80 FR 50293 - Center for Devices and Radiological Health Participation in International Medical Device Regulators Forum, Regulated Product Submission, Table of Contents Pilot Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 160 (August 19, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 160 (August 19, 2015)
| Page Range | 50293-50295 | |
| FR Document | 2015-20430 |
[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)] [Notices] [Pages 50293-50295] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-20430] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-2458] Center for Devices and Radiological Health Participation in International Medical Device Regulators Forum, Regulated Product Submission, Table of Contents Pilot Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH), Offices of Device Evaluation (ODE) and In Vitro Diagnostics and Radiation (OIR) are announcing their participation in the International Medical Device Regulators Forum's (IMDRF) Regulated Product Submission Table of Contents Pilot Program. Participation in the Pilot is voluntary and open to applicants who submit premarket approval (PMA) applications or premarket notification (510(k)) to either ODE or OIR. The Pilot project is intended to provide industry, IMDRF, and CDRH staff the opportunity to evaluate the Table of Contents structure and to receive input from industry participants. Participants will be asked to submit their submissions electronically using IMDRF's Table of Contents (ToC) format. DATES: The IMDRF is seeking interest for participation in the voluntary IMDRF Regulated Product Submission, Table of Contents Pilot Program. See section II.A. for instructions on how to submit a request to participate. The Pilot project will accept submissions with the ToC structure starting September 2015 through September 2016. FOR FURTHER INFORMATION CONTACT: Jodi Hope N. Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1520, Silver Spring, MD 20993, 301- 796-9299, [email protected]. SUPPLEMENTARY INFORMATION: I. Background The IMDRF was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization. It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force. The Forum aims to accelerate international medical device regulatory harmonization and convergence. The Regulated Product Submission (RPS) proposal was endorsed as a new work item by IMDRF at its 2012 inaugural meeting in Singapore. The Work Group, consisting of regulatory authorities from the United States, European Union (EU), Australia, Brazil, Japan, China, and Canada, created a comprehensive Table of Contents for Non-In Vitro Diagnostics (nIVD) and also for IVD Marketing Authorizations, which were formalized in August 2014. The ToC provides a comprehensive submission structure that can be used as a harmonized international electronic submission format while minimizing regional divergences and indicating where regional variation exists. This document is intended to provide guidance regarding the location of submission elements. These documents can be found on IMDRF's Web site (Refs. 1 and 2). This document is intended to work together with a regional classification matrix, a separate document created for each participating jurisdiction. The classification matrix defines whether a heading is required, not required, optional, conditionally required, etc., for the given submission type. FDA's Classification Matrices can be found on FDA's Web site (Ref. 3). The ToC Work Group has previously conducted Pilots for both of the ToC structures, using historical submissions. These Pilots provided valuable feedback regarding the ToC structure and completeness; however, there were limitations to using historical submissions and also a limited number of samples involving submission to more than one jurisdiction. Furthermore, there were no specific guidelines regarding the means of building a submission in a non-standard implementation. Additional IMDRF testing is considered necessary to both evaluate the ToC structures using real regulatory submissions and also evaluate the ToC structure from an industry perspective. II. CDRH Participation in IMDRF Regulated Product Submission Table of Contents (ToC) Implementation Pilot FDA's participation in the IMDRF RPS ToC Implementation Pilot will provide both local and international benefits for FDA, as it will provide FDA feedback into decisions regarding the ToC's suitability. CDRH is participating in the Pilot. In doing so, CDRH will receive premarket submissions from the medical device regulated industry using the IMDRF ToC and FDA Regional Classification Matrices. Applications are to be real regulatory submissions--either PMAs or 510(k) applications--that will result in regulatory decisions by CDRH. PMAs exclude combination products and bundled submissions. The 510(k)s exclude special, abbreviated, and third-party submissions, as well as combination products, bundled submissions, and amendments after a final decision. Pilot participation requires that an application submitted to FDA also be submitted sequentially or simultaneously to at least one additional participating IMDRF region. Currently the participating regulating authorities are Australia (Therapeutic Goods Administration), Brazil (ANVISA), Canada (Health Canada), China (China Food and Drug Administration), and the European Union (Notified Bodies). The Pilot is described in greater detail in the IMDRF/RPS WG/N26 Informational Document ``IMDRF Table of Contents (ToC) Pilot Plan'' (Ref. 4). The Regulators participating in this Pilot intend to use submissions only for the requested regulatory activity and objectives of this Pilot. Any submissions generated in relation to this testing will not be distributed to other manufacturers or other regulators. Industry participants should share any submission content directly with the appropriate regulators through the official regulatory processes in place--i.e., submission content will be shared across regulators directly by regulated industry. Feedback provided on the ToC structure, experience developing regulatory submissions, or suggestions [[Page 50294]] for additional ToC headings may be shared and made public, excluding any confidential content. Basic applicant and submission identifying information (e.g., Applicant/Correspondent/Manufacturer Name, Device Name, Device Type, and Submission Type) will be shared among IMDRF Regulators for the purpose of conducting the Pilot. The invitation to participants will provide the specific details of the information to be shared among the Regulators as it is a condition for Pilot participation. Any information provided in the resulting Pilot findings should only disclose information explicitly stated as releasable. This Pilot will be evaluated in accordance with current FDA protocols and performance standards. Feedback from reviewers will be provided on the reviewability of the submission, based on the IMDRF ToC and FDA classification matrix, and any observations regarding issues in the submission content elements of the ToC Pilot. Feedback from industry will be accepted throughout the submission building process. The Pilot project is intended to provide industry, IMDRF, and CDRH staff the opportunity to evaluate the ToC structure, through the receipt of input from industry participants and CDRH staff. Comments received during the Pilot project will be used to evaluate the usability of the ToC format. FDA will be reviewing the contents of each submission as part of this Pilot; however, Pilot participation for the manufacturer will end after successfully passing the refuse to accept criteria. Subsequently, a complete scientific review, outside of the scope of the Pilot, will commence. A. Participation Volunteers interested in participating in the Pilot project should provide expressions of interest to the IMDRF ToC working group at the IMDRF ToC email account [email protected]. Confirmation of your interest in participation in the IMDRF ToC Pilot plan is requested. If notification is received by August 21, 2015, then the manufacturer will be invited to participate in a ``participation teleconference'' to answer remaining questions. After August 21, 2015, contact FDA Pilot staff by email at [email protected] with any questions. The following information should be included in the request: Applicant, trade name, primary product code, submission type, contact name, and contact email. FDA will contact interested applicants to discuss the Pilot project. FDA is seeking a limited number of participants (no more than nine) to participate in this Pilot project. Participants must adhere to FDA's submission requirements (i.e., eCopy) and Refuse to Accept (RTA) requirements (Refs. 5 and 6). B. Procedures After reading the ToC Pilot Plan document, applicants use either the nIVD or IVD ToC documents, as well as the respective Classification Matrix to construct their submission. The submission, placed into a single .zip file with the name ``MISC FILES.zip'' is then loaded onto media via eCopy (e.g., CD, DVD, SD card, USB drive). No paper copy of the submission is needed. All submissions are still expected to comply with the respective PMA or 510(k) RTA guidance documents. All submissions are still expected to comply with the FDA's eCopy Program for Medical Device Submissions Final Guidance (Ref. 5), except for the following: (1) With the exception of the cover letter, all sections discussing paper copy requirements may be disregarded; (2) sections outside the scope of the Pilot (e.g., sections pertaining to Bundled Submissions) may be disregarded; and (3) Attachment A, Part B of the eCopy Guidance is superseded by the ToC document. Applicants are required to provide a paper cover letter, meeting the technical guidance provided in the eCopy Guidance Document, Attachment 1, Part A. In addition, the following statement must be included in bold: This submission is part of the IMDRF ToC Pilot, and is organized according to the IMDRF ToC. Accordingly, special eCopy processing applies. As per the agreement for this ToC Pilot, no full paper copies are required, and the specially-formatted submission is zipped and placed within a MISC FILES folder in the eCopy. The cover letter and media should be sent via mail to the Document Control Center (DCC) to: Food and Drug Administration, Center for Devices and Radiological Health, Document Control Center, Bldg. 66, Rm. G609, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002 ATTN: IMDRF ToC Pilot Submission. During the Pilot, CDRH staff will be available to answer any questions or concerns that may arise. Pilot project participants will be asked to comment on and discuss their experiences with the Pilot submissions process. Their input and discussions will assist both IMDRF and CDRH in their use of the ToC in future electronic submission formats. III. Duration of the IMDRF Regulated Product Submission ToC Implementation Pilot FDA intends to accept requests for participation in the IMDRF's Regulated Product Submission, ToC Implementation Pilot for 12 months, from September 2015 through September 2016. This Pilot program may be extended as resources and needs allow. IV. 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.FDAC. 3501-3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120 and the collections of information in 21 CFR part 814, subparts A through E have been approved under OMB control number 0910-0231. V. References The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. (FDA has verified all the Web site addresses in this reference section, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 1. IMDRF Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC) Final Document, http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140630-rps-nivd-toc.pdf. 2. IMDRF In Vitro Diagnostic Device Market Authorization Table of Contents (IVD MA ToC) Final Document, http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140630-rps-ivd-toc.pdf. 3. FDA/IMDRF Documents, Regulated Product Submission (RPS) Work Item, http://www.fda.gov/MedicalDevices/InternationalPrograms/IMDRF/ucm417027.htm. 4. IMDRF Table of Contents (ToC) Pilot Plan, http://www.imdrf.org/docs/imdrf/final/procedural/imdrf-proc-150708-toc-pilot-plan.pdf. 5. FDA's eCopy Program for Medical Device Submissions Final Guidance, October 10, 2013, http://www.fda.gov/downloads/ MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ [[Page 50295]] UCM313794.pdf. 6. FDA's Refuse to Accept Policy for 510(k)s Final Guidance, December 31, 2012, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM315014.pdf. Dated: August 13, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-20430 Filed 8-18-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices 50293
Legislation, and Analysis, Food and submit a request to participate. The of samples involving submission to
Drug Administration, 10903 New Pilot project will accept submissions more than one jurisdiction.
Hampshire Ave., Bldg. 32, Rm. 3330, with the ToC structure starting Furthermore, there were no specific
Silver Spring, MD 20993–0002, 301– September 2015 through September guidelines regarding the means of
796–9115. 2016. building a submission in a non-standard
SUPPLEMENTARY INFORMATION: In FR Doc. FOR FURTHER INFORMATION CONTACT: Jodi implementation. Additional IMDRF
2014–13290, appearing on page 32964, Hope N. Anderson, Center for Devices testing is considered necessary to both
in the Federal Register of Monday, June and Radiological Health, Food and Drug evaluate the ToC structures using real
9, 2014, the following correction is Administration, 10903 New Hampshire regulatory submissions and also
made: Ave., Bldg. 66, Rm. 1520, Silver Spring, evaluate the ToC structure from an
On page 32964, in the second column, industry perspective.
MD 20993, 301–796–9299,
in the headings section of the document, Jodi.Anderson@fda.hhs.gov. II. CDRH Participation in IMDRF
[Docket No. FDA–2014–N–0736]’’ is SUPPLEMENTARY INFORMATION: Regulated Product Submission Table of
corrected to read ‘‘FDA–2015–N–2781’’. Contents (ToC) Implementation Pilot
Please be aware that this new docket I. Background
is no longer open for comment. FDA’s participation in the IMDRF
The IMDRF was conceived in RPS ToC Implementation Pilot will
Dated: August 12, 2015. February 2011 as a forum to discuss provide both local and international
Jill Hartzler Warner, future directions in medical device benefits for FDA, as it will provide FDA
Associate Commissioner for Special Medical regulatory harmonization. It is a feedback into decisions regarding the
Programs. voluntary group of medical device ToC’s suitability.
[FR Doc. 2015–20397 Filed 8–18–15; 8:45 am] regulators from around the world who CDRH is participating in the Pilot. In
BILLING CODE 4164–01–P
have come together to build on the doing so, CDRH will receive premarket
strong foundational work of the Global submissions from the medical device
Harmonization Task Force. The Forum regulated industry using the IMDRF ToC
DEPARTMENT OF HEALTH AND aims to accelerate international medical and FDA Regional Classification
HUMAN SERVICES device regulatory harmonization and Matrices. Applications are to be real
convergence. regulatory submissions—either PMAs or
Food and Drug Administration The Regulated Product Submission 510(k) applications—that will result in
(RPS) proposal was endorsed as a new regulatory decisions by CDRH. PMAs
[Docket No. FDA–2015–N–2458]
work item by IMDRF at its 2012 exclude combination products and
Center for Devices and Radiological inaugural meeting in Singapore. The bundled submissions. The 510(k)s
Health Participation in International Work Group, consisting of regulatory exclude special, abbreviated, and third-
Medical Device Regulators Forum, authorities from the United States, party submissions, as well as
Regulated Product Submission, Table European Union (EU), Australia, Brazil, combination products, bundled
of Contents Pilot Program Japan, China, and Canada, created a submissions, and amendments after a
comprehensive Table of Contents for final decision. Pilot participation
AGENCY: Food and Drug Administration, Non-In Vitro Diagnostics (nIVD) and requires that an application submitted
HHS. also for IVD Marketing Authorizations, to FDA also be submitted sequentially
ACTION: Notice. which were formalized in August 2014. or simultaneously to at least one
The ToC provides a comprehensive additional participating IMDRF region.
SUMMARY: The Food and Drug submission structure that can be used as Currently the participating regulating
Administration’s (FDA) Center for a harmonized international electronic authorities are Australia (Therapeutic
Devices and Radiological Health submission format while minimizing Goods Administration), Brazil
(CDRH), Offices of Device Evaluation regional divergences and indicating (ANVISA), Canada (Health Canada),
(ODE) and In Vitro Diagnostics and where regional variation exists. This China (China Food and Drug
Radiation (OIR) are announcing their document is intended to provide Administration), and the European
participation in the International guidance regarding the location of Union (Notified Bodies).
Medical Device Regulators Forum’s submission elements. These documents The Pilot is described in greater detail
(IMDRF) Regulated Product Submission can be found on IMDRF’s Web site in the IMDRF/RPS WG/N26
Table of Contents Pilot Program. (Refs. 1 and 2). Informational Document ‘‘IMDRF Table
Participation in the Pilot is voluntary This document is intended to work of Contents (ToC) Pilot Plan’’ (Ref. 4).
and open to applicants who submit together with a regional classification The Regulators participating in this
premarket approval (PMA) applications matrix, a separate document created for Pilot intend to use submissions only for
or premarket notification (510(k)) to each participating jurisdiction. The the requested regulatory activity and
either ODE or OIR. The Pilot project is classification matrix defines whether a objectives of this Pilot. Any submissions
intended to provide industry, IMDRF, heading is required, not required, generated in relation to this testing will
and CDRH staff the opportunity to optional, conditionally required, etc., not be distributed to other
evaluate the Table of Contents structure for the given submission type. FDA’s manufacturers or other regulators.
and to receive input from industry Classification Matrices can be found on Industry participants should share any
participants. Participants will be asked FDA’s Web site (Ref. 3). submission content directly with the
to submit their submissions The ToC Work Group has previously appropriate regulators through the
electronically using IMDRF’s Table of
tkelley on DSK3SPTVN1PROD with NOTICES
conducted Pilots for both of the ToC official regulatory processes in place—
Contents (ToC) format. structures, using historical submissions. i.e., submission content will be shared
DATES: The IMDRF is seeking interest These Pilots provided valuable feedback across regulators directly by regulated
for participation in the voluntary regarding the ToC structure and industry.
IMDRF Regulated Product Submission, completeness; however, there were Feedback provided on the ToC
Table of Contents Pilot Program. See limitations to using historical structure, experience developing
section II.A. for instructions on how to submissions and also a limited number regulatory submissions, or suggestions
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![Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices 50295
UCM313794.pdf. Therefore, you should always check the disabilities or special needs. If you
6. FDA’s Refuse to Accept Policy for 510(k)s Agency’s Web site at http:// require special accommodations due to
Final Guidance, December 31, 2012, www.fda.gov/AdvisoryCommittees/ a disability, please contact Philip
http://www.fda.gov/downloads/ default.htm and scroll down to the Bautista at least 7 days in advance of the
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
appropriate advisory committee meeting meeting.
UCM315014.pdf. link, or call the advisory committee FDA is committed to the orderly
information line to learn about possible conduct of its advisory committee
Dated: August 13, 2015. modifications before coming to the meetings. Please visit our Web site at
Leslie Kux, meeting. http://www.fda.gov/
Associate Commissioner for Policy. Agenda: The committee will discuss AdvisoryCommittees/
[FR Doc. 2015–20430 Filed 8–18–15; 8:45 am] new drug application (NDA) 207988, AboutAdvisoryCommittees/
BILLING CODE 4164–01–P lesinurad oral tablets, submitted by ucm111462.htm for procedures on
Ardea Biosciences, Inc., for the public conduct during advisory
treatment of hyperuricemia associated committee meetings.
DEPARTMENT OF HEALTH AND with gout, in combination with a Notice of this meeting is given under
HUMAN SERVICES xanthine oxidase inhibitor. the Federal Advisory Committee Act (5
FDA intends to make background U.S.C. app. 2).
Food and Drug Administration material available to the public no later Dated: August 12, 2015.
[Docket No. FDA–2015–N–0001] than 2 business days before the meeting. Jill Hartzler Warner,
If FDA is unable to post the background
Associate Commissioner for Special Medical
Arthritis Advisory Committee; Notice material on its Web site prior to the Programs.
of Meeting meeting, the background material will
[FR Doc. 2015–20398 Filed 8–18–15; 8:45 am]
be made publicly available at the
AGENCY: Food and Drug Administration, location of the advisory committee BILLING CODE 4164–01–P
HHS. meeting, and the background material
ACTION: Notice. will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND
the meeting. Background material is HUMAN SERVICES
This notice announces a forthcoming available at http://www.fda.gov/
meeting of a public advisory committee AdvisoryCommittees/Calendar/ Food and Drug Administration
of the Food and Drug Administration default.htm. Scroll down to the
(FDA). The meeting will be open to the appropriate advisory committee meeting [Docket No. FDA–2015–N–2817]
public. link.
Name of Committee: Arthritis Medical Devices; Export Certificates;
Procedure: Interested persons may
Advisory Committee. Food and Drug Administration Export
present data, information, or views,
General Function of the Committee: Reform and Enhancement Act of 1996;
orally or in writing, on issues pending
To provide advice and Certification Fees
before the committee. Written
recommendations to the Agency on submissions may be made to the contact AGENCY: Food and Drug Administration,
FDA’s regulatory issues. person on or before October 8, 2015. HHS.
Date and Time: The meeting will be Oral presentations from the public will ACTION: Notice.
held on October 23, 2015, from 8 a.m. be scheduled between approximately 1
to 5 p.m. p.m. and 2 p.m. Those individuals SUMMARY: The Food and Drug
Location: FDA White Oak Campus, interested in making formal oral Administration (FDA) is announcing the
10903 New Hampshire Ave., Bldg. 31 presentations should notify the contact revised fees the Agency will assess for
Conference Center, the Great Room (Rm. person and submit a brief statement of issuing export certificates for devices.
1503), Silver Spring, MD 20993–0002. the general nature of the evidence or The FDA Export Reform and
Answers to commonly asked questions arguments they wish to present, the Enhancement Act of 1996 (EREA)
including information regarding special names and addresses of proposed provides that any person who exports a
accommodations due to a disability, participants, and an indication of the device may request FDA certify in
visitor parking, and transportation may approximate time requested to make writing that the exported device meets
be accessed at: http://www.fda.gov/ their presentation on or before certain specified requirements. It further
AdvisoryCommittees/ September 30, 2015. Time allotted for provides that FDA shall issue such a
AboutAdvisoryCommittees/ each presentation may be limited. If the certification within 20 days of the
ucm408555.htm. number of registrants requesting to receipt of a request for such certification
Contact Person: Philip Bautista, speak is greater than can be reasonably and that FDA may charge up to $175 for
Center for Drug Evaluation and accommodated during the scheduled each certification that is issued within
Research, Food and Drug open public hearing session, FDA may the 20 days. Since February 2003, FDA’s
Administration, 10903 New Hampshire conduct a lottery to determine the costs to process the device certificates
Ave., Bldg. 31, Rm. 2417, Silver Spring, speakers for the scheduled open public have increased; however, the export
MD 20993–0002, 301–796–9001, FAX: hearing session. The contact person will certificate fee for subsequent certificates
301–847–8533, email: AAC@ notify interested persons regarding their has not changed. Because of the
fda.hhs.gov, or FDA Advisory request to speak by October 1, 2015. increase, FDA is raising the fees for
Committee Information Line, 1–800– Persons attending FDA’s advisory subsequent certificates, from the current
tkelley on DSK3SPTVN1PROD with NOTICES
741–8138 (301–443–0572 in the committee meetings are advised that the fee of $15 to $85, and revising the
Washington, DC area). A notice in the Agency is not responsible for providing formula used to calculate the number of
Federal Register about last minute access to electrical outlets. original and subsequent device export
modifications that impact a previously FDA welcomes the attendance of the certificates issued. These changes are
announced advisory committee meeting public at its advisory committee necessary to ensure that the program
cannot always be published quickly meetings and will make every effort to remains self-sustaining and to cover
enough to provide timely notice. accommodate persons with physical FDA’s increased costs, which are
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Document Created: 2015-12-15 11:58:21
Document Modified: 2015-12-15 11:58:21
| 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 IMDRF is seeking interest for participation in the voluntary IMDRF Regulated Product Submission, Table of Contents Pilot Program. See section II.A. for instructions on how to submit a request to participate. The Pilot project will accept submissions with the ToC structure starting September 2015 through September 2016. | |
| Contact | Jodi Hope N. Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1520, Silver Spring, MD 20993, 301- 796-9299, [email protected] | |
| FR Citation | 80 FR 50293 |
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