Policy Clarification for Certain Fluoroscopic Equipment Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability, 20146-20148 [2019-09406]

Download as PDF 20146 Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices I. Background This guidance describes FDA’s policy regarding the regulation of medical xray imaging equipment that is subject to the FD&C Act and FDA’s regulations that apply to medical devices and electronic products. In this guidance, FDA is seeking to harmonize performance standards prescribed pursuant to section 534 of Subchapter C (Electronic Product Radiation Control (EPRC)) of the FD&C Act (21 U.S.C. 360(kk)) with International Electrotechnical Commission (IEC) standards, where appropriate, to help to ensure streamlined regulatory review of submissions for these products. The guidance also provides recommendations to industry on how to comply with the applicable requirements. FDA has determined that industry conformance to certain IEC standards would provide, at a minimum, the same level of protection of the public health and safety from electronic radiation as certain EPRC regulatory standards. In addition, due to the recent publication of a proposed rule (84 FR 12147) on April 1, 2019, that would, if finalized, eliminate the reporting requirements for x-ray imaging devices, FDA determined that the proposed policy outlined in section 4 of the draft guidance, which stated that xray imaging devices that conform to IEC standards would be considered to have met the EPRC reporting requirements, should be removed from the guidance. This decision was made to avoid the confusion inherent in establishing an 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 ‘‘Medical X-Ray Imaging Devices Conformance with IEC Standards.’’ 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. Persons unable to download an electronic copy of ‘‘Medical X-Ray Imaging Devices Conformance with IEC Standards’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1400014 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 In the Federal Register of August 3, 2016 (81 FR 51201), we requested comments on the revision of OMB control number 0910–0025, ‘‘Reporting and Recordkeeping for Electronic Products—General Requirements,’’ to adjust the annual reporting burden consistent with the policy in the draft guidance pertaining to reports. However, because this final guidance does not include this policy pertaining to reports (see the Background section), we have determined that the guidance no longer necessitates revisions to OMB control number 0910–0025. 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 have been approved by OMB as listed in the following table: OMB control No. 21 CFR part Topic 807, subpart E .......................................... 800, 801, and 809 .................................... 820 ............................................................ 1002 through 1050 ................................... Premarket Notification .................................................................................................. Medical Device Labeling Regulations .......................................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ..... Reporting and Recordkeeping for Electronic Products—General Requirements ....... Dated: May 2, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–09405 Filed 5–7–19; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1344] BILLING CODE 4164–01–P khammond on DSKBBV9HB2PROD with NOTICES interim procedure that would shortly be superseded by the final rule. However, as stated in section V. of the guidance, FDA believes that submission of a declaration of conformity to the appropriate standards, and model identification as required by 21 CFR 1002.10(a) and (b), in a product report, would be sufficient to meet the requirements of a product report under 21 CFR 1002.10, thus reducing duplication. FDA considered comments received on the draft guidance that appeared in the Federal Register of August 3, 2016 (81 FR 51201). FDA revised the guidance as appropriate in response to the comments. Policy Clarification for Certain Fluoroscopic Equipment Requirements; 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 SUMMARY: VerDate Sep<11>2014 16:57 May 07, 2019 Jkt 247001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 0910–0120 0910–0485 0910–0073 0910–0025 guidance entitled ‘‘Policy Clarification for Certain Fluoroscopic Equipment Requirements.’’ This guidance document intends to clarify FDA’s interpretation of certain aspects of the performance standard requirements in FDA’s regulations for fluoroscopic equipment. The announcement of the guidance is published in the Federal Register on May 8, 2019. DATES: You may submit either electronic or written comments on Agency guidances at any time as follows: ADDRESSES: E:\FR\FM\08MYN1.SGM 08MYN1 Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices 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’’). khammond on DSKBBV9HB2PROD with NOTICES 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– 2014–D–1344 for ‘‘Policy Clarification for Certain Fluoroscopic Equipment Requirements.’’ 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 VerDate Sep<11>2014 16:57 May 07, 2019 Jkt 247001 ‘‘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 ‘‘Policy Clarification for Certain Fluoroscopic Equipment Requirements’’ 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: Donald Miller, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4318, Silver Spring, MD 20993–0002, 301–796–3299. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 20147 I. Background This guidance document intends to clarify FDA’s interpretation of certain aspects of the performance standard requirements in §§ 1020.30 and 1020.32 (21 CFR 1020.30 and 1020.32) for fluoroscopic equipment. Specifically, it clarifies FDA’s interpretation of fluoroscopic irradiation time (§ 1020.30(b)), the permissible duration of the activation of the x-ray tube in the fluoroscopic mode (§ 1020.32(c)), and on inclusion of an emergency fluoroscopy mode in fluoroscopes. FDA considered comments received on the draft guidance that appeared in the Federal Register of September 25, 2014 (79 FR 57559). 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 ‘‘Policy Clarification for Certain Fluoroscopic Equipment Requirements.’’ 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. Persons unable to download an electronic copy of ‘‘Policy Clarification for Certain Fluoroscopic Equipment Requirements’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document 1806 to identify the guidance you are requesting. 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 have been approved by OMB as listed in the following table: E:\FR\FM\08MYN1.SGM 08MYN1 20148 Federal Register / Vol. 84, No. 89 / Wednesday, May 8, 2019 / Notices Topic 807, subpart E .......................................... 1020 .......................................................... Premarket Notification .................................................................................................. Reporting and Recordkeeping for Electronic Products—General Requirements ....... Dated: May 2, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–09406 Filed 5–7–19; 8:45 am] BILLING CODE 4164–01–P Food and Drug Administration [Docket No. FDA–2018–N–3138] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of an Accelerated Approval Disclosure AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA). SUMMARY: Fax written comments on the collection of information by June 7, 2019. DATES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–NEW and title ‘‘Experimental Study of an Accelerated Approval Disclosure.’’ Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 16:57 May 07, 2019 collection of information to OMB for review and clearance. Experimental Study of an Accelerated Approval Disclosure OMB Control Number 0910–NEW DEPARTMENT OF HEALTH AND HUMAN SERVICES khammond on DSKBBV9HB2PROD with NOTICES OMB control No. 21 CFR part Jkt 247001 I. Background Section 1701(a)(4) of the Public Health Service Act (PHS Act) (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA-regulated products in carrying out the provisions of the FD&C Act. The mission of the Office of Prescription Drug Promotion (OPDP) is to protect the public health by helping to ensure that prescription drug information is truthful, balanced, and accurately communicated so that patients and healthcare providers can make informed decisions about treatment options. The OPDP’s research program supports this mission by providing scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that we believe are most central to our mission, focusing in particular on three main topic areas: advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features, we assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits; focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience; and our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues. This study falls under the topic of advertising features (content and format). Pursuant to section 506(c) of the FD&C Act (21 U.S.C. 356(c)) and 21 CFR part 314, subpart H (or 21 CFR part 601, subpart E for biological products), FDA PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 0910–0120 0910–0025 may grant accelerated approval to a drug product under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) or a biological product under section 351(a) of the PHS Act (42 U.S.C 262(a)). This pathway enables faster approval of prescription drugs intended to treat serious or life-threatening illnesses. Accelerated approval may be based on a determination that a drug product has an effect on a surrogate endpoint (for example, a blood test result) that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit (i.e., an intermediate clinical endpoint). In approving a drug under the accelerated approval pathway, the severity, rarity, or prevalence of a condition, and the availability or lack of alternative treatments, are taken into account. The accelerated approval pathway is limited to certain products intended to treat serious or life-threatening illnesses as there can be ‘‘[u]ncertainty about whether clinical benefit will be verified and the possibility of undiscovered risks’’ (FDA 2014 guidance for industry entitled ‘‘Expedited Programs for Serious Conditions—Drugs and Biologics,’’ available at https:// www.fda.gov/files/drugs/published/ Expedited-Programs-for-SeriousConditions-Drugs-and-Biologics.pdf). Sponsors are generally required to conduct post approval studies to verify and describe the predicted clinical benefit, but those confirmatory studies are not complete at the time that the accelerated approval is granted (Ref. 1). In the event that the required post approval confirmatory studies fail to verify and describe the predicted effect or clinical benefit, a drug’s approval can be withdrawn using expedited procedures. Under FDA’s regulations governing physician labeling for prescription drugs, the INDICATIONS AND USAGE section of the FDA-approved prescribing information (PI) for a drug approved under accelerated approval must include a succinct description of the limitations of usefulness of the drug and any uncertainty about anticipated clinical benefits, with reference to the clinical studies section for a discussion of the available evidence (21 CFR E:\FR\FM\08MYN1.SGM 08MYN1

Agencies

[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20146-20148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09406]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1344]


Policy Clarification for Certain Fluoroscopic Equipment 
Requirements; 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 ``Policy Clarification 
for Certain Fluoroscopic Equipment Requirements.'' This guidance 
document intends to clarify FDA's interpretation of certain aspects of 
the performance standard requirements in FDA's regulations for 
fluoroscopic equipment.

DATES: The announcement of the guidance is published in the Federal 
Register on May 8, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

[[Page 20147]]

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-2014-D-1344 for ``Policy Clarification for Certain Fluoroscopic 
Equipment Requirements.'' 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.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 
``Policy Clarification for Certain Fluoroscopic Equipment 
Requirements'' 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: Donald Miller, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4318, Silver Spring, MD 20993-0002, 301-796-3299.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance document intends to clarify FDA's interpretation of 
certain aspects of the performance standard requirements in Sec. Sec.  
1020.30 and 1020.32 (21 CFR 1020.30 and 1020.32) for fluoroscopic 
equipment. Specifically, it clarifies FDA's interpretation of 
fluoroscopic irradiation time (Sec.  1020.30(b)), the permissible 
duration of the activation of the x-ray tube in the fluoroscopic mode 
(Sec.  1020.32(c)), and on inclusion of an emergency fluoroscopy mode 
in fluoroscopes.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of September 25, 2014 (79 FR 57559). 
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 ``Policy Clarification for Certain 
Fluoroscopic Equipment Requirements.'' 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. 
Persons unable to download an electronic copy of ``Policy Clarification 
for Certain Fluoroscopic Equipment Requirements'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document 1806 to identify the guidance you 
are requesting.

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 have been approved by OMB as listed in 
the following table:

[[Page 20148]]



------------------------------------------------------------------------
                                                            OMB control
          21 CFR part                     Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket Notification.       0910-0120
1020...........................  Reporting and                 0910-0025
                                  Recordkeeping for
                                  Electronic Products--
                                  General Requirements.
------------------------------------------------------------------------


    Dated: May 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09406 Filed 5-7-19; 8:45 am]
 BILLING CODE 4164-01-P
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