Requirements and ONC recognized a need to update the
intends to provide periodic public Registration for ‘‘Privacy Policy MPN to make it applicable to a broad
updates on the implementation of this Snapshot Challenge’’ range of consumer health technologies
guidance. beyond PHRs. More and more
AGENCY: Office of the National
II. Significance of Guidance Coordinator for Health Information individuals are obtaining access to their
Technology, HHS. electronic health information and using
This guidance is being issued consumer health technology to manage
consistent with FDA’s good guidance ACTION: Notice.
this information. As retail products that
practices regulation (21 CFR 10.115). collect digital health data directly from
The guidance represents the current SUMMARY: The Model Privacy Notice
(MPN) is a voluntary, openly available consumers are used, such as exercise
thinking of FDA on ‘‘Public Notification trackers, it is increasingly important for
of Emerging Postmarket Medical Device resource designed to help health
technology developers who collect consumers to be aware of companies’
Signals (’Emerging Signals’).’’ It does privacy and security policies and
not establish any rights for any person digital health data clearly convey
information about their privacy and information sharing practices. Health
and is not binding on FDA or the public. technology developers can use the MPN
You can use an alternative approach if security policies to their users. Similar
to easily enter their information
it satisfies the requirements of the to a nutrition facts label, the MPN
practices and produce a notice to allow
applicable statutes and regulations. provides a snapshot of a product’s
consumers to quickly learn and
existing privacy practices, encouraging
III. Electronic Access understand privacy policies, compare
transparency and helping consumers
company policies, and make informed
Persons interested in obtaining a copy make informed choices when selecting
decisions. Many consumer health
of the guidance may do so by products. The MPN does not mandate
technologies are offered by
downloading an electronic copy from specific policies or substitute for more
organizations that are not subject to the
the Internet. A search capability for all comprehensive or detailed privacy
Health Insurance Portability and
Center for Devices and Radiological policies. The Privacy Policy Snapshot
Accountability Act (HIPAA) privacy and
Health guidance documents is available Challenge is a call for designers, security standards. This is detailed in
at http://www.fda.gov/MedicalDevices/ developers, and health data privacy the HHS report, Examining Oversight of
DeviceRegulationandGuidance/ experts to create an online MPN the Privacy & Security of Health Data
GuidanceDocuments/default.htm. generator. The statutory authority for Collected by Entities Not Regulated by
Guidance documents are also available this Challenge is Section 105 of the HIPAA, released in July 2016 by ONC’s
at http://www.regulations.gov. Persons America COMPETES Reauthorization
sradovich on DSK3GMQ082PROD with NOTICES
Office of the Chief Privacy Officer with
unable to download an electronic copy Act of 2010 (Pub. L. 111–358). the cooperation of the HHS Office for
of ‘‘Public Notification of Emerging DATES: Civil Rights (OCR) and the FTC.
Postmarket Medical Device Signals • Submission period begins: December The Privacy Policy Snapshot
(’Emerging Signals’)’’ may send an email 13, 2016 Challenge leverages updated content
request to CDRH-Guidance@fda.hhs.gov • Submission period ends: April 10, developed recently by ONC, with
to receive an electronic copy of the 2017 feedback from OCR, FTC, and other
document. Please use the document • Winners announced: May-June, 2017 private and public stakeholders. The
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Document Created: 2016-12-14 00:48:38
Document Modified: 2016-12-14 00:48:38
| 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 | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| Contact | Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527. | |
| FR Citation | 81 FR 90365 |
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