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)
Food and Drug Administration
Federal Register Volume 80, Issue 70 (April 13, 2015)
| Page Range | 19669-19671 | |
| FR Document | 2015-08364 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices 19669
In recent years, many important INFORMATION CONTACT) at least 7 days DEPARTMENT OF HEALTH AND
initiatives have been undertaken by before the meeting. HUMAN SERVICES
regulatory authorities and industry
associations to promote international B. Requests for Oral Presentations Food and Drug Administration
harmonization of regulatory Interested persons may present data, [Docket No. FDA–2014–D–0363]
requirements. FDA has participated in information, or views orally or in
many meetings designed to enhance writing on issues pending at the public Expedited Access for Premarket
harmonization and is committed to Approval and De Novo Medical
meeting. Public oral presentations will
seeking scientifically based harmonized Devices Intended for Unmet Medical
be scheduled between approximately
technical procedures for pharmaceutical Need for Life Threatening or
3:30 p.m. and 4 p.m. Time allotted for
development. One of the goals of Irreversibly Debilitating Diseases or
harmonization is to identify and then oral presentations may be limited to 5
minutes. Those desiring to make oral Conditions; Guidance for Industry and
reduce differences in technical Food and Drug Administration Staff;
requirements for medical product presentations should notify Tracy Porter
(see FOR FURTHER INFORMATION CONTACT) Availability
development among regulatory
Agencies. ICH was organized to provide by May 11, 2015, and submit a brief AGENCY: Food and Drug Administration,
an opportunity for harmonization statement of the general nature of the HHS.
initiatives to be developed with input evidence or arguments they wish to ACTION: Notice.
from both regulatory and industry present; the names and addresses,
representatives. Members of the ICH telephone number, fax, and email of SUMMARY: The Food and Drug
Steering Committee include the proposed participants; and an Administration (FDA or the Agency) is
European Union; the European indication of the approximate time announcing the availability of the
Federation of Pharmaceutical Industries requested to make their presentation. guidance entitled ‘‘Expedited Access for
Associations; the Japanese Ministry of Premarket Approval and De Novo
The agenda for the public meeting
Health, Labor, and Welfare; the Japanese Medical Devices Intended for Unmet
will be made available on the Internet Medical Need for Life Threatening or
Pharmaceutical Manufacturers at http://www.fda.gov/Drugs/
Association; FDA; the Pharmaceutical Irreversibly Debilitating Diseases or
NewsEvents/ucm439475.htm. Conditions.’’ This guidance outlines
Research and Manufacturers of America;
Health Canada; Swissmedic; and the III. Comments FDA’s new, voluntary program for
World Health Organization (as an certain medical devices that
Observer). The ICH process has Interested persons may submit either demonstrate the potential to address
achieved significant harmonization of electronic or written comments to the unmet medical needs for life threatening
the technical requirements for the public docket (see ADDRESSES) by June or irreversibly debilitating diseases or
approval of pharmaceuticals for human 14, 2015. It is only necessary to send conditions and that are subject to
use in the ICH regions over the past two one set of comments. Identify comments premarket approval (PMA) applications
decades. with the docket number found in or de novo classifications. FDA believes
brackets in the heading of this that the Expedited Access Pathway
The current ICH process and structure
document. Received comments may be (EAP) program will help patients have
can be found at the following Web site:
seen in the Division of Dockets more timely access to these medical
http://www.ich.org. (FDA has verified
Management between 9 a.m. and 4 p.m., devices by expediting their
the Web site addresses in this
Monday through Friday, and will be development, assessment, and review,
document, but FDA is not responsible
posted to the docket at http:// while preserving the statutory standard
for any subsequent changes to the Web
www.regulations.gov. of reasonable assurance of safety and
sites after this document publishes in
effectiveness for premarket approval,
the Federal Register.)
IV. Transcripts consistent with the Agency’s mission to
II. Meeting Attendance and protect and promote public health. The
Participation Please be advised that as soon as a document also discusses how the EAP
meeting transcript is available, FDA will program approaches the balance of
A. Registration post it at http://www.fda.gov/Drugs/ premarket and postmarket data
If you wish to attend the meeting, NewsEvents/ucm439475.htm. collection and incorporates a benefit-
visit https://www.eventbrite.com/e/ Dated: April 7, 2015. risk framework. The EAP program will
international-conference-on- Leslie Kux,
become effective April 15, 2015.
harmonization-regional-public-meeting- DATES: Submit either electronic or
Associate Commissioner for Policy.
tickets-16183519342. Please register for written comments on this guidance at
[FR Doc. 2015–08359 Filed 4–10–15; 8:45 am]
the meeting by May 11, 2015. Seating any time. General comments on Agency
may be limited, so early registration is BILLING CODE 4164–01–P
guidance documents are welcome at any
recommended. Registration is free and time.
will be on a first-come, first-served ADDRESSES: An electronic copy of the
basis. However, FDA may limit the guidance document is available for
number of participants from each download from the Internet. See the
organization based on space limitations.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION section for
Registrants will receive confirmation information on electronic access to the
once they have been accepted. Onsite guidance. Submit written requests for a
registration on the day of the meetings single hard copy of the guidance
will be based on space availability. document entitled ‘‘Expedited Access
If you need special accommodations for Premarket Approval and De Novo
because of a disability, please contact Medical Devices Intended for Unmet
Tracy Porter (see FOR FURTHER Medical Need for Life Threatening or
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![Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices 19671
approved under OMB control number Silver Spring, MD 20993, 301–796– FDA determine the product’s regulatory
0910–0756. 7900. review period.
FDA has determined that the
V. Comments SUPPLEMENTARY INFORMATION: The Drug applicable regulatory review period for
Interested persons may submit either Price Competition and Patent Term ELVITEGRAVIR (as a component of
electronic comments regarding this Restoration Act of 1984 (Pub. L. 98–417) STRIBILD) is 2,666 days. Of this time,
document to http://www.regulations.gov and the Generic Animal Drug and Patent 2,360 days occurred during the testing
or written comments to the Division of Term Restoration Act (Pub. L. 100–670) phase of the regulatory review period,
Dockets Management (see ADDRESSES). It generally provide that a patent may be while 306 days occurred during the
is only necessary to send one set of extended for a period of up to 5 years approval phase. These periods of time
comments. Identify comments with the so long as the patented item (human were derived from the following dates:
docket number found in brackets in the drug product, animal drug product, 1. The date an exemption under
heading of this document. Received medical device, food additive, or color section 505(i) of the Federal Food, Drug,
comments may be seen in the Division additive) was subject to regulatory and Cosmetic Act (the FD&C Act) (21
of Dockets Management between 9 a.m. review by FDA before the item was U.S.C. 355(i)) became effective: May 12,
and 4 p.m., Monday through Friday, and marketed. Under these acts, a product’s 2005. The applicant claims May 18,
will be posted to the docket at http:// regulatory review period forms the basis 2005, as the date the investigational new
www.regulations.gov. for determining the amount of extension drug application (IND) for
an applicant may receive. ELVITEGRAVIR became effective.
Dated: April 7, 2015.
A regulatory review period consists of However, FDA records indicate that the
Leslie Kux, IND effective date was May 12, 2005,
Associate Commissioner for Policy.
two periods of time: A testing phase and
an approval phase. For human drug which was the date the IND sponsor was
[FR Doc. 2015–08364 Filed 4–10–15; 8:45 am] notified that clinical trials may proceed.
products, the testing phase begins when
BILLING CODE 4164–01–P
the exemption to permit the clinical 2. The date the application was
investigations of the drug becomes initially submitted with respect to the
effective and runs until the approval human drug product under section
DEPARTMENT OF HEALTH AND 505(b) of the FD&C Act: October 27,
phase begins. The approval phase starts
HUMAN SERVICES 2011. The applicant claims October 26,
with the initial submission of an
application to market the human drug 2011, as the date the new drug
Food and Drug Administration application (NDA) for STRIBILD (NDA
product and continues until FDA grants
[Docket No. FDA–2013–E–0475] permission to market the drug product. 203–100) was initially submitted.
Although only a portion of a regulatory However, FDA records indicate that
Determination of Regulatory Review NDA 203–100 was submitted on
review period may count toward the
Period for Purposes of Patent October 27, 2011.
actual amount of extension that the
Extension; ELVITEGRAVIR 3. The date the application was
Director of USPTO may award (for
approved: August 27, 2012. FDA has
AGENCY: Food and Drug Administration, example, half the testing phase must be
verified the applicant’s claim that NDA
HHS. subtracted as well as any time that may
203–100 was approved on August 27,
ACTION: Notice. have occurred before the patent was
2012.
issued), FDA’s determination of the This determination of the regulatory
SUMMARY: The Food and Drug length of a regulatory review period for review period establishes the maximum
Administration (FDA) has determined a human drug product will include all potential length of a patent extension.
the regulatory review period for of the testing phase and approval phase However, the USPTO applies several
ELVITEGRAVIR (as a component of as specified in 35 U.S.C. 156(g)(1)(B). statutory limitations in its calculations
STRIBILD) and is publishing this notice FDA has approved for marketing the of the actual period for patent extension.
of that determination as required by human drug product ELVITEGRAVIR In its application for patent extension,
law. FDA has made the determination (as a component of STRIBILD this applicant seeks 1,021 days of patent
because of the submission of an (cobicistat/emtricitabine/ term extension.
application to the Director of the U.S. ELVITEGRAVIR/tenofovir disoproxil Anyone with knowledge that any of
Patent and Trademark Office (USPTO), fumarate)). STRIBILD is indicated as a the dates as published are incorrect may
Department of Commerce, for the complete regimen for the treatment of submit to the Division of Dockets
extension of a patent which claims that HIV–1 infection in adults who are Management (see ADDRESSES) either
human drug product. antiretroviral treatment-naive. electronic or written comments and ask
ADDRESSES: Submit electronic Subsequent to this approval, the USPTO for a redetermination by June 12, 2015.
comments to http:// received a patent term restoration Furthermore, any interested person may
www.regulations.gov. Submit written application for ELVITEGRAVIR (as a petition FDA for a determination
petitions (two copies are required) and component of STRIBILD) (U.S. Patent regarding whether the applicant for
written comments to the Division of No. 7,176,220) from Japan Tobacco Inc., extension acted with due diligence
Dockets Management (HFA–305), Food and the USPTO requested FDA’s during the regulatory review period by
and Drug Administration, 5630 Fishers assistance in determining this patent’s October 13, 2015. To meet its burden,
Lane, Rm. 1061, Rockville, MD 20852. eligibility for patent term restoration. In the petition must contain sufficient facts
Submit petitions electronically to http://
mstockstill on DSK4VPTVN1PROD with NOTICES
a letter dated July 10, 2013, FDA to merit an FDA investigation. (See H.
www.regulations.gov at Docket No. advised the USPTO that this human Rept. 857, part 1, 98th Cong., 2d sess.,
FDA–2013–S–0610. drug product had undergone a pp. 41–42, 1984.) Petitions should be in
FOR FURTHER INFORMATION CONTACT: regulatory review period and that the the format specified in 21 CFR 10.30.
Beverly Friedman, Office of approval of STRIBILD represented the Interested persons may submit to the
Management, Food and Drug first permitted commercial marketing or Division of Dockets Management (see
Administration, 10001 New Hampshire use of the ELVITEGRAVIR product. ADDRESSES) electronic or written
Ave., Hillandale Campus, Rm. 3180, Thereafter, the USPTO requested that comments and written or electronic
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Document Created: 2015-12-18 11:22:28
Document Modified: 2015-12-18 11:22:28
| 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 | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| 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. | |
| FR Citation | 80 FR 19669 |
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