Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Guidance for Industry and Food and Drug Administration Staff; Availability, 45771-45773 [2019-18802]

Download as PDF Federal Register / Vol. 84, No. 169 / Friday, August 30, 2019 / Notices USPTO requested that FDA determine the product’s regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for NERLYNX is 5,102 days. Of this time, 4,738 days occurred during the testing phase of the regulatory review period, while 364 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: July 31, 2003. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was July 31, 2003. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: July 19, 2016. FDA has verified the applicant’s claim that the new drug application (NDA) for NERLYNX (NDA 208051) was initially submitted on July 19, 2016. 3. The date the application was approved: July 17, 2017. FDA has verified the applicant’s claim that NDA 208051 was approved on July 17, 2017. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 472 days or 1,826 days of patent term extension. jspears on DSK3GMQ082PROD with NOTICES III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. VerDate Sep<11>2014 16:43 Aug 29, 2019 Jkt 247001 Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: August 26, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–18816 Filed 8–29–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–3130] Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.’’ This guidance document describes FDA’s current approach to considering uncertainty in making benefit-risk determinations to support certain FDA premarket decisions for medical devices— premarket approval applications (PMAs), De Novo requests, and humanitarian device exemption applications. This guidance document elaborates on the consideration of uncertainty as part of our overarching approach to a benefit-risk based framework that is intended to assure greater predictability, consistency, and efficiency through the application of least burdensome principles. This guidance also provides examples of how the principles for considering uncertainty could be applied in the context of clinical evidence and circumstances where greater uncertainty could be appropriate in premarket decisions, balanced by postmarket controls—PMAs for Breakthrough Devices and PMAs for devices for small patient populations. SUMMARY: PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 45771 The announcement of the guidance is published in the Federal Register on August 30, 2019. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: DATES: 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. • 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– 2018–D–3130 for ‘‘Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Guidance for Industry and Food and Drug Administration Staff; Availability.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at E:\FR\FM\30AUN1.SGM 30AUN1 jspears on DSK3GMQ082PROD with NOTICES 45772 Federal Register / Vol. 84, No. 169 / Friday, August 30, 2019 / Notices 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 guidance document entitled ‘‘Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions’’ to the Office of Policy, Guidance and Policy Development, Center for Devices and VerDate Sep<11>2014 16:43 Aug 29, 2019 Jkt 247001 Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Sonja Fulmer, Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5451, Silver Spring, MD 20993–0002, 240–402–5979. SUPPLEMENTARY INFORMATION: I. Background The 1976 Medical Device Amendments (Pub. L. 94–295) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) established a risk-based framework for the regulation of medical devices. The law established a threetiered risk classification system based on the risk posed to patients should the device fail to perform as intended. Under this system, devices that pose greater risks to patients are subject to more regulatory controls and requirements. Generally, for any regulatory decision, there exists some uncertainty around benefits and risks. The Agency generally provides marketing authorization for a device when it meets the applicable standards, including that its benefits outweigh its risks. In 2015, following pilots conducted over 4 years, FDA established the Expedited Access Pathway (EAP) Program as a voluntary program for certain medical devices that address an unmet need in the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Under this program, an eligible device subject to a PMA could be approved with greater uncertainty about the product’s benefits and risks, provided that, among other requirements, the data still support a reasonable assurance of safety and effectiveness, including that the probable benefits of the device outweigh its risks for a patient population with unmet medical needs. For devices subject to PMA, the Agency has the authority to impose, when warranted, postmarket requirements, including post-approval studies and postmarket surveillance, as a condition of approval, which could be used to address this greater uncertainty.1 In the Breakthrough Device provisions of the 1 See sections 513(a)(3)(C), 515(c)(5)(C), 515(d)(1)(B)(ii), and 515B(e)(2)(C) of the FD&C Act (21 U.S.C. 360c(a)(3)(C), 360e(c)(5)(C), 360e(d)(1)(B)(ii), and 360e–3(e)(2)(C)); 21 CFR 814.82. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 FD&C Act, as added by the 21st Century Cures Act (Cures Act) and amended by the FDA Reauthorization Act of 2017 (FDARA), Congress codified and expanded this program to include devices reviewed through a 510(k) notification.2 This guidance provides further information on how FDA considers uncertainty in benefit-risk determinations for PMAs, De Novo requests, and Humanitarian Device Exemption applications. FDA considered comments received on the draft guidance that appeared in the Federal Register of September 6, 2018 (83 FR 45247). FDA revised the guidance as appropriate in response to the comments. 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 current thinking of FDA on Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions. 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 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. This guidance document is also available at https://www.regulations.gov or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/default.htm. Persons unable to download an electronic copy of ‘‘Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 17039 to identify the guidance you are requesting. 2 See section 515B of the FD&C Act, as created by section 3051 of the Cures Act (Pub. L. 114–255) and amended by section 901 of FDARA (Pub. L. 115– 52). E:\FR\FM\30AUN1.SGM 30AUN1 Federal Register / Vol. 84, No. 169 / Friday, August 30, 2019 / Notices IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information. 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 45773 of information in the following FDA regulations and guidance have been approved by OMB as listed in the following table: OMB control No. 21 CFR part; guidance; or FDA form Topic 814, subparts A through E ......................................................... 814, subpart H ............................................................................ ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’. ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff‘‘. 801 and 809 ............................................................................... 822 .............................................................................................. Premarket approval .................................................................... Humanitarian Device Exemption ................................................ De Novo classification process .................................................. 0910–0231 0910–0332 0910–0844 Q-submissions ............................................................................ 0910–0756 Medical Device Labeling Regulations ........................................ Postmarket Surveillance of Medical Devices ............................. 0910–0485 0910–0449 Dated: August 27, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–18802 Filed 8–29–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–3926] Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good SUMMARY: Manufacturing Practice Advisory Committee (DGMPAC) and the Medical Devices Advisory Committee (MDAC) device panels in the Center for Devices and Radiological Health. This annual notice is also in accordance with the 21st Century Cures Act, which requires the Secretary of Health and Human Services (the Secretary) to provide an annual opportunity for patients, representatives of patients, and sponsors of medical devices that may be specifically the subject of a review by a classification panel to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore, encourages nominations of appropriately qualified candidates from these groups. DATES: Nominations received on or before October 29, 2019 will be given first consideration for membership on the DGMPAC and Panels of the MDAC. Nominations received after October 29, 2019 will be considered for nomination to the committee as later vacancies occur. All nominations for membership should be submitted electronically by logging into the FDA Advisory Nomination Portal: https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for membership, contact the following persons listed in table 1: TABLE 1—PRIMARY CONTACT AND COMMITTEE OR PANEL jspears on DSK3GMQ082PROD with NOTICES Primary contact person Committee or panel Joannie Adams-White, Office of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5519, Silver Spring, MD 20993, 301– 796–5421, email: Joannie.Adams-White@fda.hhs.gov. LCDR Sara Anderson, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G616, Silver Spring, MD 20993, 301–796–7047, email: Sara.Anderson@fda.hhs.gov. Aden S. Asefa, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993, 301–796–0400, email: Aden.Asefa@fda.hhs.gov. LCDR Patricio G. Garcia, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993, 301–796–6875, email: Patricio.Garcia@fda.hhs.gov. VerDate Sep<11>2014 16:43 Aug 29, 2019 Jkt 247001 PO 00000 Frm 00065 Fmt 4703 Medical Devices Dispute Resolution Panel. Dental Products Panel, Hematology and Pathology Devices Panel, Orthopaedic and Rehabilitation Devices Panel, Radiological Devices Panel. Immunology Devices Panel, Microbiology Devices Panel, Neurological Devices Panel, Ophthalmic Devices Panel, DGMPAC. Clinical Chemistry and Clinical Toxicology Devices Panel, Gastroenterology and Urology Devices Panel, General and Plastic Surgery Devices Panel, Obstetrics and Gynecology Devices Panel. Sfmt 4703 E:\FR\FM\30AUN1.SGM 30AUN1

Agencies

[Federal Register Volume 84, Number 169 (Friday, August 30, 2019)]
[Notices]
[Pages 45771-45773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18802]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3130]


Consideration of Uncertainty in Making Benefit-Risk 
Determinations in Medical Device Premarket Approvals, De Novo 
Classifications, and Humanitarian Device Exemptions; 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 a final guidance entitled ``Consideration of 
Uncertainty in Making Benefit-Risk Determinations in Medical Device 
Premarket Approvals, De Novo Classifications, and Humanitarian Device 
Exemptions.'' This guidance document describes FDA's current approach 
to considering uncertainty in making benefit-risk determinations to 
support certain FDA premarket decisions for medical devices--premarket 
approval applications (PMAs), De Novo requests, and humanitarian device 
exemption applications. This guidance document elaborates on the 
consideration of uncertainty as part of our overarching approach to a 
benefit-risk based framework that is intended to assure greater 
predictability, consistency, and efficiency through the application of 
least burdensome principles. This guidance also provides examples of 
how the principles for considering uncertainty could be applied in the 
context of clinical evidence and circumstances where greater 
uncertainty could be appropriate in premarket decisions, balanced by 
postmarket controls--PMAs for Breakthrough Devices and PMAs for devices 
for small patient populations.

DATES: The announcement of the guidance is published in the Federal 
Register on August 30, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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.
     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-2018-D-3130 for ``Consideration of Uncertainty in Making Benefit-
Risk Determinations in Medical Device Premarket Approvals, De Novo 
Classifications, and Humanitarian Device Exemptions; Guidance for 
Industry and Food and Drug Administration Staff; Availability.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at

[[Page 45772]]

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.gpo.gov/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 guidance document entitled 
``Consideration of Uncertainty in Making Benefit-Risk Determinations in 
Medical Device Premarket Approvals, De Novo Classifications, and 
Humanitarian Device Exemptions'' to the Office of Policy, 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. Send one self-addressed adhesive label to 
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Sonja Fulmer, Office of Policy, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 5451, Silver Spring, MD 20993-
0002, 240-402-5979.

SUPPLEMENTARY INFORMATION:

I. Background

    The 1976 Medical Device Amendments (Pub. L. 94-295) to the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) established a risk-based 
framework for the regulation of medical devices. The law established a 
three-tiered risk classification system based on the risk posed to 
patients should the device fail to perform as intended. Under this 
system, devices that pose greater risks to patients are subject to more 
regulatory controls and requirements. Generally, for any regulatory 
decision, there exists some uncertainty around benefits and risks. The 
Agency generally provides marketing authorization for a device when it 
meets the applicable standards, including that its benefits outweigh 
its risks.
    In 2015, following pilots conducted over 4 years, FDA established 
the Expedited Access Pathway (EAP) Program as a voluntary program for 
certain medical devices that address an unmet need in the treatment or 
diagnosis of life-threatening or irreversibly debilitating diseases or 
conditions. Under this program, an eligible device subject to a PMA 
could be approved with greater uncertainty about the product's benefits 
and risks, provided that, among other requirements, the data still 
support a reasonable assurance of safety and effectiveness, including 
that the probable benefits of the device outweigh its risks for a 
patient population with unmet medical needs. For devices subject to 
PMA, the Agency has the authority to impose, when warranted, postmarket 
requirements, including post-approval studies and postmarket 
surveillance, as a condition of approval, which could be used to 
address this greater uncertainty.\1\ In the Breakthrough Device 
provisions of the FD&C Act, as added by the 21st Century Cures Act 
(Cures Act) and amended by the FDA Reauthorization Act of 2017 (FDARA), 
Congress codified and expanded this program to include devices reviewed 
through a 510(k) notification.\2\
---------------------------------------------------------------------------

    \1\ See sections 513(a)(3)(C), 515(c)(5)(C), 515(d)(1)(B)(ii), 
and 515B(e)(2)(C) of the FD&C Act (21 U.S.C. 360c(a)(3)(C), 
360e(c)(5)(C), 360e(d)(1)(B)(ii), and 360e-3(e)(2)(C)); 21 CFR 
814.82.
    \2\ See section 515B of the FD&C Act, as created by section 3051 
of the Cures Act (Pub. L. 114-255) and amended by section 901 of 
FDARA (Pub. L. 115-52).
---------------------------------------------------------------------------

    This guidance provides further information on how FDA considers 
uncertainty in benefit-risk determinations for PMAs, De Novo requests, 
and Humanitarian Device Exemption applications. FDA considered comments 
received on the draft guidance that appeared in the Federal Register of 
September 6, 2018 (83 FR 45247). FDA revised the guidance as 
appropriate in response to the comments.

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 
current thinking of FDA on Consideration of Uncertainty in Making 
Benefit-Risk Determinations in Medical Device Premarket Approvals, De 
Novo Classifications, and Humanitarian Device Exemptions. 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 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. This 
guidance document is also available at https://www.regulations.gov or 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``Consideration of Uncertainty in Making 
Benefit-Risk Determinations in Medical Device Premarket Approvals, De 
Novo Classifications, and Humanitarian Device Exemptions'' may send an 
email request to [email protected] to receive an electronic 
copy of the document. Please use the document number 17039 to identify 
the guidance you are requesting.

[[Page 45773]]

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. 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 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
21 CFR part; guidance; or FDA form          Topic               No.
------------------------------------------------------------------------
814, subparts A through E.........  Premarket approval..       0910-0231
814, subpart H....................  Humanitarian Device        0910-0332
                                     Exemption.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)''.                 process.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff``.
801 and 809.......................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
822...............................  Postmarket                 0910-0449
                                     Surveillance of
                                     Medical Devices.
------------------------------------------------------------------------


    Dated: August 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18802 Filed 8-29-19; 8:45 am]
BILLING CODE 4164-01-P

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