Center for Devices and Radiological Health Premarket Approval Application Critical to Quality Pilot Program, 42815-42818 [2017-19258]
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Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices
unauthorized access to sensitive
customer information, issues of
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notice during the course of an
examination, a copy of a SAR, or other
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Also, a federal employee is prohibited
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Board of Governors of the Federal Reserve
System, September 6, 2017.
Ann E. Misback,
Secretary of the Board.
[FR Doc. 2017–19217 Filed 9–11–17; 8:45 am]
BILLING CODE 6210–01–P
Board of Governors of the Federal Reserve
System, September 6, 2017.
Yao-Chin Chao,
Assistant Secretary of the Board.
FEDERAL RESERVE SYSTEM
pmangrum on DSK3GDR082PROD with NOTICES1
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
[FR Doc. 2017–19211 Filed 9–11–17; 8:45 am]
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than October 5,
2017.
A. Federal Reserve Bank of Kansas
City (Dennis Denney, Assistant Vice
President) 1 Memorial Drive, Kansas
City, Missouri 64198–0001:
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1. Central Bancshares, Inc. to acquire,
through its newly formed subsidiaries,
CBI Midco, Inc. and CBI Merger Sub,
Inc., all of Cambridge, Nebraska, up to
100 percent of the voting shares of
Republic Corporation, and thereby
indirectly acquire United Republic
Bank, both of Omaha, Nebraska.
In connection with this application
CBI Midco, Inc. and CBI Merger Sub,
Inc., have applied to become bank
holding companies.
B. Federal Reserve Bank of San
Francisco (Gerald C. Tsai, Director,
Applications and Enforcement) 101
Market Street, San Francisco, California
94105–1579:
1. Pacific Premier Bancorp, Inc.; to
acquire 100 percent of Plaza Bancorp,
and thereby indirectly acquire Plaza
Bank, all of Irvine, California.
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4765]
Center for Devices and Radiological
Health Premarket Approval Application
Critical to Quality Pilot Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency or we)
Center for Devices and Radiological
Health (CDRH or Center), Office of
Compliance (OC) and Office of In Vitro
Diagnostics and Radiological Health
(OIR) is announcing its Premarket
Approval Application Critical to Quality
(PMA CtQ) pilot program. Participation
in the PMA CtQ pilot program is
voluntary and the program aims to
evaluate device design and
manufacturing process quality
information early on to assist FDA in its
review of the PMA manufacturing
section and post-approval inspections.
This voluntary pilot program is part of
the FDA’s ongoing Case for Quality
effort to apply innovative strategies that
promote medical device quality and is
a joint effort between the FDA’s CDRH
and Office of Regulatory Affairs (ORA).
The pilot program is intended to
provide qualifying PMA applicants with
the option to engage FDA on
SUMMARY:
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development of CtQ controls for their
device and forego the standard PMA
preapproval inspection. FDA would in
turn, focus on the PMA applicant’s
implementation of the CtQ controls
during a postmarket inspection.
DATES: FDA is seeking participation in
the voluntary PMA CtQ pilot program
starting from September 29, 2017. See
the ‘‘Participation’’ section for
instructions on how to submit a request
to participate. This pilot program will
run from September 29, 2017, to
December 31, 2018. The voluntary PMA
CtQ pilot program will accept the first
nine participants with submissions that
meet the acceptance criteria.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
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Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices
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2017–N–4765 for ‘‘Center for Devices
and Radiological Health Premarket
Approval Application Critical to Quality
Pilot Program.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Bleta Vuniqi, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3463, Silver Spring,
MD 20993, 301–796–5497,
Bleta.Vuniqi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
CDRH believes that proactive
engagement with PMA applicants and a
focused inspectional approach will
promote quality in device design and
manufacturing. CDRH plans to initiate
the voluntary PMA CtQ pilot program
focusing on activities critical to product
and process quality starting September
29, 2017. The Center intends to work
collaboratively with PMA applicants
identified to participate in the PMA CtQ
pilot program to define characteristics of
the PMA device that are critical to
product quality and how these
characteristics are controlled in design
and manufacturing prior to the
postmarket inspection. PMA applicants
can expect discussions during the
inspection to relate to those factors most
likely to impact device quality by
working with FDA, before PMA
approval, on defining activities critical
to product and process quality.
Improvements in overall device quality
may reduce device failures and recalls,
and translate into more efficient
utilization of resources for CDRH, ORA,
and the device industry. Previously,
CDRH’s OC completed the implantable
devices containing batteries Critical to
Quality Inspection pilot which
established a collaborative framework
for determining specific operations,
design considerations, and controls that
most impact the quality and safety of
these devices (Ref. 1). Post-inspection
feedback from ORA and CDRH’s OC
indicated that FDA can improve its
approach for medical device inspections
by focusing on areas critical to quality
of the device, which in turn will change
the compliance focus to influence better
device quality. In addition, feedback
received from industry participants
indicated that many of the risks for
devices reside in product and process
design and post-production activities.
Whether firms are appropriate
candidates for participation in this
voluntary PMA CtQ pilot program is
determined based on the factors listed
in Section A. Participation Criteria.
Upon applicant’s pre-PMA qsubmission meeting request, FDA will
identify appropriate candidates to
participate in this voluntary pilot
program. Due to resource constraints,
we intend to limit this voluntary pilot
program to a maximum of nine
participants. FDA intends to work with
each participating applicant to identify
characteristics of its device and its
manufacture that are critical to its
quality, which may include specific
device features or quality control
practices. The identified CtQ
characteristics and controls will help
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focus FDA’s post-approval inspectional
approach.
The aim of the voluntary PMA CtQ
pilot program is to have the applicant
discuss device design and
manufacturing process quality
information with FDA early on to assist
FDA in its review of the PMA
manufacturing section and postapproval inspections. The goal of this
voluntary pilot program is to streamline
the premarket approval process while
assuring that a firm’s quality system
includes rigorous controls for features
and characteristics considered critical to
the safety and effectiveness of the
device. FDA believes that focusing on
these activities may also lead to fewer
device failures, a decrease in device
recalls, and improved device innovation
and efficiencies. For participants in the
voluntary PMA CtQ pilot program, FDA
intends to forego conducting a
preapproval inspection, which it would
usually conduct, and instead conduct a
more focused post-approval inspection.
That post-approval inspection would
focus on the design, manufacturing, and
quality assurance practices identified by
the applicant in its PMA. In addition,
this voluntary pilot program is part of
the FDA’s ongoing Case for Quality
effort to apply innovative strategies that
promote medical device quality instead
of focusing only on compliance with the
Quality System regulation (Ref. 2). This
voluntary PMA CtQ pilot program does
not represent a new requirement;
instead, it is an opportunity to promote
quality in device manufacturing, timely
review of the PMA manufacturing
section and more effective use of
inspectional resources, and an enhanced
opportunity to engage with firms
regarding device quality prior to
marketing of the device. This voluntary
PMA CtQ pilot program augments the
FDA’s traditional Quality System
Inspection Technique (QSIT)
inspectional approach, and does not
replace it (Ref. 3).
Combination products, products
regulated by the Center for Biologics
Evaluation and Research, and
companion diagnostic In Vitro
Diagnostic devices that require
coordination with the Center for Drug
Evaluation and Research are not within
the scope of this voluntary PMA CtQ
pilot program.
A. Participation Criteria
Firms that are appropriate to
participate in this voluntary PMA CtQ
pilot program are those firms submitting
an original PMA who follow the
procedures set out in Section B and who
also:
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1. Submit a request for a pre-PMA qsubmission meeting, and
a. Provide the recommended
information identified in the guidance
document, ‘‘Requests for Feedback on
Medical Device Submissions: The PreSubmission Program and Meetings with
Food and Drug Administration Staff’’
dated February 18, 2014 (Ref. 4), along
with a statement of interest for
participation in this voluntary PMA CtQ
pilot program in the applicant’s cover
letter.
b. Provide a list of PMA-related
facilities responsible for the
manufacture, processing, packing, or
installation with the applicant’s prePMA q-submission submission package.
c. If available, submit a draft list of
critical characteristics for the device
which is the subject of the PMA
application.
2. As part of the PMA application,
include the proposed list of critical
characteristics as well as their
associated controls for the device which
is the subject of the PMA. The list
should include characteristics where
failure in meeting the characteristic
would have a reasonable likelihood or a
remote likelihood of causing a death or
serious injury.
3. Have their PMA application
accepted and filed for review by FDA
(Ref. 5).
4. Have not had Quality System
deficiencies identified in FDA’s review
of the manufacturing section of the
applicant’s PMA (Ref. 6).
5. Have had an FDA inspection of the
PMA-related facilities conducted at least
once within the last 5 years.
6. An FDA inspection of the PMArelated facilities has not been classified
as Official Action Indicated or been
subject to a judicial action (e.g., seizure
or injunction, including consent
decrees) within the last 5 years (Ref. 7).
B. Procedures
Postmarket inspections under this
proposed voluntary PMA CtQ pilot
program will be conducted in
accordance with FDA’s general
establishment inspection authority in
section 704(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 374(a)).
FDA intends for the investigator to
follow the current medical device
inspection model as outlined in the
2017 FDA Investigations Operations
Manual (IOM) Chapter 5 and FDA
Compliance Program 7383.001 ‘‘Medical
Device Premarket Approval and
Postmarket Inspections’’ dated March 5,
2012, with the following exceptions: (1)
The inspection is conducted in the
postmarket setting and (2) the
postmarket inspection includes an
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evaluation of critical control measures
for the production of the device are
implemented (Ref. 8–10). Section 5.1.2
of the IOM provides the inspection may
be directed for ‘‘obtaining specific
information on new technologies, good
commercial practices, or data for
establishing food standards or other
regulations.’’
Additionally, FDA intends on
soliciting feedback from ORA, industry
participants, and CDRH’s OC/OIR staff
during the voluntary PMA CtQ pilot
program. Feedback from participants
will be gathered through meetings and
questions proposed in Appendices A
and B (Ref. 11).
The following captures FDA’s
expected process for the voluntary PMA
CtQ pilot program:
1. A firm submits a pre-PMA qsubmission meeting request at least 75–
90 days in advance of submission of the
PMA application following the
recommendations outlined in the
guidance document ‘‘Requests for
Feedback on Medical Device
Submissions: The Pre-Submission
Program and Meetings with Food and
Drug Administration Staff’’ (Ref. 4)
dated February 18, 2014. Additional
expectations, include:
a. Providing a statement in the prePMA q-submission to support being
considered for participation in the
voluntary PMA CtQ pilot program.
b. Providing a list of PMA-related
facilities responsible for the
manufacture, processing, packing, or
installation for the device which is the
subject of the PMA as part of the
applicant’s pre-PMA q-submission
package.
c. If available, submitting a draft list
of critical characteristics for the device
which is the subject of the PMA
application.
2. During the pre-PMA q-submission
meeting, FDA clearly communicates the
voluntary PMA CtQ pilot program
expectations and discusses and provides
the applicant’s proposed draft list of
critical characteristics for the PMA
device and provide feedback.
3. Once a firm has expressed interest
in participating in the voluntary PMA
CtQ pilot program, CDRH determines
whether:
a. all PMA-related facilities have been
inspected within the last 5 years, and
b. all of the inspections of the PMArelated facilities have not been classified
as Official Action Indicated and have
not been subject to a judicial action
(e.g., a seizure or injunction action,
including a consent decree) within the
last 5 years.
4. The PMA application:
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a. Is accepted and filed for review by
FDA.
b. Includes as part of the
manufacturing section the proposed list
of device critical characteristics as well
as their associated controls, which may
include certain design, manufacturing,
or quality assurance practices. The list
of critical characteristics identified in
4(b) is based on risk to the patient or
user, including whether failure in
meeting the characteristic can have a
reasonable likelihood or a remote
likelihood of causing a death or serious
injury.
c. Is accompanied by a streamlined
process validation report to CDRH OC or
OIR no later than day 45 within the
PMA application process.
5. CDRH OC/OIR completes the
following during review of the PMA
application:
a. Checks the CtQ information for
clarity, completeness, and relevance to
the Quality System regulation within
days 1–45, with the goal to have the list
of device critical characteristics as well
as their associated controls finalized by
day 60 of the 180-day clock.
b. Reviews the manufacturing section
of the PMA application within the first
30 days of the 180-day clock. If Quality
System deficiencies are identified
during this review, then the PMA
application would no longer be
appropriate for inclusion in this
voluntary PMA CtQ pilot program. The
reviewer would follow the current
established procedures and place the
PMA application on ‘‘hold’’ pending
correction of the deficiencies.
c. Reviews the validation report
identified in section B.4(c) within 30
calendar days of receipt. Any concerns
raised by the validation report review
may result in the issuance of a
deficiency letter that will place the PMA
on ‘‘hold’’ pending Good Manufacturing
Practices corrections.
d. Provides an inspectional
assignment to the investigator and
makes necessary technical expertise
available to the ORA. The critical
characteristics and controls will help
guide the investigator and appropriately
focus their activities during the
postmarket inspection. In addition,
CDRH intends to include CtQ and
control information in an inspectional
assignment and contact the
investigator(s) to discuss critical control
measures and expectations prior to the
inspection.
6. Following an approval decision,
FDA conducts the postmarket
inspection in accordance with the 2017
FDA IOM, Compliance Program
7382.845, and Compliance Program
7383.001 (Ref. 8–10) utilizing elements
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of QSIT, and informed by the PMA CtQ
information developed jointly by FDA
and the PMA applicant.
7. Following completion of the
inspection, participating FDA Offices
and applicants provide the information/
data needed to assess the voluntary
PMA CtQ pilot program’s impact on
resource utilization and quality focus,
utilizing the evaluation forms provided
in Appendices A and B (Ref. 11).
During this voluntary PMA CtQ pilot
program, CDRH staff intends to be
available to answer questions or
concerns that may arise. The voluntary
PMA CtQ pilot program participants
will be asked to comment on and
discuss their experiences with the PMA
CtQ pilot submission process.
Comments and discussions may assist
FDA in determining whether the goals
of this voluntary PMA CtQ pilot
program goal are clearly communicated
and attainable.
II. Duration of the Premarket Approval
Application Critical to Quality Pilot
Program
FDA intends to accept requests for
participation in the voluntary PMA CtQ
pilot program from September 29, 2017,
to December 31, 2018, or until such time
as when a total of nine PMAs have been
enrolled.
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III. Paperwork Reduction Act of 1995
This notice 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 part 814, subparts A through E
have been approved under OMB control
number 0910–0231; the collections of
information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073; and the collections
of information in ‘‘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.
IV. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES),
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov. (FDA has verified
the Web site addresses, but we are not
responsible for any subsequent changes
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to the Web sites after this document
publishes in the Federal Register.)
1. Implantable Devices that Contain Batteries
Critical to Quality Inspection Pilot.
Available at https://www.fda.gov/
downloads/MedicalDevices/
DeviceRegulationandGuidance/
MedicalDeviceQualityandCompliance/
UCM469128.pdf.
2. FDA’s Case for Quality, available at https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
MedicalDeviceQualityandCompliance/
ucm378185.htm.
3. FDA’s Guide to Inspections of Quality
Systems, Quality System Inspection
Technique, available at https://
www.fda.gov/ICECI/Inspections/
InspectionGuides/ucm074883.htm.
4. FDA Guidance for Industry and FDA Staff
‘‘Requests for Feedback on Medical
Device Submissions: The PreSubmission Program and Meetings with
Food and Drug Administration Staff’’
dated February 18, 2014. Available at
https://www.fda.gov/ucm/groups/fdagovpublic/@fdagov-meddev-gen/documents/
document/ucm311176.pdf.
5. FDA’s Guidance for Industry and FDA
Staff: Acceptance and Filing Reviews for
Premarket Approval Applications
(PMAs) at https://www.fda.gov/ucm/
groups/fdagov-public/@fdagov-meddevgen/documents/document/
ucm313368.pdf.
6. FDA’s Guidance for Industry and FDA
Staff: Quality System Information for
Certain Premarket Application Reviews,
available at https://www.fda.gov/
medicaldevices/
deviceregulationandguidance/
guidancedocuments/ucm070897.htm.
7. FDA’s Official Action Indicated, available
at https://www.fda.gov/downloads/
AboutFDA/Transparency/
PublicDisclosure/
GlossaryofAcronymsandAbbreviations/
UCM212061.pdf.
8. 2017 FDA Investigations Operations
Manual (IOM) Chapter 5 at https://
www.fda.gov/ucm/groups/fdagov-public/
@fdagov-afda-ice/documents/document/
ucm123522.pdf.
9. FDA Compliance Program 7383.001 at
https://www.fda.gov/downloads/
MedicalDevices/
DeviceRegulationandGuidance/
MedicalDeviceQualityandCompliance/
UCM295570.pdf.
10. FDA Compliance Program 7382.845 at
https://www.fda.gov/downloads/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM244277.pdf.
11. Appendices A and B.
Dated: September 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–19258 Filed 9–11–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4515]
International Drug Scheduling;
Convention on Psychotropic
Substances; Single Convention on
Narcotic Drugs; Ocfentanil,
Carfentanil, Pregabalin, Tramadol,
Cannabidiol, Ketamine, and Eleven
Other Substances; Extension of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of comment
period.
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
notice that appeared in the Federal
Register of August 14, 2017. In the
notice, FDA requested comments
concerning abuse potential, actual
abuse, medical usefulness, trafficking,
and impact of scheduling changes on
availability for medical use of 17 drug
substances. The Agency is taking this
action in response to requests for an
extension to allow interested persons
additional time to submit comments.
DATES: FDA is extending the comment
period on the notice published August
14, 2017 (82 FR 37866). Submit either
electronic or written comments by
September 20, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before September 20,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 20, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
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]]>Agencies
[Federal Register Volume 82, Number 175 (Tuesday, September 12, 2017)]
[Notices]
[Pages 42815-42818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19258]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-4765]
Center for Devices and Radiological Health Premarket Approval
Application Critical to Quality Pilot Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration's (FDA or Agency or we)
Center for Devices and Radiological Health (CDRH or Center), Office of
Compliance (OC) and Office of In Vitro Diagnostics and Radiological
Health (OIR) is announcing its Premarket Approval Application Critical
to Quality (PMA CtQ) pilot program. Participation in the PMA CtQ pilot
program is voluntary and the program aims to evaluate device design and
manufacturing process quality information early on to assist FDA in its
review of the PMA manufacturing section and post-approval inspections.
This voluntary pilot program is part of the FDA's ongoing Case for
Quality effort to apply innovative strategies that promote medical
device quality and is a joint effort between the FDA's CDRH and Office
of Regulatory Affairs (ORA). The pilot program is intended to provide
qualifying PMA applicants with the option to engage FDA on development
of CtQ controls for their device and forego the standard PMA
preapproval inspection. FDA would in turn, focus on the PMA applicant's
implementation of the CtQ controls during a postmarket inspection.
DATES: FDA is seeking participation in the voluntary PMA CtQ pilot
program starting from September 29, 2017. See the ``Participation''
section for instructions on how to submit a request to participate.
This pilot program will run from September 29, 2017, to December 31,
2018. The voluntary PMA CtQ pilot program will accept the first nine
participants with submissions that meet the acceptance criteria.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-
[[Page 42816]]
2017-N-4765 for ``Center for Devices and Radiological Health Premarket
Approval Application Critical to Quality Pilot Program.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Bleta Vuniqi, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3463, Silver Spring, MD 20993, 301-796-5497,
Bleta.Vuniqi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
CDRH believes that proactive engagement with PMA applicants and a
focused inspectional approach will promote quality in device design and
manufacturing. CDRH plans to initiate the voluntary PMA CtQ pilot
program focusing on activities critical to product and process quality
starting September 29, 2017. The Center intends to work collaboratively
with PMA applicants identified to participate in the PMA CtQ pilot
program to define characteristics of the PMA device that are critical
to product quality and how these characteristics are controlled in
design and manufacturing prior to the postmarket inspection. PMA
applicants can expect discussions during the inspection to relate to
those factors most likely to impact device quality by working with FDA,
before PMA approval, on defining activities critical to product and
process quality. Improvements in overall device quality may reduce
device failures and recalls, and translate into more efficient
utilization of resources for CDRH, ORA, and the device industry.
Previously, CDRH's OC completed the implantable devices containing
batteries Critical to Quality Inspection pilot which established a
collaborative framework for determining specific operations, design
considerations, and controls that most impact the quality and safety of
these devices (Ref. 1). Post-inspection feedback from ORA and CDRH's OC
indicated that FDA can improve its approach for medical device
inspections by focusing on areas critical to quality of the device,
which in turn will change the compliance focus to influence better
device quality. In addition, feedback received from industry
participants indicated that many of the risks for devices reside in
product and process design and post-production activities.
Whether firms are appropriate candidates for participation in this
voluntary PMA CtQ pilot program is determined based on the factors
listed in Section A. Participation Criteria. Upon applicant's pre-PMA
q-submission meeting request, FDA will identify appropriate candidates
to participate in this voluntary pilot program. Due to resource
constraints, we intend to limit this voluntary pilot program to a
maximum of nine participants. FDA intends to work with each
participating applicant to identify characteristics of its device and
its manufacture that are critical to its quality, which may include
specific device features or quality control practices. The identified
CtQ characteristics and controls will help focus FDA's post-approval
inspectional approach.
The aim of the voluntary PMA CtQ pilot program is to have the
applicant discuss device design and manufacturing process quality
information with FDA early on to assist FDA in its review of the PMA
manufacturing section and post-approval inspections. The goal of this
voluntary pilot program is to streamline the premarket approval process
while assuring that a firm's quality system includes rigorous controls
for features and characteristics considered critical to the safety and
effectiveness of the device. FDA believes that focusing on these
activities may also lead to fewer device failures, a decrease in device
recalls, and improved device innovation and efficiencies. For
participants in the voluntary PMA CtQ pilot program, FDA intends to
forego conducting a preapproval inspection, which it would usually
conduct, and instead conduct a more focused post-approval inspection.
That post-approval inspection would focus on the design, manufacturing,
and quality assurance practices identified by the applicant in its PMA.
In addition, this voluntary pilot program is part of the FDA's ongoing
Case for Quality effort to apply innovative strategies that promote
medical device quality instead of focusing only on compliance with the
Quality System regulation (Ref. 2). This voluntary PMA CtQ pilot
program does not represent a new requirement; instead, it is an
opportunity to promote quality in device manufacturing, timely review
of the PMA manufacturing section and more effective use of inspectional
resources, and an enhanced opportunity to engage with firms regarding
device quality prior to marketing of the device. This voluntary PMA CtQ
pilot program augments the FDA's traditional Quality System Inspection
Technique (QSIT) inspectional approach, and does not replace it (Ref.
3).
Combination products, products regulated by the Center for
Biologics Evaluation and Research, and companion diagnostic In Vitro
Diagnostic devices that require coordination with the Center for Drug
Evaluation and Research are not within the scope of this voluntary PMA
CtQ pilot program.
A. Participation Criteria
Firms that are appropriate to participate in this voluntary PMA CtQ
pilot program are those firms submitting an original PMA who follow the
procedures set out in Section B and who also:
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1. Submit a request for a pre-PMA q-submission meeting, and
a. Provide the recommended information identified in the guidance
document, ``Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug Administration
Staff'' dated February 18, 2014 (Ref. 4), along with a statement of
interest for participation in this voluntary PMA CtQ pilot program in
the applicant's cover letter.
b. Provide a list of PMA-related facilities responsible for the
manufacture, processing, packing, or installation with the applicant's
pre-PMA q-submission submission package.
c. If available, submit a draft list of critical characteristics
for the device which is the subject of the PMA application.
2. As part of the PMA application, include the proposed list of
critical characteristics as well as their associated controls for the
device which is the subject of the PMA. The list should include
characteristics where failure in meeting the characteristic would have
a reasonable likelihood or a remote likelihood of causing a death or
serious injury.
3. Have their PMA application accepted and filed for review by FDA
(Ref. 5).
4. Have not had Quality System deficiencies identified in FDA's
review of the manufacturing section of the applicant's PMA (Ref. 6).
5. Have had an FDA inspection of the PMA-related facilities
conducted at least once within the last 5 years.
6. An FDA inspection of the PMA-related facilities has not been
classified as Official Action Indicated or been subject to a judicial
action (e.g., seizure or injunction, including consent decrees) within
the last 5 years (Ref. 7).
B. Procedures
Postmarket inspections under this proposed voluntary PMA CtQ pilot
program will be conducted in accordance with FDA's general
establishment inspection authority in section 704(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)). FDA intends for the
investigator to follow the current medical device inspection model as
outlined in the 2017 FDA Investigations Operations Manual (IOM) Chapter
5 and FDA Compliance Program 7383.001 ``Medical Device Premarket
Approval and Postmarket Inspections'' dated March 5, 2012, with the
following exceptions: (1) The inspection is conducted in the postmarket
setting and (2) the postmarket inspection includes an evaluation of
critical control measures for the production of the device are
implemented (Ref. 8-10). Section 5.1.2 of the IOM provides the
inspection may be directed for ``obtaining specific information on new
technologies, good commercial practices, or data for establishing food
standards or other regulations.''
Additionally, FDA intends on soliciting feedback from ORA, industry
participants, and CDRH's OC/OIR staff during the voluntary PMA CtQ
pilot program. Feedback from participants will be gathered through
meetings and questions proposed in Appendices A and B (Ref. 11).
The following captures FDA's expected process for the voluntary PMA
CtQ pilot program:
1. A firm submits a pre-PMA q-submission meeting request at least
75-90 days in advance of submission of the PMA application following
the recommendations outlined in the guidance document ``Requests for
Feedback on Medical Device Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration Staff'' (Ref. 4) dated
February 18, 2014. Additional expectations, include:
a. Providing a statement in the pre-PMA q-submission to support
being considered for participation in the voluntary PMA CtQ pilot
program.
b. Providing a list of PMA-related facilities responsible for the
manufacture, processing, packing, or installation for the device which
is the subject of the PMA as part of the applicant's pre-PMA q-
submission package.
c. If available, submitting a draft list of critical
characteristics for the device which is the subject of the PMA
application.
2. During the pre-PMA q-submission meeting, FDA clearly
communicates the voluntary PMA CtQ pilot program expectations and
discusses and provides the applicant's proposed draft list of critical
characteristics for the PMA device and provide feedback.
3. Once a firm has expressed interest in participating in the
voluntary PMA CtQ pilot program, CDRH determines whether:
a. all PMA-related facilities have been inspected within the last 5
years, and
b. all of the inspections of the PMA-related facilities have not
been classified as Official Action Indicated and have not been subject
to a judicial action (e.g., a seizure or injunction action, including a
consent decree) within the last 5 years.
4. The PMA application:
a. Is accepted and filed for review by FDA.
b. Includes as part of the manufacturing section the proposed list
of device critical characteristics as well as their associated
controls, which may include certain design, manufacturing, or quality
assurance practices. The list of critical characteristics identified in
4(b) is based on risk to the patient or user, including whether failure
in meeting the characteristic can have a reasonable likelihood or a
remote likelihood of causing a death or serious injury.
c. Is accompanied by a streamlined process validation report to
CDRH OC or OIR no later than day 45 within the PMA application process.
5. CDRH OC/OIR completes the following during review of the PMA
application:
a. Checks the CtQ information for clarity, completeness, and
relevance to the Quality System regulation within days 1-45, with the
goal to have the list of device critical characteristics as well as
their associated controls finalized by day 60 of the 180-day clock.
b. Reviews the manufacturing section of the PMA application within
the first 30 days of the 180-day clock. If Quality System deficiencies
are identified during this review, then the PMA application would no
longer be appropriate for inclusion in this voluntary PMA CtQ pilot
program. The reviewer would follow the current established procedures
and place the PMA application on ``hold'' pending correction of the
deficiencies.
c. Reviews the validation report identified in section B.4(c)
within 30 calendar days of receipt. Any concerns raised by the
validation report review may result in the issuance of a deficiency
letter that will place the PMA on ``hold'' pending Good Manufacturing
Practices corrections.
d. Provides an inspectional assignment to the investigator and
makes necessary technical expertise available to the ORA. The critical
characteristics and controls will help guide the investigator and
appropriately focus their activities during the postmarket inspection.
In addition, CDRH intends to include CtQ and control information in an
inspectional assignment and contact the investigator(s) to discuss
critical control measures and expectations prior to the inspection.
6. Following an approval decision, FDA conducts the postmarket
inspection in accordance with the 2017 FDA IOM, Compliance Program
7382.845, and Compliance Program 7383.001 (Ref. 8-10) utilizing
elements
[[Page 42818]]
of QSIT, and informed by the PMA CtQ information developed jointly by
FDA and the PMA applicant.
7. Following completion of the inspection, participating FDA
Offices and applicants provide the information/data needed to assess
the voluntary PMA CtQ pilot program's impact on resource utilization
and quality focus, utilizing the evaluation forms provided in
Appendices A and B (Ref. 11).
During this voluntary PMA CtQ pilot program, CDRH staff intends to
be available to answer questions or concerns that may arise. The
voluntary PMA CtQ pilot program participants will be asked to comment
on and discuss their experiences with the PMA CtQ pilot submission
process. Comments and discussions may assist FDA in determining whether
the goals of this voluntary PMA CtQ pilot program goal are clearly
communicated and attainable.
II. Duration of the Premarket Approval Application Critical to Quality
Pilot Program
FDA intends to accept requests for participation in the voluntary
PMA CtQ pilot program from September 29, 2017, to December 31, 2018, or
until such time as when a total of nine PMAs have been enrolled.
III. Paperwork Reduction Act of 1995
This notice 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 part 814, subparts A through E
have been approved under OMB control number 0910-0231; the collections
of information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; and the collections of information in ``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.
IV. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov. (FDA
has verified the Web site addresses, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
1. Implantable Devices that Contain Batteries Critical to Quality
Inspection Pilot. Available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/UCM469128.pdf.
2. FDA's Case for Quality, available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/ucm378185.htm.
3. FDA's Guide to Inspections of Quality Systems, Quality System
Inspection Technique, available at https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm.
4. FDA Guidance for Industry and FDA Staff ``Requests for Feedback
on Medical Device Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration Staff'' dated February
18, 2014. Available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm311176.pdf.
5. FDA's Guidance for Industry and FDA Staff: Acceptance and Filing
Reviews for Premarket Approval Applications (PMAs) at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm313368.pdf.
6. FDA's Guidance for Industry and FDA Staff: Quality System
Information for Certain Premarket Application Reviews, available at
https://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070897.htm.
7. FDA's Official Action Indicated, available at https://www.fda.gov/downloads/AboutFDA/Transparency/PublicDisclosure/GlossaryofAcronymsandAbbreviations/UCM212061.pdf.
8. 2017 FDA Investigations Operations Manual (IOM) Chapter 5 at
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-ice/documents/document/ucm123522.pdf.
9. FDA Compliance Program 7383.001 at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/UCM295570.pdf.
10. FDA Compliance Program 7382.845 at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM244277.pdf.
11. Appendices A and B.
Dated: September 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-19258 Filed 9-11-17; 8:45 am]
BILLING CODE 4164-01-P
