80 FR 19669 - Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions; Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 70 (April 13, 2015)

The Food and Drug Administration (FDA or the Agency) is announcing the availability of the guidance entitled ``Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.'' This guidance outlines FDA's 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 that are subject to premarket approval (PMA) applications or de novo classifications. FDA believes that the Expedited Access Pathway (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. The EAP program will become effective April 15, 2015.

[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Notices]
[Pages 19669-19671]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08364]


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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 and De Novo Medical 
Devices Intended for Unmet Medical Need for Life Threatening or 
Irreversibly Debilitating Diseases or Conditions; 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 guidance entitled ``Expedited Access 
for Premarket Approval and De Novo Medical Devices Intended for Unmet 
Medical Need for Life Threatening or Irreversibly Debilitating Diseases 
or Conditions.'' This guidance outlines FDA's 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 that are subject to premarket approval (PMA) 
applications or de novo classifications. FDA believes that the 
Expedited Access Pathway (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. The EAP program will become 
effective April 15, 2015.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

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 guidance document entitled 
``Expedited Access for Premarket Approval and De Novo Medical Devices 
Intended for Unmet Medical Need for Life Threatening or

[[Page 19670]]

Irreversibly Debilitating Diseases 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 to 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request.
    Submit electronic comments on the 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: Aaron Josephson, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5449, Silver Spring, MD 20993-0002, 301-
796-5178; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's EAP program contains features from the Center for Devices and 
Radiological Health's (CDRH's) Innovation Pathway, piloted in 2011 to 
facilitate the development and expedite the review of breakthrough 
technologies. In addition, the 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, PMA applications, and 
requests for de novo review. 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 in the postmarket setting rather than in the premarket 
setting for devices subject to PMAs. This guidance details the EAP 
process, which will only be utilized at the request of the sponsor and 
with FDA's agreement.
    At the time of this document's publication, FDA does not know 
whether the EAP program will require a significant increase in 
resources. FDA will devote as many resources to EAP as possible without 
adversely impacting our ability to meet our Medical Device User Fee Act 
commitments. Our experience with the Innovation Pathway showed that 
early and more extensive interactions with sponsors can consume a 
significant amount of manager and staff time. FDA plans to closely 
monitor implementation of EAP to determine whether we have sufficient 
resources to effectively implement the program.
    A draft of this guidance was made available in the Federal Register 
on April 23, 2014, and the comment period closed July 22, 2014. Changes 
between the draft and final versions of this guidance include expanding 
the scope to include de novo requests, an increased focus on patient 
benefits, a clarification of how FDA will allocate resources to the EAP 
program, and a clarified explanation of the EAP designation process. 
FDA also provided more examples to help industry better understand in 
which cases EAP may be the most appropriate pathway to device approval. 
The final guidance also recognizes the potential for use of registry 
data to satisfy post-approval study requirements and adds an evaluation 
mechanism for the EAP program.
    The EAP program will become effective April 15, 2015.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on the Expedited Access PMA program. 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 guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all CDRH 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 from CBER at 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 
Diseases 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 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, subparts A through E, have been approved under OMB control 
number 0910-0231; the collections of information in 21 CFR part 814, 
subpart H, have been approved under OMB control number 0910-0332; the 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073; the collections of information in 21 CFR 
part 822 have been approved under OMB control number 0910-0449; and the 
collections of information regarding ``Requests for Feedback on Medical 
Device Submissions'' have been

[[Page 19671]]

approved under OMB control number 0910-0756.

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 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08364 Filed 4-10-15; 8:45 am]
 BILLING CODE 4164-01-P