[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Pages 22691-22692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09189]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0363]


Expedited Access for Premarket Approval Medical Devices Intended 
for Unmet Medical Need for Life Threatening or Irreversibly 
Debilitating Disease or Conditions; Draft Guidance for Industry and 
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of the draft guidance entitled ``Expedited 
Access for Premarket Approval Medical Devices Intended for Unmet 
Medical Need for Life Threatening or Irreversibly Debilitating Disease 
or Conditions.'' This draft guidance outlines FDA's proposal for a new, 
voluntary program for certain medical devices that demonstrate the 
potential to address unmet medical needs for life threatening or 
irreversibly debilitating diseases or conditions and are subject to 
premarket approval applications (PMA). FDA believes that the Expedited 
Access PMA (EAP) program will help patients have more timely access to 
these medical devices by expediting their development, assessment, and 
review, while preserving the statutory standard of reasonable assurance 
of safety and effectiveness for premarket approval, consistent with the 
Agency's mission to protect and promote public health. The document 
also discusses how the EAP program approaches the balance of premarket 
and postmarket data collection and incorporates a benefit-risk 
framework. This draft guidance is not final nor is it in effect at this 
time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 22, 2014.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Expedited Access for Premarket Approval Medical Devices Intended for 
Unmet Medical Need for

[[Page 22692]]

Life Threatening or Irreversibly Debilitating Disease or Conditions'' 
to the Office of the Center Director, Guidance and Policy Development, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5431, Silver 
Spring, MD 20993-0002; or the Office of Communication, Outreach and 
Development (HFM-40), Center for Biologics Evaluation and Research, 
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in 
processing your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Office of the Center Director, Center 
for Devices and Radiological Health (CDRH), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5431, Silver 
Spring, MD 20993-0002, 301-796-5900; or Stephen Ripley, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA's proposed EAP program contains features from CDRH's Innovation 
Pathway, piloted in 2011 to facilitate the development and expedite the 
review of breakthrough technologies. In addition, the proposed EAP 
program is based in part on FDA's experience with the Center for Drug 
Evaluation and Research and Center for Biologics Evaluation and 
Research programs that are intended to facilitate and expedite 
development and review of new drugs to address unmet medical needs in 
the treatment of serious or life-threatening conditions (``FDA drug 
expedited programs''). However, while the EAP program incorporates some 
features of the FDA drug expedited programs, it is a separate and 
distinct program tailored to devices and intended to further speed the 
availability of certain safe and effective devices that address unmet 
public health needs.
    As part of the EAP program, FDA intends to provide more interactive 
communications during device development and more interactive review of 
Investigational Device Exemption applications and PMA applications. 
This includes working with the sponsor to create a data development 
plan specific to the device, which would outline all data the sponsor 
intends to collect in support of device approval, and identifying what 
data would be collected premarket and postmarket. In addition, FDA 
intends to work interactively with the sponsor within the benefit-risk 
framework discussed in the FDA guidance, ``Factors to Consider When 
Making Benefit-Risk Determinations in Medical Device Premarket 
Approvals and De Novo Classifications,'' issued on March 28, 2012, and 
in accordance with statutory and regulatory requirements, to determine 
whether certain data may be collected postmarket rather than premarket. 
This guidance details the EAP process which will only be utilized at 
the request of the sponsor and with FDA's agreement.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
another draft guidance entitled ``Balancing Premarket and Postmarket 
Data Collection for Devices Subject to Premarket Approval,'' which also 
addresses the role of postmarket data and the benefit-risk framework to 
support premarket approval, while still meeting the statutory standard 
of reasonable assurance of safety and effectiveness.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on expedited 
access for premarket approval medical devices intended for unmet 
medical need for life threatening or irreversibly debilitating diseases 
or conditions. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``Expedited Access for Premarket 
Approval Medical Devices Intended for Unmet Medical Need for Life 
Threatening or Irreversibly Debilitating Disease or Conditions,'' may 
send an email request to [email protected] to receive an 
electronic copy of the document. Please use the document number 1400007 
to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance 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 812 have been approved under 
OMB control number 0910-0078, the collections of information in 21 CFR 
part 814 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 21 
CFR part 822 have been approved under OMB control number 0910-0449.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09189 Filed 4-22-14; 8:45 am]
BILLING CODE 4160-01-P