82 FR 49373 - Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 205 (October 25, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 205 (October 25, 2017)
| Page Range | 49373-49375 | |
| FR Document | 2017-23195 |
[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)] [Notices] [Pages 49373-49375] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23195] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5966] Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff.'' This guidance document describes policies that FDA intends to use to implement the new Breakthrough Devices Program, established by the 21st Century Cures Act (Cures Act). The Breakthrough Devices Program supersedes and combines elements from FDA's Expedited Access Pathway (EAP), which was intended to facilitate the development and expedite review of breakthrough technologies, as well as the Priority Review Program, which implemented statutory criteria for granting priority review to premarket approval applications (PMAs) and applied those criteria to other types of premarket submissions for medical devices. This draft guidance clarifies certain principles and features of the new program, the designation criteria for Breakthrough Devices, the designation request review process, the process for withdrawing from the program, as well as the recommended information device manufacturers should provide in their designation request for entrance into the program. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by December 26, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. [[Page 49374]] If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-D-5966 for ``Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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 ``Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff'' 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, 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. FOR FURTHER INFORMATION CONTACT: Erin Cutts, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1625, Silver Spring, MD 20993-0002, 301-796-6307; 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, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is issuing this draft guidance to describe policies that FDA intends to use to implement section 515B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e-3, as created by section 3051 of the Cures Act (Pub. L. 114-255) and section 901 of the FDA Reauthorization Act of 2017 (Pub. L. 115-52) (the ``Breakthrough Devices Program''). The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, clearance of a premarket notification (510(k)), and marketing authorization via the De Novo classification process, consistent with the Agency's statutory mission to protect and promote public health. No later than 1 year after the date of enactment of the Cures Act, FDA is required to issue this draft guidance, which sets forth the process by which a person may seek a Breakthrough Device designation, provides a template for designation requests, identifies the criteria that FDA will use in evaluating designation requests, and identifies the criteria and processes FDA will use to assign and train a team of staff to review breakthrough devices after designation has been granted. See section 515B(f) of the FD&C Act. As part of the Breakthrough Devices Program, FDA intends to provide interactive and timely communication with the sponsor during development and throughout the review process for devices designated as Breakthrough Devices under section 515B(d)(1) of the FD&C Act and grant priority to the review of associated Q-submissions, investigational device exemption (IDE) applications, PMAs, De Novo classification requests, and premarket notifications (510(k)s). In addition, for Breakthrough Devices subject to PMA, FDA may consider the amount of data that may be collected in the postmarket setting, rather than premarket, and the level of acceptable uncertainty in the benefit-risk profile at the time of approval. Getting the right balance between premarket and postmarket data collection--specifically, where appropriate, a greater reliance on postmarket collection--can reduce the extent of premarket data submission. Collectively, these and the other principles of the program described in this draft guidance are intended to support a least-burdensome approach for expediting patient access to Breakthrough Devices. The Breakthrough Devices Program supersedes the EAP, which launched in 2015. The Breakthrough Devices Program contains features of the EAP as well as the Innovation Pathway (first piloted in 2011), both of which were intended to facilitate the development [[Page 49375]] and expedite the review of breakthrough technologies. The Breakthrough Devices Program also supersedes the Priority Review Program, which implemented statutory criteria for granting priority review to PMA submissions for medical devices, applied those criteria to other types of premarket submissions for medical devices, and included standard procedures to achieve an efficient priority review process. 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 current thinking of FDA on ``Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff.'' It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download an electronic copy of ``Breakthrough Devices Program'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1833 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 807, subpart E have been approved under OMB control number 0910-0120; the collections of information for De Novo classification requests have been approved under OMB control number 0910-0844; 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 approved under OMB control number 0910- 0756. Dated: October 20, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-23195 Filed 10-24-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49373
level of risk. Clinically relevant DDIs guidances will be developed to cover announcing the availability of the draft
between an investigational drug and other types of DDIs. In addition, a draft guidance entitled ‘‘Breakthrough
other drugs should therefore: (1) Be guidance specific to Section 7 (Drug Devices Program; Draft Guidance for
defined during drug development as Interactions) labeling will be developed Industry and Food and Drug
part of an adequate assessment of the to delineate the communication of DDI Administration Staff.’’ This guidance
drug’s overall benefit/risk profile; (2) be information in labeling. document describes policies that FDA
known at the time of the drug’s These two draft guidances are being intends to use to implement the new
approval; and (3) be communicated in issued consistent with FDA’s good Breakthrough Devices Program,
labeling. These two draft guidances are guidance practices regulation (21 CFR established by the 21st Century Cures
intended to assist drug developers in the 10.115). These draft guidances, when Act (Cures Act). The Breakthrough
planning and evaluation of DDI finalized, will represent the Agency’s Devices Program supersedes and
potential during drug development. In current thinking on ‘‘In Vitro combines elements from FDA’s
particular, the in vitro DDI guidance Metabolism- and Transporter-Mediated Expedited Access Pathway (EAP),
focuses on in vitro experimental Drug-Drug Interaction Studies’’ and which was intended to facilitate the
approaches for evaluating metabolizing ‘‘Clinical Drug Interaction Studies— development and expedite review of
enzyme- and transporter-based drug Study Design, Data Analysis, and breakthrough technologies, as well as
interaction potential, and how to Clinical Implications.’’ It does not the Priority Review Program, which
extrapolate in vitro data to decide on the establish any rights for any person and implemented statutory criteria for
need for clinical DDI studies. The is not binding on FDA or the public. granting priority review to premarket
appendix of the in vitro DDI guidance You can use an alternative approach if approval applications (PMAs) and
includes considerations in the choice of it satisfies the requirements of the applied those criteria to other types of
in vitro experimental systems, key applicable statutes and regulations. premarket submissions for medical
issues regarding in vitro experimental These guidances are not subject to devices. This draft guidance clarifies
conditions, and a more detailed Executive Order 12866. certain principles and features of the
explanation of model-based DDI new program, the designation criteria
prediction strategies. If in vitro II. Paperwork Reduction Act of 1995
for Breakthrough Devices, the
assessments indicate the need to These draft guidances refer to designation request review process, the
conduct clinical DDI studies, sponsors previously approved collections of process for withdrawing from the
should consult the related clinical DDI information found in FDA regulations. program, as well as the recommended
guidance. The clinical DDI guidance These collections of information are information device manufacturers
focuses on clinical studies that evaluate subject to review by the Office of should provide in their designation
DDIs that alter a drug’s Management and Budget (OMB) under request for entrance into the program.
pharmacokinetics by modulating the the Paperwork Reduction Act of 1995 This draft guidance is not final nor is it
effects of drug metabolizing enzymes (44 U.S.C. 3501–3520). The collections in effect at this time.
and/or transporters and advises of information in 21 CFR 314.50(d) have
sponsors on the timing and design of the been approved under OMB control DATES: Submit either electronic or
clinical studies, interpretation of the number 0910–0001. written comments on the draft guidance
results, and options for DDI by December 26, 2017 to ensure that the
management in patients. Together, the III. Electronic Access Agency considers your comment on this
two draft guidances describe a Persons with access to the internet draft guidance before it begins work on
systematic, risk-based approach to may obtain the draft guidance at either the final version of the guidance.
evaluation and communication of DDIs. https://www.fda.gov/Drugs/Guidance ADDRESSES: You may submit comments
In the Federal Register of February ComplianceRegulatoryInformation/ on any guidance at any time as follows:
21, 2012 (77 FR 9946), FDA announced Guidances/default.htm or https://
the availability of a revised draft www.regulations.gov. Electronic Submissions
guidance entitled ‘‘Drug Interaction Dated: October 19, 2017. Submit electronic comments in the
Studies—Study Design, Data Analysis, Anna K. Abram, following way:
Implications for Dosing, and Labeling
Recommendations.’’ We received
Deputy Commissioner for Policy, Planning, • Federal eRulemaking Portal:
Legislation, and Analysis. https://www.regulations.gov. Follow the
comments on the 2012 draft guidance
[FR Doc. 2017–23102 Filed 10–24–17; 8:45 am] instructions for submitting comments.
and have considered these comments
while updating the information in the BILLING CODE 4164–01–P Comments submitted electronically,
two draft guidances. In addition, new including attachments, to https://
developments in the field have been www.regulations.gov will be posted to
DEPARTMENT OF HEALTH AND the docket unchanged. Because your
incorporated to reflect the Agency’s
HUMAN SERVICES comment will be made public, you are
current thinking.
The Agency decided to divide the solely responsible for ensuring that your
Food and Drug Administration
2012 draft guidance into two guidances comment does not include any
with one focusing on in vitro DDI [Docket No. FDA–2017–D–5966] confidential information that you or a
evaluation and the other focusing on third party may not wish to be posted,
clinical DDI evaluation. We are Breakthrough Devices Program; Draft such as medical information, your or
Guidance for Industry and Food and anyone else’s Social Security number, or
sradovich on DSK3GMQ082PROD with NOTICES
publishing the two draft guidances to
collect additional public comments. Drug Administration Staff; Availability confidential business information, such
These new draft guidances focus on AGENCY: Food and Drug Administration, as a manufacturing process. Please note
metabolism- and transporter-based drug HHS. that if you include your name, contact
interactions. Other types of interactions, ACTION: Notice of availability. information, or other information that
e.g., drug-therapeutic protein identifies you in the body of your
interactions and pH-dependent drug SUMMARY: The Food and Drug comments, that information will be
interactions, are not included. Separate Administration (FDA or Agency) is posted on https://www.regulations.gov.
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![Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49375
and expedite the review of breakthrough collections of information in 21 CFR taken to avoid any potential confusion
technologies. part 812 have been approved under in the docket.
The Breakthrough Devices Program OMB control number 0910–0078; the DATES: The announcement of the
also supersedes the Priority Review collections of information in 21 CFR guidance is published in the Federal
Program, which implemented statutory part 814, subparts A through E, have Register on October 25, 2017.
criteria for granting priority review to been approved under OMB control ADDRESSES: You may submit either
PMA submissions for medical devices, number 0910–0231; the collections of electronic or written comments on
applied those criteria to other types of information in 21 CFR part 814, subpart Agency guidances at any time as
premarket submissions for medical H, have been approved under OMB follows:
devices, and included standard control number 0910–0332; the
procedures to achieve an efficient collections of information in 21 CFR Electronic Submissions
priority review process. part 820 have been approved under Submit electronic comments in the
II. Significance of Guidance OMB control number 0910–0073; the following way:
collections of information in 21 CFR • Federal eRulemaking Portal:
This draft guidance is being issued part 822 have been approved under https://www.regulations.gov. Follow the
consistent with FDA’s good guidance OMB control number 0910–0449; and instructions for submitting comments.
practices regulation (21 CFR 10.115). the collections of information regarding Comments submitted electronically,
The draft guidance, when finalized, will ‘‘Requests for Feedback on Medical including attachments, to https://
represent the current thinking of FDA Device Submissions’’ have been www.regulations.gov will be posted to
on ‘‘Breakthrough Devices Program; approved under OMB control number the docket unchanged. Because your
Draft Guidance for Industry and Food 0910–0756. comment will be made public, you are
and Drug Administration Staff.’’ It does solely responsible for ensuring that your
not establish any rights for any person Dated: October 20, 2017.
comment does not include any
and is not binding on FDA or the public. Leslie Kux, confidential information that you or a
You can use an alternative approach if Associate Commissioner for Policy. third party may not wish to be posted,
it satisfies the requirements of the [FR Doc. 2017–23195 Filed 10–24–17; 8:45 am] such as medical information, your or
applicable statutes and regulations. This BILLING CODE 4164–01–P anyone else’s Social Security number, or
guidance is not subject to Executive confidential business information, such
Order 12866. as a manufacturing process. Please note
DEPARTMENT OF HEALTH AND that if you include your name, contact
III. Electronic Access
HUMAN SERVICES information, or other information that
Persons interested in obtaining a copy identifies you in the body of your
of the draft guidance may do so by Food and Drug Administration comments, that information will be
downloading an electronic copy from posted on https://www.regulations.gov.
[Docket No. FDA–2011–D–0453]
the internet. A search capability for all • If you want to submit a comment
Center for Devices and Radiological Deciding When To Submit a 510(k) for with confidential information that you
Health guidance documents is available a Change to an Existing Device; do not wish to be made available to the
at https://www.fda.gov/MedicalDevices/ Guidance for Industry and Food and public, submit the comment as a
DeviceRegulationandGuidance/ Drug Administration Staff; Availability written/paper submission and in the
GuidanceDocuments/default.htm. manner detailed (see ‘‘Written/Paper
Guidance documents are also available AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’).
at https://www.fda.gov/BiologicsBlood HHS.
Vaccines/GuidanceCompliance ACTION: Notice of availability. Written/Paper Submissions
RegulatoryInformation/default.htm or Submit written/paper submissions as
https://www.regulations.gov. Persons SUMMARY: The Food and Drug follows:
unable to download an electronic copy Administration (FDA or Agency) is • Mail/Hand delivery/Courier (for
of ‘‘Breakthrough Devices Program’’ may announcing the availability of the written/paper submissions): Dockets
send an email request to CDRH- guidance entitled ‘‘Deciding When to Management Staff (HFA–305), Food and
Guidance@fda.hhs.gov to receive an Submit a 510(k) for a Change to an Drug Administration, 5630 Fishers
electronic copy of the document. Please Existing Device.’’ FDA is issuing this Lane, Rm. 1061, Rockville, MD 20852.
use the document number 1833 to final guidance document to clarify when • For written/paper comments
identify the guidance you are a change in a legally marketed medical submitted to the Dockets Management
requesting. device would require that a Staff, FDA will post your comment, as
manufacturer submit a premarket well as any attachments, except for
IV. Paperwork Reduction Act of 1995 notification (510(k)) to FDA. This information submitted, marked and
This guidance refers to previously guidance document supersedes identified, as confidential, if submitted
approved collections of information ‘‘Deciding When to Submit a 510(k) for as detailed in ‘‘Instructions.’’
found in FDA regulations. These a Change to an Existing Device,’’ issued Instructions: All submissions received
collections of information are subject to January 10, 1997. FDA is correcting an must include the Docket No. FDA–
review by the Office of Management and error in the docket number assigned to 2011–D–0453 for ‘‘Deciding When to
Budget (OMB) under the Paperwork the ‘‘Deciding When to Submit a 510(k) Submit a 510(k) for a Change to an
Reduction Act of 1995 (44 U.S.C. 3501– for a Change to an Existing Device’’ Existing Device.’’ Received comments
sradovich on DSK3GMQ082PROD with NOTICES
3520). The collections of information in notice of availability when it published will be placed in the docket and, except
21 CFR part 807, subpart E have been in the Federal Register (81 FR 52443, for those submitted as ‘‘Confidential
approved under OMB control number August 8, 2016). The docket number Submissions,’’ publicly viewable at
0910–0120; the collections of currently is FDA–2016–D–2021. FDA is https://www.regulations.gov or at the
information for De Novo classification changing the docket number to FDA– Dockets Management Staff between 9
requests have been approved under 2011–D–0453. This action is a.m. and 4 p.m., Monday through
OMB control number 0910–0844; the administrative in nature and is being Friday.
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Document Created: 2017-10-25 01:17:49
Document Modified: 2017-10-25 01:17:49
| 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 of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by December 26, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Erin Cutts, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1625, Silver Spring, MD 20993-0002, 301-796-6307; 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, 240-402-7911. | |
| FR Citation | 82 FR 49373 |
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