82 FR 61575 - Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 248 (December 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 248 (December 28, 2017)
| Page Range | 61575-61577 | |
| FR Document | 2017-28044 |
[Federal Register Volume 82, Number 248 (Thursday, December 28, 2017)] [Notices] [Pages 61575-61577] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-28044] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6778] Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration's (FDA or Agency or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program). The CfQ Pilot Program is voluntary and intends to evaluate product and manufacturing quality within the medical device ecosystem. The CfQ Pilot Program also intends to explore the effectiveness of a quality maturity appraisal, the use of objective metrics, optimization of resources, and impact on quality culture. The pilot program seeks to demonstrate better patient safety and outcomes, a lower regulatory burden on demonstrating quality assurance, and assure safety and effectiveness during product development and manufacturing. DATES: The CfQ Pilot Program will run from January 2, 2018, to December 28, 2018. See the ``Participation'' section for instructions on how to submit a request to participate. 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-2017-N-6778 for ``Case for Quality Voluntary Medical Device Manufacturing and Product Quality 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: Francisco Vicenty, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3426, Silver Spring, MD 20993, 301-796- 5577, [email protected]. SUPPLEMENTARY INFORMATION: I. Background As part of CDRH's 2016-2017 strategic priority to ``Promote a Culture of Quality and Organizational Excellence'' (Ref. 1), CDRH envisions a future state where the medical device ecosystem is inherently focused on device features and manufacturing practices that have the greatest impact on product quality and patient safety. Historically, FDA has evaluated manufacturers' compliance with regulations governing the design and production of devices. Compliance with the Quality System regulation, 21 CFR part 820, (Ref. 2) is a baseline requirement for medical device manufacturing firms. Focusing on elevating manufacturing quality practices gives greater emphasis to these practices, which should correlate to higher quality outcomes. This allows FDA to adjust how we recognize and incentivize behaviors and processes through which the safety and effectiveness of a medical device is [[Page 61576]] assured. CDRH intends to continue working with stakeholders to assess and promote manufacturers' implementation of manufacturing quality practices in routine device design and production. Through collaboration with the Medical Device Innovation Consortium (MDIC) over the last 2 years, a maturity model and appraisal system (i.e., Capability Maturity Model Integration (CMMI) system) that can be adapted for the medical device industry was selected (Ref. 3) for this CfQ Pilot Program. The CMMI system is a process level improvement, training, and appraisal program. The CMMI Institute administers this program whose stated goal is to help organizations discover the true value they can deliver by building capability in their people and processes (Ref. 4). This model has been successfully used in various industries, including information technology, healthcare, automotive, defense, and aerospace to consistently deliver high quality products and reduce waste and defects. The CMMI Institute certifies and coordinates third party appraisers evaluating voluntary industry participants and any data necessary to demonstrate product performance. The appraiser would evaluate the firm's quality system maturity and manufacturing processes, identify any gaps, and recognize when a participating firm performs above a compliance baseline. The CMMI maturity appraisal process is not intended to serve as an FDA inspection nor is it intended to be a new regulatory requirement. Conducting independent-assessments using a maturity model is intended to be a driver of continuous process and product improvement and add business value to voluntary participants in the CfQ Pilot Program. Assessments under the CMMI Institute are classified as Standard CMMI Appraisal Method for Process Improvement (SCAMPI) elements. A gap assessment (SCAMPI-C) will be a part of the CfQ Pilot Program. SCAMPI-C is a critical tool for developing an in-depth understanding of the medical device manufacturer's current state of process performance. SCAMPI-C is a short and flexible appraisal. It is used to assess the adequacy of planned approaches to process implementation and to provide a quick analysis between the organization's processes and CMMI practices. SCAMPI-C is intended to provide a rich dataset that reflects organizational performance and a comparison of the medical device manufacturer's performance against the CMMI model. FDA is announcing and soliciting participation for the voluntary medical device manufacturers CfQ Pilot Program. We intend to limit this voluntary pilot program to a maximum of nine participants. By participating in the third-party appraisal (SCAMPI-C), medical device manufacturers will receive an independent assessment of manufacturing and product quality intended to demonstrate sustained organizational excellence. By participating in the voluntary CfQ Pilot Program, FDA intends to forego conducting surveillance inspections. FDA will still conduct ``For Cause'' inspections where appropriate. The CMMI Institute will share the results of the SCAMPI-C appraisal with the manufacturer and develop a summary report to share with CDRH. Data collected through the appraisal and pilot will help inform FDA on how to modify its requirements around surveillance and preapproval inspections, as well as the content of premarket manufacturing submissions in order to better allocate resources and that could reduce the regulatory burden to appraised firms. The Center will continue an open dialog with the participants selected for the CfQ Pilot Program, medical device manufacturers and welcomes any feedback. For more information on the CfQ Pilot Program and how to enroll, please visit the website, http://mdic.org/cfq/enroll/. A. Participation FDA seeks participation in the CfQ Pilot Program beginning January 2, 2018. The CfQ Pilot Program will select up to nine participants who provide a holistic representation of the medical device industry and meet the selection criteria. Companies that may be eligible to participate in this voluntary CfQ Pilot Program are limited to those firms following the procedures set out in section B and that also meet the selection qualities that follow: 1. The company must be in good compliance standing (No Action Indicated or Voluntary Action Indicated classification from FDA inspection or MDSAP (Medical Device Single Audit Program) audit within the last 5 years). 2. While participating in the CfQ Pilot Program, the company must agree to: a. Appraisal(s) conducted by the CMMI Institute. b. Collect and submit developed metric data and provide it to CMMI for analysis. Details and templates for the data are provided as part of the scoping discussions for the appraisal. c. Be available for real-time consultations with FDA and CMMI. d. Participate in established monitoring activities with CMMI. e. Allow for reporting to FDA by CMMI of analyzed performance data. B. Procedures To be considered for the CfQ Pilot Program, a company should enroll at http://mdic.org/cfq/enroll/ or contact the CMMI Institute if you have questions at [email protected]. Additional details of the proposed process for the CfQ Pilot Program can be found at the following website: http://mdic.org/cfq/enroll/. During this CfQ Pilot Program, CDRH staff intends to be available to answer questions or concerns that may arise. The CfQ Pilot Program participants may comment on and discuss their experiences throughout the process with the Center and CMMI Institute. II. 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 820, regarding the Quality System regulations, have been approved under OMB control number 0910- 0073. III. References The following references are on display in the Dockets Management Staff (see ADDRESSES), and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. CDRH, 2016-2017 ``Promote a Culture of Quality and Organizational Excellence'' available at: https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM481588.pdf and CDRH's Case for Quality Initiative available at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/ucm378185.htm. 2. The Quality System regulation available at: https://www.ecfr.gov/cgi-bin/text-idx?SID=54a4a38f9c25eeab900b1c8f6c0f4212&mc=true&node=pt21.8.820&rgn=div5. 3. MDIC available at: http://mdic.org/. 4. CMMI system available at: http://cmmiinstitute.com/. [[Page 61577]] Dated: December 22, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-28044 Filed 12-27-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 248 / Thursday, December 28, 2017 / Notices 61575
FDA is committed to the orderly instructions for submitting comments. second copy, which will have the
conduct of its advisory committee Comments submitted electronically, claimed confidential information
meetings. Please visit our website at including attachments, to https:// redacted/blacked out, will be available
https://www.fda.gov/Advisory www.regulations.gov will be posted to for public viewing and posted on
Committees/AboutAdvisoryCommittees/ the docket unchanged. Because your https://www.regulations.gov. Submit
ucm111462.htm for procedures on comment will be made public, you are both copies to the Dockets Management
public conduct during advisory solely responsible for ensuring that your Staff. If you do not wish your name and
committee meetings. comment does not include any contact information to be made publicly
Notice of this meeting is given under confidential information that you or a available, you can provide this
the Federal Advisory Committee Act (5 third party may not wish to be posted, information on the cover sheet and not
U.S.C. app. 2). such as medical information, your or in the body of your comments and you
Dated: December 21, 2017. anyone else’s Social Security number, or must identify this information as
confidential business information, such ‘‘confidential.’’ Any information marked
Leslie Kux,
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Associate Commissioner for Policy. that if you include your name, contact except in accordance with 21 CFR 10.20
[FR Doc. 2017–27974 Filed 12–27–17; 8:45 am] information, or other information that and other applicable disclosure law. For
BILLING CODE 4164–01–P identifies you in the body of your more information about FDA’s posting
comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND • If you want to submit a comment the information at: https://www.gpo.gov/
HUMAN SERVICES with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
Food and Drug Administration public, submit the comment as a Docket: For access to the docket to
[Docket No. FDA–2017–N–6778] written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Fostering Medical Innovation: Case for Submissions’’ and ‘‘Instructions’’). received, go to https://
Quality Voluntary Medical Device www.regulations.gov and insert the
Manufacturing and Product Quality Written/Paper Submissions
docket number, found in brackets in the
Pilot Program Submit written/paper submissions as heading of this document, into the
follows: ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
HHS. and/or go to the Dockets Management
written/paper submissions): Dockets
ACTION: Notice. Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and
Rockville, MD 20852.
Drug Administration, 5630 Fishers
SUMMARY: The Food and Drug FOR FURTHER INFORMATION CONTACT:
Lane, Rm. 1061, Rockville, MD 20852.
Administration’s (FDA or Agency or we) • For written/paper comments Francisco Vicenty, Center for Devices
Center for Devices and Radiological submitted to the Dockets Management and Radiological Health, Food and Drug
Health (CDRH or Center) is announcing Staff, FDA will post your comment, as Administration, 10903 New Hampshire
its Case for Quality Voluntary Medical well as any attachments, except for Ave., Bldg. 66, Rm. 3426, Silver Spring,
Device Manufacturing and Product information submitted, marked and MD 20993, 301–796–5577,
Quality Pilot Program (CfQ Pilot identified, as confidential, if submitted Francisco.vicenty@fda.hhs.gov.
Program). The CfQ Pilot Program is as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION:
voluntary and intends to evaluate Instructions: All submissions received
product and manufacturing quality I. Background
must include the Docket No. FDA–
within the medical device ecosystem. 2017–N–6778 for ‘‘Case for Quality As part of CDRH’s 2016–2017
The CfQ Pilot Program also intends to Voluntary Medical Device strategic priority to ‘‘Promote a Culture
explore the effectiveness of a quality Manufacturing and Product Quality of Quality and Organizational
maturity appraisal, the use of objective Program.’’ Received comments will be Excellence’’ (Ref. 1), CDRH envisions a
metrics, optimization of resources, and placed in the docket and, except for future state where the medical device
impact on quality culture. The pilot those submitted as ‘‘Confidential ecosystem is inherently focused on
program seeks to demonstrate better Submissions,’’ publicly viewable at device features and manufacturing
patient safety and outcomes, a lower https://www.regulations.gov or at the practices that have the greatest impact
regulatory burden on demonstrating Dockets Management Staff between 9 on product quality and patient safety.
quality assurance, and assure safety and a.m. and 4 p.m., Monday through Historically, FDA has evaluated
effectiveness during product Friday. manufacturers’ compliance with
development and manufacturing. • Confidential Submissions—To regulations governing the design and
DATES: The CfQ Pilot Program will run submit a comment with confidential production of devices. Compliance with
from January 2, 2018, to December 28, information that you do not wish to be the Quality System regulation, 21 CFR
2018. See the ‘‘Participation’’ section for made publicly available, submit your part 820, (Ref. 2) is a baseline
instructions on how to submit a request comments only as a written/paper requirement for medical device
to participate. submission. You should submit two manufacturing firms. Focusing on
copies total. One copy will include the elevating manufacturing quality
sradovich on DSK3GMQ082PROD with NOTICES
ADDRESSES: You may submit comments
as follows: information you claim to be confidential practices gives greater emphasis to these
with a heading or cover note that states practices, which should correlate to
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS higher quality outcomes. This allows
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The FDA to adjust how we recognize and
following way: Agency will review this copy, including incentivize behaviors and processes
• Federal eRulemaking Portal: the claimed confidential information, in through which the safety and
https://www.regulations.gov. Follow the its consideration of comments. The effectiveness of a medical device is
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![Federal Register / Vol. 82, No. 248 / Thursday, December 28, 2017 / Notices 61577
Dated: December 22, 2017. directions of the Council and issues The meeting will be closed to the
Leslie Kux, related to physician workforce public in accordance with the
Associate Commissioner for Policy. development and graduate medical provisions set forth in sections
[FR Doc. 2017–28044 Filed 12–27–17; 8:45 am] education, leading to the selection of a 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
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Council on Graduate Medical hospitals within the Children’s Hospital
Education Name of Committee: National Eye Institute
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or make oral comments to the COGME (Catalogue of Federal Domestic Assistance
Maryland 20857. Participants may also Program Nos. 93.867, Vision Research,
access the meeting through to Kennita R. Carter, MD, Designated
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hrsa.connectsolutions.com/cogme- Rockville, MD 20857, requires a security Committee Policy.
council/. screening for entry. To facilitate access [FR Doc. 2017–27936 Filed 12–27–17; 8:45 am]
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Anyone requesting information attending the meeting should notify Dr.
regarding COGME should contact Kennita Carter at the contact
Kennita R. Carter, MD, Designated information listed above at least three DEPARTMENT OF THE INTERIOR
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and Dentistry, Bureau of Health Individuals who plan to attend and who Fish and Wildlife Service
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ACTION: Notice.
SUPPLEMENTARY INFORMATION: COGME [FR Doc. 2017–28015 Filed 12–27–17; 8:45 am]
provides advice and recommendations BILLING CODE 4165–15–P SUMMARY: The U.S. Department of the
to the Secretary of HHS and to Congress Interior (DOI) is establishing and
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nature and financing of medical DEPARTMENT OF HEALTH AND and Shooting Sports Conservation
education training, the development of HUMAN SERVICES Council (Council). The Council will
performance measures and longitudinal provide recommendations to the Federal
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sradovich on DSK3GMQ082PROD with NOTICES
evaluation methods of medical
education programs, foreign medical the Interior (Secretary) and the Secretary
National Eye Institute; Notice of Closed
school graduates, and the supply and of Agriculture, regarding the
Meeting
distribution of the physician workforce establishment and implementation of
in the United States, including any Pursuant to section 10(d) of the existing and proposed policies and
projected shortages or excesses. Federal Advisory Committee Act, as authorities with regard to wildlife and
During the meeting, the COGME amended, notice is hereby given of the habitat conservation endeavors that:
members will discuss the strategic following meeting. Benefit wildlife resources; encourage
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Document Created: 2017-12-28 00:43:56
Document Modified: 2017-12-28 00:43:56
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The CfQ Pilot Program will run from January 2, 2018, to December 28, 2018. See the ``Participation'' section for instructions on how to submit a request to participate. | |
| Contact | Francisco Vicenty, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3426, Silver Spring, MD 20993, 301-796- 5577, [email protected] | |
| FR Citation | 82 FR 61575 |
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