Providing Information About Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability, 24731-24732 [2014-09897]

Download as PDF Federal Register / Vol. 79, No. 84 / Thursday, May 1, 2014 / Notices 24731 TABLE 2—AREAS OF INTEREST—IN VITRO DIAGNOSTIC AND RADIOLOGICAL DEVICES/TECHNOLOGY Focus area Specific areas of interest Artificial pancreas related devices ............................................................ Manufacturing of continuous glucose monitoring devices and insulin pumps. Manufacturing of antibodies (monoclonal and polyclonal) for immunoassay tests. Coagulation devices for point of care and home use (COUMADIN selfmonitoring) utilizing whole blood and/or citrated plasma. Immunohistochemistry as an important tool in biomarkers detection and clinical practice. Systems maintaining quality oversight of data generated at a distant location and transmitted digitally to another location for analysis. Manufacturing of different types of human antibodies for the use of immunoassays. Coagulation point of care and home use devices ................................... Immunohistochemistry for the diagnostic evaluation for cancer .............. Systems capable of running multiple analytes composed of a specimen collection and processing unit at satellite locations and data transmittal to a central location for analysis and quality control oversight. Antimicrobial resistance detection and characterization .......................... Diagnostic x-ray imaging devices ............................................................. Next generation sequencing/single-nucleotide polymorphism (SNP) arrays and clinical genomics. B. Site Selection CDRH will be responsible for all CDRH staff travel expenses associated with the site visits. CDRH cannot provide funds to support the proposed training provided by the applicants to this program. Selection of potential facilities will be based on CDRH’s priorities for staff training and resources available to fund this program. In addition to logistical and other resource factors, all sites must have a successful compliance record with FDA or another Agency with which FDA has a memorandum of understanding. If a site visit involves a visit to a separate physical location of another firm under contract to the applicant, that firm must agree to participate in the program and must also have a satisfactory compliance history. III. Request for Participation Identify requests for participation with the docket number found in the brackets in the heading of this document. Received requests may be seen in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 25, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–09916 Filed 4–30–14; 8:45 am] tkelley on DSK3SPTVN1PROD with NOTICES BILLING CODE 4160–01–P VerDate Mar<15>2010 17:30 Apr 30, 2014 Jkt 232001 Observation and hands-on experience with reference methods and assays for phenotypic and non-phenotypic-based methods for determining antimicrobial resistance. Site visits to user facilities. Next generation sequencing and/or SNP array devices in the clinical laboratory setting for molecular diagnostics used. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0458] Providing Information About Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Providing Information about Pediatric Uses of Medical Devices.’’ FDA is issuing this guidance document to describe how to compile and submit the readily available pediatric use information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). 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 ‘‘Providing Information About Pediatric Uses of Medical Devices’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002 or Office SUMMARY: PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your request. Submit electronic comments on the guidance to https://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: Sheila Brown, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1651, Silver Spring, MD 20993–0002, 301–796–6563; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852, 301–827–6210. I. Background On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) 1 (Pub. L. 110–85) amended the FD&C Act by adding, among other things, a new section 515A (21 U.S.C. 360e–1) of the FD&C Act. Section 515A(a) of the FD&C Act requires persons who submit certain medical device applications to include, if readily available: (1) A description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or 1 Title III of FDAAA, which includes new section 515A, is also known as the Pediatric Medical Device Safety and Improvement Act of 2007. E:\FR\FM\01MYN1.SGM 01MYN1 24732 Federal Register / Vol. 79, No. 84 / Thursday, May 1, 2014 / Notices cure and (2) the number of affected pediatric patients. The purpose of this guidance document is to describe the type of information that FDA believes is readily-available to the applicant, and the information FDA believes should be included in a submission to meet the requirements of section 515A(a) of the FD&C Act. The draft version of this guidance was issued on February 19, 2013 (78 FR 11654). 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 requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure. 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. tkelley on DSK3SPTVN1PROD with NOTICES 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. Guidance documents are also available at https://www.regulations.gov or from CBER at https://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/default.htm. Persons unable to download an electronic copy of ‘‘Providing Information about Pediatric Uses of Medical Devices,’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1801 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 On January 9, 2014, the Agency submitted a proposed collection of information entitled ‘‘Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug and Cosmetic Act’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. VerDate Mar<15>2010 17:30 Apr 30, 2014 Jkt 232001 OMB has now approved the information collection and has assigned OMB control number 0910–0762. The approval expires on March 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. This guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR part 814, subpart B have been approved under OMB control number 0910–0231 and the collections of information in 21 CFR part 814, subpart H have been approved under OMB control number 0910–0332. V. Comments Interested persons may submit either written comments regarding this document to https://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 https:// www.regulations.gov. Dated: April 25, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–09897 Filed 4–30–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0366] Pilot Program for Center for Devices and Radiological Health Electronic Submission of Premarket Notification Submissions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is announcing the availability of a CDRH eSubmissions Pilot Program (eSubmissions Pilot), which will be a new pathway that will guide the user through constructing and submitting their 510(k) submissions electronically without the requirement for submitting a hard copy or a compact disc. Participation in the eSubmissions Pilot is open to applicants whose device SUMMARY: PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 submissions would be reviewed in either of two branches in CDRH’s Office of Device Evaluation (ODE), the Cardiac Diagnostic Devices Branch and the Peripheral Interventional Devices Branch, and is limited to unbundled, traditional 510(k) submissions for classified devices only. The eSubmissions Pilot will use the existing eSubmitter software for data acquisition and the existing Electronic Submission Gateway (ESG) for submitting (the eSubmissions Pilot is not intended to evaluate the existing eSubmitter software or the existing ESG). The eSubmissions Pilot is intended to provide industry and CDRH staff the opportunity to evaluate the 510(k) eSubmission with regards to the content (wording of questions, help text and guides), layout, and flow of the questions. DATES: FDA will begin accepting requests to participate in the eSubmissions Pilot immediately. See the ‘‘Procedures’’ section for instructions on how to submit a request. FOR FURTHER INFORMATION CONTACT: Patrick Axtell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1566, Silver Spring, MD 20993–0002, eSubpilot@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA has been moving toward transforming all regulatory submissions from paper to electronic methods. Since January 1999, FDA has accepted voluntary electronic submissions for certain types of regulatory submissions. FDA presently utilizes eSubmitter as a platform for submitting many types of submissions across several Centers. The eSubmitter platform contains templates for many types of submissions specific to those Centers and any template can be chosen by the user for constructing and submitting the appropriate type of submission. The 510(k) eSubmission program introduces a new template in eSubmitter for use in submitting 510(k)s to ODE. FDA presently utilizes the ESG for the receipt and processing of many types of electronic regulatory submissions (https://www.fda.gov/ForIndustry/ ElectronicSubmissionsGateway/ default.htm). The ESG automates the receipt, acknowledgment, routing and notification of electronic submissions via the Internet and meets FDAs standards of electronic information exchange. The benefits to industry of this pilot program include, but are not limited to: E:\FR\FM\01MYN1.SGM 01MYN1

Agencies

[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Pages 24731-24732]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09897]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0458]


Providing Information About Pediatric Uses of Medical Devices; 
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 ``Providing Information about 
Pediatric Uses of Medical Devices.'' FDA is issuing this guidance 
document to describe how to compile and submit the readily available 
pediatric use information required under the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act).

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 
``Providing Information About Pediatric Uses of Medical Devices'' to 
the Office of the Center Director, Guidance and Policy Development, 
Center for Devices and Radiological Health (CDRH), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002 or Office of Communication, Outreach and 
Development (HFM-40), Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist that office in processing your request.
    Submit electronic comments on the guidance to https://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: Sheila Brown, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1651, Silver Spring, MD 20993-0002, 301-796-6563; 
or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852, 301-827-6210.

I. Background

    On September 27, 2007, the Food and Drug Administration Amendments 
Act of 2007 (FDAAA) \1\ (Pub. L. 110-85) amended the FD&C Act by 
adding, among other things, a new section 515A (21 U.S.C. 360e-1) of 
the FD&C Act. Section 515A(a) of the FD&C Act requires persons who 
submit certain medical device applications to include, if readily 
available: (1) A description of any pediatric subpopulations that 
suffer from the disease or condition that the device is intended to 
treat, diagnose, or

[[Page 24732]]

cure and (2) the number of affected pediatric patients.
---------------------------------------------------------------------------

    \1\ Title III of FDAAA, which includes new section 515A, is also 
known as the Pediatric Medical Device Safety and Improvement Act of 
2007.
---------------------------------------------------------------------------

    The purpose of this guidance document is to describe the type of 
information that FDA believes is readily-available to the applicant, 
and the information FDA believes should be included in a submission to 
meet the requirements of section 515A(a) of the FD&C Act. The draft 
version of this guidance was issued on February 19, 2013 (78 FR 11654).

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 requirements relating to the 
submission of information on pediatric subpopulations that suffer from 
the disease or condition that a device is intended to treat, diagnose, 
or cure. 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.regulations.gov or from CBER 
at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``Providing Information about Pediatric 
Uses of Medical Devices,'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 1801 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    On January 9, 2014, the Agency submitted a proposed collection of 
information entitled ``Providing Information About Pediatric Uses of 
Medical Devices Under Section 515A of the Federal Food, Drug and 
Cosmetic Act'' to OMB for review and clearance under 44 U.S.C. 3507. An 
Agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number. OMB has now approved the information 
collection and has assigned OMB control number 0910-0762. The approval 
expires on March 31, 2017. A copy of the supporting statement for this 
information collection is available on the Internet at https://www.reginfo.gov/public/do/PRAMain.
    This guidance also refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
21 CFR part 814, subpart B have been approved under OMB control number 
0910-0231 and the collections of information in 21 CFR part 814, 
subpart H have been approved under OMB control number 0910-0332.

V. Comments

    Interested persons may submit either written comments regarding 
this document to https://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 https://www.regulations.gov.

    Dated: April 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09897 Filed 4-30-14; 8:45 am]
BILLING CODE 4160-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.