Document ID: FDA-2011-N-0070-0036
Agency: fda
Document Type: Proposed Rule
Title: Withdrawal of the Laser Products; Proposed Amendment to Performance
Standard and the Electronic Submission of Labeling for Certain Home-Use Medical Devices
Posted Date: 2018-11-01T04:00Z

[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)]
[Proposed Rules]
[Pages 54891-54892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23916]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 807, 1002, 1010, and 1040

[Docket Nos. FDA-2011-N-0070 and FDA-2016-N-2491]
RIN 0910-AG79 and 0910-AF87

Withdrawal of the Laser Products; Proposed Amendment to 
Performance Standard and the Electronic Submission of Labeling for 
Certain Home-Use Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA, Agency, we) is

[[Page 54892]]

announcing the withdrawal of two proposed rules that published in the 
Federal Register. These proposed rules are not currently considered 
viable candidates for final action. FDA is taking this action because 
these proposed rules need to be reconsidered based on public comments 
received and new information developed after the publication of the 
proposed rules.

DATES: As of November 1, 2018, the proposed rules published on June 24, 
2013, at 78 FR 37723, and October 17, 2016, at 81 FR 71415 are 
withdrawn.

ADDRESSES: For access to the docket, 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.

FOR FURTHER INFORMATION CONTACT: Madhusoodana Nambiar, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 5518, Silver Spring, MD 20993-0002, 
301-796-5837, [email protected].

SUPPLEMENTARY INFORMATION: In 1990, FDA began a process of periodically 
conducting comprehensive reviews of its regulation process, including 
reviewing the backlog of proposed rulemakings that had not been 
finalized. As FDA removed many proposed rules not finalized, the Agency 
implemented a process of reviewing existing proposed rules every 5 
years.
    As part of this process and the Agency's regulatory reform 
initiative, we continue to conduct reviews of existing proposed rules. 
The review determines if the proposals are outdated, unnecessary, or 
should be revised to reduce regulatory burden while allowing FDA to 
achieve our public health mission and fulfill statutory obligations.
    As part of these efforts, FDA is withdrawing the following proposed 
rules:

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                                        Publication date,
       Title of proposed rule           Federal Register           Docket No.           Reason for withdrawal
                                            citation
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1. Laser Products; Proposed          June 24, 2013, 78 FR    FDA-2011-N-0070.......  The proposed rule
 Amendment to Performance Standard.   37723.                                          referenced an
                                                                                      international performance
                                                                                      standard. That
                                                                                      international standard is
                                                                                      now being revised to
                                                                                      reflect advancements in
                                                                                      technology. FDA wants to
                                                                                      have the most current
                                                                                      international standard as
                                                                                      a reference before
                                                                                      publishing a final rule on
                                                                                      laser products.
2. Electronic Submission of          October 17, 2016, 81    FDA-2016-N-2491.......  Several adverse comments
 Labeling for Certain Home-Use        FR 71415.                                       challenged the proposed
 Medical Devices.                                                                     FDA-managed labeling
                                                                                      database as being unduly
                                                                                      burdensome on both FDA and
                                                                                      on industry, without
                                                                                      efficiently enhancing
                                                                                      public health.
                                                                                      Additionally, concerns
                                                                                      regarding the proposed
                                                                                      format and potential costs
                                                                                      for industry to fully
                                                                                      implement were also
                                                                                      raised. Based on the
                                                                                      adverse comments, this
                                                                                      rulemaking would benefit
                                                                                      from being withdrawn at
                                                                                      this time and
                                                                                      reconsidered. The Agency
                                                                                      plans to reconsider its
                                                                                      approach and solicit
                                                                                      further public input at a
                                                                                      future date.
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    The withdrawal of these proposals identified in this document does 
not preclude the Agency from reinstituting rulemaking concerning the 
issues addressed in the proposals listed in the chart. Should we decide 
to undertake such rulemakings in the future, we will re-propose the 
actions and provide new opportunities for comment. Furthermore, this 
withdrawal of the proposed rules is only intended to address the 
specific actions identified in this document, and not any other pending 
proposals that the Agency has issued or is considering. If you need 
additional information about the subject matter of the withdrawn 
proposed rules, you may review the Agency's website (https://www.fda.gov) for any current information on the matter.

    Dated: October 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23916 Filed 10-31-18; 8:45 am]
 BILLING CODE 4164-01-P