82_FR_42990 82 FR 42815 - Center for Devices and Radiological Health Premarket Approval Application Critical to Quality Pilot Program

82 FR 42815 - Center for Devices and Radiological Health Premarket Approval Application Critical to Quality Pilot Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 175 (September 12, 2017)

Page Range42815-42818
FR Document2017-19258

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.

Federal Register, Volume 82 Issue 175 (Tuesday, September 12, 2017) 
[Federal Register Volume 82, Number 175 (Tuesday, September 12, 2017)]
[Notices]
[Pages 42815-42818]
From the Federal Register Online  [www.thefederalregister.org]
[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.thefederalregister.org/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, 
[email protected].

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:

[[Page 42817]]

    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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/ucm378185.htm.
3. FDA's Guide to Inspections of Quality Systems, Quality System 
Inspection Technique, available at http://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 
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070897.htm.
7. FDA's Official Action Indicated, available at http://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 http://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

Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices 42815 unauthorized access to sensitive 1. Central Bancshares, Inc. to acquire, development of CtQ controls for their customer information, issues of through its newly formed subsidiaries, device and forego the standard PMA confidentiality may arise if the Board CBI Midco, Inc. and CBI Merger Sub, preapproval inspection. FDA would in were to obtain a copy of a customer Inc., all of Cambridge, Nebraska, up to turn, focus on the PMA applicant’s notice during the course of an 100 percent of the voting shares of implementation of the CtQ controls examination, a copy of a SAR, or other Republic Corporation, and thereby during a postmarket inspection. sensitive customer information. In such indirectly acquire United Republic DATES: FDA is seeking participation in cases, the information would likely be Bank, both of Omaha, Nebraska. the voluntary PMA CtQ pilot program exempt from disclosure to the public In connection with this application starting from September 29, 2017. See under the Freedom of Information Act CBI Midco, Inc. and CBI Merger Sub, the ‘‘Participation’’ section for (5 U.S.C. 552(b)(3), (4), (6), and (8)). Inc., have applied to become bank instructions on how to submit a request Also, a federal employee is prohibited holding companies. to participate. This pilot program will by law from disclosing a SAR or the B. Federal Reserve Bank of San run from September 29, 2017, to existence of a SAR (31 U.S.C. 5318(g)). Francisco (Gerald C. Tsai, Director, December 31, 2018. The voluntary PMA Board of Governors of the Federal Reserve Applications and Enforcement) 101 CtQ pilot program will accept the first System, September 6, 2017. Market Street, San Francisco, California nine participants with submissions that Ann E. Misback, 94105–1579: meet the acceptance criteria. Secretary of the Board. 1. Pacific Premier Bancorp, Inc.; to ADDRESSES: You may submit comments [FR Doc. 2017–19217 Filed 9–11–17; 8:45 am] acquire 100 percent of Plaza Bancorp, as follows: and thereby indirectly acquire Plaza BILLING CODE 6210–01–P Bank, all of Irvine, California. Electronic Submissions Board of Governors of the Federal Reserve Submit electronic comments in the FEDERAL RESERVE SYSTEM System, September 6, 2017. following way: • Federal eRulemaking Portal: Yao-Chin Chao, Formations of, Acquisitions by, and https://www.regulations.gov. Follow the Assistant Secretary of the Board. instructions for submitting comments. Mergers of Bank Holding Companies [FR Doc. 2017–19211 Filed 9–11–17; 8:45 am] Comments submitted electronically, The companies listed in this notice BILLING CODE 6210–01–P including attachments, to https:// have applied to the Board for approval, www.regulations.gov will be posted to pursuant to the Bank Holding Company the docket unchanged. Because your Act of 1956 (12 U.S.C. 1841 et seq.) DEPARTMENT OF HEALTH AND comment will be made public, you are (BHC Act), Regulation Y (12 CFR part HUMAN SERVICES solely responsible for ensuring that your 225), and all other applicable statutes comment does not include any and regulations to become a bank Food and Drug Administration confidential information that you or a holding company and/or to acquire the third party may not wish to be posted, [Docket No. FDA–2017–N–4765] assets or the ownership of, control of, or such as medical information, your or the power to vote shares of a bank or Center for Devices and Radiological anyone else’s Social Security number, or bank holding company and all of the Health Premarket Approval Application confidential business information, such banks and nonbanking companies Critical to Quality Pilot Program as a manufacturing process. Please note owned by the bank holding company, that if you include your name, contact including the companies listed below. AGENCY: Food and Drug Administration, information, or other information that The applications listed below, as well HHS. identifies you in the body of your as other related filings required by the ACTION: Notice. comments, that information will be Board, are available for immediate posted on https://www.regulations.gov. inspection at the Federal Reserve Bank SUMMARY: The Food and Drug • If you want to submit a comment indicated. The applications will also be Administration’s (FDA or Agency or we) with confidential information that you available for inspection at the offices of Center for Devices and Radiological do not wish to be made available to the the Board of Governors. Interested Health (CDRH or Center), Office of public, submit the comment as a persons may express their views in Compliance (OC) and Office of In Vitro written/paper submission and in the writing on the standards enumerated in Diagnostics and Radiological Health manner detailed (see ‘‘Written/Paper the BHC Act (12 U.S.C. 1842(c)). If the (OIR) is announcing its Premarket Submissions’’ and ‘‘Instructions’’). proposal also involves the acquisition of Approval Application Critical to Quality a nonbanking company, the review also (PMA CtQ) pilot program. Participation Written/Paper Submissions includes whether the acquisition of the in the PMA CtQ pilot program is Submit written/paper submissions as nonbanking company complies with the voluntary and the program aims to follows: standards in section 4 of the BHC Act evaluate device design and • Mail/Hand delivery/Courier (for (12 U.S.C. 1843). Unless otherwise manufacturing process quality written/paper submissions): Dockets noted, nonbanking activities will be information early on to assist FDA in its Management Staff (HFA–305), Food and conducted throughout the United States. review of the PMA manufacturing Drug Administration, 5630 Fishers Unless otherwise noted, comments section and post-approval inspections. Lane, Rm. 1061, Rockville, MD 20852. regarding each of these applications This voluntary pilot program is part of • For written/paper comments pmangrum on DSK3GDR082PROD with NOTICES1 must be received at the Reserve Bank the FDA’s ongoing Case for Quality submitted to the Dockets Management indicated or the offices of the Board of effort to apply innovative strategies that Staff, FDA will post your comment, as Governors not later than October 5, promote medical device quality and is well as any attachments, except for 2017. a joint effort between the FDA’s CDRH information submitted, marked and A. Federal Reserve Bank of Kansas and Office of Regulatory Affairs (ORA). identified, as confidential, if submitted City (Dennis Denney, Assistant Vice The pilot program is intended to as detailed in ‘‘Instructions.’’ President) 1 Memorial Drive, Kansas provide qualifying PMA applicants with Instructions: All submissions received City, Missouri 64198–0001: the option to engage FDA on must include the Docket No. FDA– VerDate Sep<11>2014 15:19 Sep 11, 2017 Jkt 241001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\12SEN1.SGM 12SEN1

42816 Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices 2017–N–4765 for ‘‘Center for Devices I. Background focus FDA’s post-approval inspectional and Radiological Health Premarket CDRH believes that proactive approach. Approval Application Critical to Quality engagement with PMA applicants and a The aim of the voluntary PMA CtQ Pilot Program.’’ Received comments will focused inspectional approach will pilot program is to have the applicant be placed in the docket and, except for promote quality in device design and discuss device design and those submitted as ‘‘Confidential manufacturing. CDRH plans to initiate manufacturing process quality Submissions,’’ publicly viewable at the voluntary PMA CtQ pilot program information with FDA early on to assist https://www.regulations.gov or at the focusing on activities critical to product FDA in its review of the PMA Dockets Management Staff between 9 and process quality starting September manufacturing section and post- a.m. and 4 p.m., Monday through 29, 2017. The Center intends to work approval inspections. The goal of this Friday. collaboratively with PMA applicants voluntary pilot program is to streamline • Confidential Submissions—To identified to participate in the PMA CtQ the premarket approval process while submit a comment with confidential pilot program to define characteristics of assuring that a firm’s quality system information that you do not wish to be the PMA device that are critical to includes rigorous controls for features made publicly available, submit your product quality and how these and characteristics considered critical to comments only as a written/paper characteristics are controlled in design the safety and effectiveness of the submission. You should submit two and manufacturing prior to the device. FDA believes that focusing on copies total. One copy will include the postmarket inspection. PMA applicants these activities may also lead to fewer information you claim to be confidential can expect discussions during the device failures, a decrease in device with a heading or cover note that states inspection to relate to those factors most recalls, and improved device innovation ‘‘THIS DOCUMENT CONTAINS likely to impact device quality by and efficiencies. For participants in the CONFIDENTIAL INFORMATION.’’ The working with FDA, before PMA voluntary PMA CtQ pilot program, FDA Agency will review this copy, including approval, on defining activities critical intends to forego conducting a the claimed confidential information, in to product and process quality. preapproval inspection, which it would Improvements in overall device quality usually conduct, and instead conduct a its consideration of comments. The may reduce device failures and recalls, more focused post-approval inspection. second copy, which will have the and translate into more efficient That post-approval inspection would claimed confidential information utilization of resources for CDRH, ORA, focus on the design, manufacturing, and redacted/blacked out, will be available and the device industry. Previously, quality assurance practices identified by for public viewing and posted on CDRH’s OC completed the implantable the applicant in its PMA. In addition, https://www.regulations.gov. Submit devices containing batteries Critical to this voluntary pilot program is part of both copies to the Dockets Management Quality Inspection pilot which the FDA’s ongoing Case for Quality Staff. If you do not wish your name and established a collaborative framework effort to apply innovative strategies that contact information to be made publicly for determining specific operations, promote medical device quality instead available, you can provide this design considerations, and controls that of focusing only on compliance with the information on the cover sheet and not Quality System regulation (Ref. 2). This in the body of your comments and you most impact the quality and safety of these devices (Ref. 1). Post-inspection voluntary PMA CtQ pilot program does must identify this information as not represent a new requirement; ‘‘confidential.’’ Any information marked feedback from ORA and CDRH’s OC indicated that FDA can improve its instead, it is an opportunity to promote as ‘‘confidential’’ will not be disclosed quality in device manufacturing, timely except in accordance with 21 CFR 10.20 approach for medical device inspections by focusing on areas critical to quality review of the PMA manufacturing and other applicable disclosure law. For section and more effective use of more information about FDA’s posting of the device, which in turn will change the compliance focus to influence better inspectional resources, and an enhanced of comments to public dockets, see 80 opportunity to engage with firms device quality. In addition, feedback FR 56469, September 18, 2015, or access regarding device quality prior to received from industry participants the information at: https://www.gpo.gov/ marketing of the device. This voluntary indicated that many of the risks for fdsys/pkg/FR-2015-09-18/pdf/2015- PMA CtQ pilot program augments the devices reside in product and process 23389.pdf. FDA’s traditional Quality System design and post-production activities. Docket: For access to the docket to Whether firms are appropriate Inspection Technique (QSIT) read background documents or the candidates for participation in this inspectional approach, and does not electronic and written/paper comments voluntary PMA CtQ pilot program is replace it (Ref. 3). received, go to https:// determined based on the factors listed Combination products, products www.regulations.gov and insert the in Section A. Participation Criteria. regulated by the Center for Biologics docket number, found in brackets in the Upon applicant’s pre-PMA q- Evaluation and Research, and heading of this document, into the submission meeting request, FDA will companion diagnostic In Vitro ‘‘Search’’ box and follow the prompts identify appropriate candidates to Diagnostic devices that require and/or go to the Dockets Management participate in this voluntary pilot coordination with the Center for Drug Staff, 5630 Fishers Lane, Rm. 1061, program. Due to resource constraints, Evaluation and Research are not within Rockville, MD 20852. we intend to limit this voluntary pilot the scope of this voluntary PMA CtQ program to a maximum of nine pilot program. FOR FURTHER INFORMATION CONTACT: pmangrum on DSK3GDR082PROD with NOTICES1 participants. FDA intends to work with Bleta Vuniqi, Center for Devices and A. Participation Criteria each participating applicant to identify Radiological Health, Food and Drug characteristics of its device and its Firms that are appropriate to Administration, 10903 New Hampshire manufacture that are critical to its participate in this voluntary PMA CtQ Ave., Bldg. 66, Rm. 3463, Silver Spring, quality, which may include specific pilot program are those firms submitting MD 20993, 301–796–5497, device features or quality control an original PMA who follow the Bleta.Vuniqi@fda.hhs.gov. practices. The identified CtQ procedures set out in Section B and who SUPPLEMENTARY INFORMATION: characteristics and controls will help also: VerDate Sep<11>2014 15:19 Sep 11, 2017 Jkt 241001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\12SEN1.SGM 12SEN1

Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices 42817 1. Submit a request for a pre-PMA q- evaluation of critical control measures a. Is accepted and filed for review by submission meeting, and for the production of the device are FDA. a. Provide the recommended implemented (Ref. 8–10). Section 5.1.2 b. Includes as part of the information identified in the guidance of the IOM provides the inspection may manufacturing section the proposed list document, ‘‘Requests for Feedback on be directed for ‘‘obtaining specific of device critical characteristics as well Medical Device Submissions: The Pre- information on new technologies, good as their associated controls, which may Submission Program and Meetings with commercial practices, or data for include certain design, manufacturing, Food and Drug Administration Staff’’ establishing food standards or other or quality assurance practices. The list dated February 18, 2014 (Ref. 4), along regulations.’’ of critical characteristics identified in with a statement of interest for Additionally, FDA intends on 4(b) is based on risk to the patient or participation in this voluntary PMA CtQ soliciting feedback from ORA, industry user, including whether failure in pilot program in the applicant’s cover participants, and CDRH’s OC/OIR staff meeting the characteristic can have a letter. during the voluntary PMA CtQ pilot reasonable likelihood or a remote b. Provide a list of PMA-related program. Feedback from participants likelihood of causing a death or serious facilities responsible for the will be gathered through meetings and injury. manufacture, processing, packing, or questions proposed in Appendices A c. Is accompanied by a streamlined installation with the applicant’s pre- and B (Ref. 11). process validation report to CDRH OC or PMA q-submission submission package. The following captures FDA’s OIR no later than day 45 within the c. If available, submit a draft list of expected process for the voluntary PMA PMA application process. critical characteristics for the device CtQ pilot program: 5. CDRH OC/OIR completes the which is the subject of the PMA following during review of the PMA 1. A firm submits a pre-PMA q- application. application: submission meeting request at least 75– 2. As part of the PMA application, a. Checks the CtQ information for 90 days in advance of submission of the include the proposed list of critical clarity, completeness, and relevance to PMA application following the characteristics as well as their the Quality System regulation within recommendations outlined in the associated controls for the device which days 1–45, with the goal to have the list guidance document ‘‘Requests for is the subject of the PMA. The list of device critical characteristics as well Feedback on Medical Device should include characteristics where as their associated controls finalized by Submissions: The Pre-Submission failure in meeting the characteristic day 60 of the 180-day clock. Program and Meetings with Food and b. Reviews the manufacturing section would have a reasonable likelihood or a Drug Administration Staff’’ (Ref. 4) remote likelihood of causing a death or of the PMA application within the first dated February 18, 2014. Additional 30 days of the 180-day clock. If Quality serious injury. expectations, include: 3. Have their PMA application System deficiencies are identified a. Providing a statement in the pre- during this review, then the PMA accepted and filed for review by FDA PMA q-submission to support being application would no longer be (Ref. 5). 4. Have not had Quality System considered for participation in the appropriate for inclusion in this deficiencies identified in FDA’s review voluntary PMA CtQ pilot program. voluntary PMA CtQ pilot program. The of the manufacturing section of the b. Providing a list of PMA-related reviewer would follow the current applicant’s PMA (Ref. 6). facilities responsible for the established procedures and place the 5. Have had an FDA inspection of the manufacture, processing, packing, or PMA application on ‘‘hold’’ pending PMA-related facilities conducted at least installation for the device which is the correction of the deficiencies. once within the last 5 years. subject of the PMA as part of the c. Reviews the validation report 6. An FDA inspection of the PMA- applicant’s pre-PMA q-submission identified in section B.4(c) within 30 related facilities has not been classified package. calendar days of receipt. Any concerns as Official Action Indicated or been c. If available, submitting a draft list raised by the validation report review subject to a judicial action (e.g., seizure of critical characteristics for the device may result in the issuance of a or injunction, including consent which is the subject of the PMA deficiency letter that will place the PMA decrees) within the last 5 years (Ref. 7). application. on ‘‘hold’’ pending Good Manufacturing 2. During the pre-PMA q-submission Practices corrections. B. Procedures meeting, FDA clearly communicates the d. Provides an inspectional Postmarket inspections under this voluntary PMA CtQ pilot program assignment to the investigator and proposed voluntary PMA CtQ pilot expectations and discusses and provides makes necessary technical expertise program will be conducted in the applicant’s proposed draft list of available to the ORA. The critical accordance with FDA’s general critical characteristics for the PMA characteristics and controls will help establishment inspection authority in device and provide feedback. guide the investigator and appropriately section 704(a) of the Federal Food, Drug, 3. Once a firm has expressed interest focus their activities during the and Cosmetic Act (21 U.S.C. 374(a)). in participating in the voluntary PMA postmarket inspection. In addition, FDA intends for the investigator to CtQ pilot program, CDRH determines CDRH intends to include CtQ and follow the current medical device whether: control information in an inspectional inspection model as outlined in the a. all PMA-related facilities have been assignment and contact the 2017 FDA Investigations Operations inspected within the last 5 years, and investigator(s) to discuss critical control pmangrum on DSK3GDR082PROD with NOTICES1 Manual (IOM) Chapter 5 and FDA b. all of the inspections of the PMA- measures and expectations prior to the Compliance Program 7383.001 ‘‘Medical related facilities have not been classified inspection. Device Premarket Approval and as Official Action Indicated and have 6. Following an approval decision, Postmarket Inspections’’ dated March 5, not been subject to a judicial action FDA conducts the postmarket 2012, with the following exceptions: (1) (e.g., a seizure or injunction action, inspection in accordance with the 2017 The inspection is conducted in the including a consent decree) within the FDA IOM, Compliance Program postmarket setting and (2) the last 5 years. 7382.845, and Compliance Program postmarket inspection includes an 4. The PMA application: 7383.001 (Ref. 8–10) utilizing elements VerDate Sep<11>2014 15:19 Sep 11, 2017 Jkt 241001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\12SEN1.SGM 12SEN1

42818 Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices of QSIT, and informed by the PMA CtQ to the Web sites after this document DEPARTMENT OF HEALTH AND information developed jointly by FDA publishes in the Federal Register.) HUMAN SERVICES and the PMA applicant. 1. Implantable Devices that Contain Batteries 7. Following completion of the Critical to Quality Inspection Pilot. Food and Drug Administration inspection, participating FDA Offices Available at https://www.fda.gov/ [Docket No. FDA–2017–N–4515] and applicants provide the information/ downloads/MedicalDevices/ data needed to assess the voluntary DeviceRegulationandGuidance/ International Drug Scheduling; PMA CtQ pilot program’s impact on MedicalDeviceQualityandCompliance/ Convention on Psychotropic resource utilization and quality focus, UCM469128.pdf. Substances; Single Convention on utilizing the evaluation forms provided 2. FDA’s Case for Quality, available at http:// Narcotic Drugs; Ocfentanil, in Appendices A and B (Ref. 11). www.fda.gov/MedicalDevices/ Carfentanil, Pregabalin, Tramadol, During this voluntary PMA CtQ pilot DeviceRegulationandGuidance/ Cannabidiol, Ketamine, and Eleven program, CDRH staff intends to be MedicalDeviceQualityandCompliance/ Other Substances; Extension of available to answer questions or ucm378185.htm. Comment Period concerns that may arise. The voluntary 3. FDA’s Guide to Inspections of Quality PMA CtQ pilot program participants Systems, Quality System Inspection AGENCY: Food and Drug Administration, will be asked to comment on and Technique, available at http:// HHS. discuss their experiences with the PMA www.fda.gov/ICECI/Inspections/ ACTION: Notice; extension of comment CtQ pilot submission process. InspectionGuides/ucm074883.htm. period. Comments and discussions may assist 4. FDA Guidance for Industry and FDA Staff ‘‘Requests for Feedback on Medical SUMMARY: The Food and Drug FDA in determining whether the goals Device Submissions: The Pre- Administration (FDA or the Agency) is of this voluntary PMA CtQ pilot Submission Program and Meetings with extending the comment period for the program goal are clearly communicated notice that appeared in the Federal Food and Drug Administration Staff’’ and attainable. Register of August 14, 2017. In the dated February 18, 2014. Available at II. Duration of the Premarket Approval https://www.fda.gov/ucm/groups/fdagov- notice, FDA requested comments Application Critical to Quality Pilot public/@fdagov-meddev-gen/documents/ concerning abuse potential, actual Program document/ucm311176.pdf. abuse, medical usefulness, trafficking, 5. FDA’s Guidance for Industry and FDA and impact of scheduling changes on FDA intends to accept requests for Staff: Acceptance and Filing Reviews for participation in the voluntary PMA CtQ availability for medical use of 17 drug Premarket Approval Applications substances. The Agency is taking this pilot program from September 29, 2017, (PMAs) at https://www.fda.gov/ucm/ to December 31, 2018, or until such time action in response to requests for an groups/fdagov-public/@fdagov-meddev- extension to allow interested persons as when a total of nine PMAs have been gen/documents/document/ enrolled. additional time to submit comments. ucm313368.pdf. DATES: FDA is extending the comment III. Paperwork Reduction Act of 1995 6. FDA’s Guidance for Industry and FDA Staff: Quality System Information for period on the notice published August This notice refers to previously Certain Premarket Application Reviews, 14, 2017 (82 FR 37866). Submit either approved collections of information available at http://www.fda.gov/ electronic or written comments by found in FDA regulations. These medicaldevices/ September 20, 2017. collections of information are subject to deviceregulationandguidance/ ADDRESSES: You may submit comments review by the Office of Management and guidancedocuments/ucm070897.htm. as follows. Please note that late, Budget (OMB) under the Paperwork 7. FDA’s Official Action Indicated, available untimely filed comments will not be Reduction Act of 1995 (44 U.S.C. 3501– at http://www.fda.gov/downloads/ considered. Electronic comments must 3520). The collections of information in AboutFDA/Transparency/ be submitted on or before September 20, 21 CFR part 814, subparts A through E PublicDisclosure/ 2017. The https://www.regulations.gov have been approved under OMB control GlossaryofAcronymsandAbbreviations/ electronic filing system will accept number 0910–0231; the collections of UCM212061.pdf. comments until midnight Eastern Time information in 21 CFR part 820 have 8. 2017 FDA Investigations Operations at the end of September 20, 2017. been approved under OMB control Manual (IOM) Chapter 5 at https:// Comments received by mail/hand www.fda.gov/ucm/groups/fdagov-public/ number 0910–0073; and the collections delivery/courier (for written/paper @fdagov-afda-ice/documents/document/ of information in ‘‘Requests for submissions) will be considered timely ucm123522.pdf. Feedback on Medical Device 9. FDA Compliance Program 7383.001 at if they are postmarked or the delivery Submissions: The Pre-Submission http://www.fda.gov/downloads/ service acceptance receipt is on or Program and Meetings with Food and MedicalDevices/ before that date. Drug Administration Staff’’ have been DeviceRegulationandGuidance/ approved under OMB control number Electronic Submissions MedicalDeviceQualityandCompliance/ 0910–0756. UCM295570.pdf. Submit electronic comments in the 10. FDA Compliance Program 7382.845 at following way: IV. References • Federal eRulemaking Portal: https://www.fda.gov/downloads/ The following references have been MedicalDevices/ https://www.regulations.gov. Follow the placed on display in the Division of DeviceRegulationandGuidance/ instructions for submitting comments. pmangrum on DSK3GDR082PROD with NOTICES1 Dockets Management (see ADDRESSES), GuidanceDocuments/UCM244277.pdf. Comments submitted electronically, and may be seen by interested persons 11. Appendices A and B. including attachments, to https:// between 9 a.m. and 4 p.m., Monday Dated: September 5, 2017. www.regulations.gov will be posted to through Friday, and are available the docket unchanged. Because your Leslie Kux, electronically at https:// comment will be made public, you are www.regulations.gov. (FDA has verified Associate Commissioner for Policy. solely responsible for ensuring that your the Web site addresses, but we are not [FR Doc. 2017–19258 Filed 9–11–17; 8:45 am] comment does not include any responsible for any subsequent changes BILLING CODE 4164–01–P confidential information that you or a VerDate Sep<11>2014 15:19 Sep 11, 2017 Jkt 241001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\12SEN1.SGM 12SEN1


Document Created: 2018-10-24 14:16:20
Document Modified: 2018-10-24 14:16:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFDA 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.
ContactBleta 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, [email protected]
FR Citation82 FR 42815 
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