[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)]
[Notices]
[Pages 50293-50295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20430]


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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.

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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