80 FR 19672 - Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval; 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 | 19672-19673 | |
| FR Document | 2015-08363 |
[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)] [Notices] [Pages 19672-19673] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-08363] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-0090] Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval; 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) is announcing the availability of the guidance entitled ``Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.'' This guidance clarifies FDA's current policy on balancing premarket and postmarket data collection during the Agency's review of premarket approval applications (PMA). Specifically, this guidance outlines how FDA considers the role of postmarket information in determining the appropriate type and amount of data that should be collected in the premarket setting to support premarket approval, while still meeting the statutory standard of safety and effectiveness. FDA believes this guidance will improve patient access to safe and effective medical devices that are important to public health by improving the predictability, consistency, transparency, and efficiency of the premarket process. 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 ``Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval'' 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 has long applied postmarket controls as a way to reduce premarket data collection, where appropriate, while assuring that the statutory standard for approval of reasonable assurance of safety and effectiveness is still met. The right balance of premarket and postmarket data collection facilitates timely patient access to important new technology without undermining patient safety. In this guidance, FDA describes existing statutory requirements under the Federal Food, Drug, and Cosmetic Act, its implementing regulations, and FDA policies that support the policy on balancing premarket and postmarket data collection during review of PMAs. In addition, FDA clarifies how the Agency considers postmarket data as part of the benefit-risk framework described in FDA's guidance ``Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,'' issued on March 28, 2012. This guidance provides a resource for industry and FDA staff on how FDA determines when it is appropriate for a sponsor of a PMA to collect some data (clinical or non-clinical) in the postmarket setting, rather than premarket. 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 an increased focus on patient outcomes and additional examples to help industry better understand when it may be appropriate to shift data collection from the premarket to postmarket setting. The final guidance also recognizes the potential for use of registry data to satisfy post- approval study requirements. 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 balancing premarket and postmarket data collection for devices subject to premarket approval. 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 Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov or from CBER at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to download an electronic copy of ``Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1833 to [[Page 19673]] 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 801 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 803 have been approved under OMB control number 0910-0437; the collections of information in 21 CFR part 812 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; the collection of information in 21 CFR part 860, subpart C have been approved under OMB control number 0910-0138; and the collections of information in the guidance document regarding requests for feedback on medical device submission have been 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. 2015-08363 Filed 4-10-15; 8:45 am] BILLING CODE 4164-01-P
![19672 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices
petitions. It is only necessary to send ADDRESSES: An electronic copy of the Agency considers postmarket data as
one set of comments. Identify comments guidance document is available for part of the benefit-risk framework
with the docket number found in download from the Internet. See the described in FDA’s guidance ‘‘Factors to
brackets in the heading of this SUPPLEMENTARY INFORMATION section for Consider When Making Benefit-Risk
document. If you submit a written information on electronic access to the Determinations in Medical Device
petition, two copies are required. A guidance. Submit written requests for a Premarket Approval and De Novo
petition submitted electronically must single hard copy of the guidance Classifications,’’ issued on March 28,
be submitted to http:// document entitled ‘‘Balancing 2012. This guidance provides a resource
www.regulations.gov, Docket No. FDA– Premarket and Postmarket Data for industry and FDA staff on how FDA
2013–S–0610. Comments and petitions Collection for Devices Subject to determines when it is appropriate for a
that have not been made publicly Premarket Approval’’ to the Office of the sponsor of a PMA to collect some data
available on http://www.regulations.gov Center Director, Guidance and Policy (clinical or non-clinical) in the
may be viewed in the Division of Development, Center for Devices and postmarket setting, rather than
Dockets Management between 9 a.m. Radiological Health, Food and Drug premarket.
and 4 p.m., Monday through Friday. Administration, 10903 New Hampshire A draft of this guidance was made
Ave., Bldg. 66, Rm. 5431, Silver Spring, available in the Federal Register on
Dated: April 7, 2015.
MD 20993–0002 or to the Office of April 23, 2014, and the comment period
Leslie Kux, closed July 22, 2014. Changes between
Communication, Outreach and
Associate Commissioner for Policy. the draft and final versions of this
Development, Center for Biologics
[FR Doc. 2015–08362 Filed 4–10–15; 8:45 am]
Evaluation and Research, Food and guidance include an increased focus on
BILLING CODE 4164–01–P Drug Administration, 10903 New patient outcomes and additional
Hampshire Ave., Bldg. 71, Rm. 3128, examples to help industry better
Silver Spring, MD 20993–0002. Send understand when it may be appropriate
DEPARTMENT OF HEALTH AND to shift data collection from the
one self-addressed adhesive label to
HUMAN SERVICES premarket to postmarket setting. The
assist that office in processing your
request. final guidance also recognizes the
Food and Drug Administration potential for use of registry data to
Submit electronic comments on the
[Docket No. FDA–2014–D–0090] guidance to http://www.regulations.gov. satisfy post-approval study
Submit written comments to the requirements.
Balancing Premarket and Postmarket Division of Dockets Management (HFA–
Data Collection for Devices Subject to II. Significance of Guidance
305), Food and Drug Administration,
Premarket Approval; Guidance for This guidance is being issued
5630 Fishers Lane, Rm. 1061, Rockville,
Industry and Food and Drug consistent with FDA’s good guidance
MD 20852. Identify comments with the
Administration Staff; Availability practices regulation (21 CFR 10.115).
docket number found in brackets in the The guidance represents the Agency’s
AGENCY: Food and Drug Administration, heading of this document. current thinking on balancing premarket
HHS. FOR FURTHER INFORMATION CONTACT: and postmarket data collection for
ACTION: Notice. Aaron Josephson, Center for Devices devices subject to premarket approval. It
and Radiological Health, Food and Drug does not create or confer any rights for
SUMMARY: The Food and Drug Administration, 10903 New Hampshire or on any person and does not operate
Administration (FDA) is announcing the Ave., Bldg. 66, Rm. 5449, Silver Spring, to bind FDA or the public. An
availability of the guidance entitled MD 20993–0002, 301–796–5178; or alternative approach may be used if
‘‘Balancing Premarket and Postmarket Stephen Ripley, Center for Biologics such approach satisfies the
Data Collection for Devices Subject to Evaluation and Research, Food and requirements of the applicable statute
Premarket Approval.’’ This guidance Drug Administration, 10903 New and regulations.
clarifies FDA’s current policy on Hampshire Ave., Bldg. 71, Rm. 7301,
balancing premarket and postmarket Silver Spring, MD 20993–0002. III. Electronic Access
data collection during the Agency’s SUPPLEMENTARY INFORMATION: Persons interested in obtaining a copy
review of premarket approval of the guidance may do so by
applications (PMA). Specifically, this I. Background downloading an electronic copy from
guidance outlines how FDA considers FDA has long applied postmarket the Internet. A search capability for all
the role of postmarket information in controls as a way to reduce premarket Center for Devices and Radiological
determining the appropriate type and data collection, where appropriate, Health guidance documents is available
amount of data that should be collected while assuring that the statutory at http://www.fda.gov/MedicalDevices/
in the premarket setting to support standard for approval of reasonable DeviceRegulationandGuidance/
premarket approval, while still meeting assurance of safety and effectiveness is GuidanceDocuments/default.htm.
the statutory standard of safety and still met. The right balance of premarket Guidance documents are also available
effectiveness. FDA believes this and postmarket data collection at http://www.regulations.gov or from
guidance will improve patient access to facilitates timely patient access to CBER at http://www.fda.gov/Biologics
safe and effective medical devices that important new technology without BloodVaccines/GuidanceCompliance
are important to public health by undermining patient safety. RegulatoryInformation/default.htm.
improving the predictability,
mstockstill on DSK4VPTVN1PROD with NOTICES
In this guidance, FDA describes Persons unable to download an
consistency, transparency, and existing statutory requirements under electronic copy of ‘‘Balancing Premarket
efficiency of the premarket process. the Federal Food, Drug, and Cosmetic and Postmarket Data Collection for
DATES: Submit either electronic or Act, its implementing regulations, and Devices Subject to Premarket Approval’’
written comments on this guidance at FDA policies that support the policy on may send an email request to CDRH-
any time. General comments on Agency balancing premarket and postmarket Guidance@fda.hhs.gov to receive an
guidance documents are welcome at any data collection during review of PMAs. electronic copy of the document. Please
time. In addition, FDA clarifies how the use the document number 1833 to
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![Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices 19673
identify the guidance you are DEPARTMENT OF HEALTH AND products to protect public health and to
requesting. HUMAN SERVICES reduce tobacco use by minors. Section
1003(d)(2)(D) of the FD&C Act (21
IV. Paperwork Reduction Act of 1995 Food and Drug Administration U.S.C. 393(d)(2)(D)) supports the
This guidance refers to previously [Docket No. FDA–2014–N–2294] development and implementation of
approved collections of information FDA public education campaigns
found in FDA regulations. These Agency Information Collection related to tobacco use. Accordingly,
Activities; Submission for Office of FDA is currently developing and
collections of information are subject to
Management and Budget Review; implementing a youth-targeted public
review by the Office of Management and
Comment Request; Evaluation of the education campaign (‘Fresh Empire’) to
Budget (OMB) under the Paperwork
Food and Drug Administration’s ‘Fresh help prevent tobacco use among
Reduction Act of 1995 (44 U.S.C. 3501– multicultural youth and thereby reduce
Empire’ Multicultural Youth Tobacco
3520). The collections of information in Prevention Campaign the public health burden of tobacco. The
21 CFR part 801 have been approved campaign will feature events,
under OMB control number 0910–0485; AGENCY: Food and Drug Administration, advertisements on television and radio
the collections of information in 21 CFR HHS. and in print, digital communications
part 803 have been approved under ACTION: Notice. including social media, and other forms
OMB control number 0910–0437; the of media.
SUMMARY: The Food and Drug
collections of information in 21 CFR In support of the provisions of the
Administration (FDA) is announcing
part 812 have been approved under that a proposed collection of Tobacco Control Act that require FDA to
OMB control number 0910–0073; the information has been submitted to the protect the public health and to reduce
collections of information in 21 CFR Office of Management and Budget tobacco use by minors, FDA requests
part 822 have been approved under (OMB) for review and clearance under OMB approval to collect information
OMB control number 0910–0449; the the Paperwork Reduction Act of 1995. needed to evaluate FDA’s ‘Fresh
collection of information in 21 CFR part DATES: Fax written comments on the
Empire’ multicultural youth tobacco
860, subpart C have been approved collection of information by May 13, prevention campaign. Comprehensive
under OMB control number 0910–0138; 2015. evaluation of FDA’s public education
and the collections of information in the campaigns is needed to ensure
ADDRESSES: To ensure that comments on campaign messages are effectively
guidance document regarding requests
the information collection are received, received, understood, and accepted by
for feedback on medical device OMB recommends that written
submission have been approved under those for whom they are intended.
comments be faxed to the Office of Evaluation is an essential organizational
OMB control number 0910–0756. Information and Regulatory Affairs, practice in public health and a
V. Comments OMB, Attn: FDA Desk Officer, FAX: systematic way to account for and
202–395–7285, or emailed to improve public health actions.
Interested persons may submit either oira_submission@omb.eop.gov. All FDA plans to evaluate the
electronic comments regarding this comments should be identified with the effectiveness of its multicultural youth
document to http://www.regulations.gov OMB control number 0910–NEW and tobacco prevention campaign through
or written comments to the Division of title ‘‘Evaluation of the Food and Drug an outcome evaluation study that will
Dockets Management (see ADDRESSES). It Administration’s ‘Fresh Empire’ be designed to follow the multiple,
is only necessary to send one set of Multicultural Youth Tobacco Prevention discrete waves of media advertising
comments. Identify comments with the Campaign.’’ Also include the FDA planned for the campaign.
docket number found in brackets in the docket number found in brackets in the The outcome evaluation study
heading of this document. Received heading of this document. consists of a pre-test survey of
comments may be seen in the Division FOR FURTHER INFORMATION CONTACT: FDA multicultural youth aged 12 to 17 before
of Dockets Management between 9 a.m. PRA Staff, Office of Operations, Food campaign launch. The pre-test survey
and 4 p.m., Monday through Friday, and and Drug Administration, 8455 will be followed by ongoing cross-
will be posted to the docket at http:// Colesville Rd., COLE–14526, Silver sectional surveys of the target audience
www.regulations.gov. Spring, MD 20993–0002, PRAStaff@ of youth beginning approximately 3
fda.hhs.gov. months following campaign launch.
Dated: April 7, 2015.
SUPPLEMENTARY INFORMATION: In Information will be collected about
Leslie Kux, youth awareness of and exposure to
compliance with 44 U.S.C. 3507, FDA
Associate Commissioner for Policy. campaign events and advertisements
has submitted the following proposed
[FR Doc. 2015–08363 Filed 4–10–15; 8:45 am]
collection of information to OMB for and about tobacco-related knowledge,
BILLING CODE 4164–01–P review and clearance. attitudes, beliefs, intentions, and use.
Information will also be collected on
Evaluation of the Food and Drug demographic variables including age,
Administration’s ‘Fresh Empire’ sex, race/ethnicity, grade level, and
Multicultural Youth Tobacco primary language.
Prevention Campaign (OMB Control All information will be collected
Number 0910–NEW)
mstockstill on DSK4VPTVN1PROD with NOTICES
through in-person and Web-based
The 2009 Family Smoking Prevention questionnaires. Youth respondents will
and Tobacco Control Act (Tobacco be recruited from two sources: (1) A
Control Act) (Pub. L. 111–31) amended sample drawn from 30 U.S. media
the Federal Food, Drug, and Cosmetic markets gathered using an address-
Act (the FD&C Act) to grant FDA based postal mail sampling of U.S.
authority to regulate the manufacture, households for the outcome evaluation
marketing, and distribution of tobacco studies and (2) targeted social media
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Document Created: 2015-12-18 11:21:45
Document Modified: 2015-12-18 11:21:45
| 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 19672 |
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