[Federal Register Volume 78, Number 172 (Thursday, September 5, 2013)]
[Notices]
[Page 54655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21544]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0477]
Center for Devices and Radiological Health: Draft Standard
Operating Procedure for Level 1, Immediately in Effect Guidance
Documents on Premarket Data Issues; Availability and Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the Draft Standard Operating Procedure (SOP) for Level
1, Immediately in Effect (IIE) Guidance Documents on Premarket Data
Issues. The SOP describes the Center for Devices and Radiological
Health's (CDRH's or the Center's) draft process to clarify and more
quickly inform stakeholders when CDRH has changed its expectations
relating to, or otherwise has new scientific information that could
affect, data submitted as part of an Investigational Device Exemption
(IDE) or premarket submission, including a Premarket Notification
510(k), a Premarket Approval (PMA), or a Humanitarian Device Exemption
(HDE) that needs to be disseminated in a timely manner.
DATES: The Agency encourages interested parties to submit information
and either electronic or written comments by October 21, 2013.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic
access to the document. Submit electronic comments on the draft SOP 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: Philip Desjardins, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5452, Silver Spring, MD 20993-0002, 301-
796-5678, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Task Force on the Utilization of Science in Regulatory Decision
Making (the Task Force) published a Preliminary Report and
Recommendations in August 2010. In the report, the Task Force noted
that when new scientific information changes CDRH's regulatory
thinking, it has been challenging for the Center to communicate the
change and its basis to all affected parties in a meaningful and timely
manner. The Task Force recommended that the Center make use of more
rapid tools for broad communication on regulatory matters, including
establishing a standard practice for communicating to all manufacturers
of a particular group of devices for which the Center has changed its
regulatory expectations on the basis of new scientific information.
Currently, manufacturers typically learn of changes CDRH implements
regarding what data or how to gather specific data in support of an IDE
or premarket submission, including a Premarket Notification 510(k), a
PMA, or an HDE at the time of or soon after a decision is made through
individual engagement with the Center, often not until after they have
prepared that submission. Reviewers may implement these changes, such
as requesting new clinical data or using a new test method, on a case-
by-case basis, with immediate supervisory concurrence when it is
necessary to protect the public health. For example, a reviewer may
request that sponsors test their implantable device for durability
because new data demonstrate that this type of device is prone to
failure due to premature wear and tear of the technology. Although CDRH
may issue a detailed guidance document, the document may not be
published until a year or more after a Branch- or Division-level
decision has been made to request the information because of the
resource constraints in developing guidance documents.
CDRH believes that timely communication with industry about changes
in premarket regulatory expectations is important. FDA's Good Guidance
Practices regulation provides a mechanism for communicating and
implementing certain changes in regulatory expectations quickly,
without requiring prior public comment. Under 21 CFR 10.115(g)(2), FDA
may issue a Level 1, IIE Guidance Document when prior public
participation is not ``feasible or appropriate.'' Under these
circumstances, CDRH intends to use the procedures described in Sec.
10.115(g)(2) to issue guidance documents addressing changes in
premarket regulatory expectations. CDRH has developed this SOP to
facilitate issuance of such guidance documents.
On July 21, 2011 (76 FR 43693), CDRH issued a Standard Operating
Procedure for ``Notice to Industry'' Letters, which outlined a similar
process to clarify and quickly inform stakeholders of new CDRH
expectations (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259172.pdf). After
considering the comments received on that proposal, CDRH is now
announcing a draft SOP that meets the Center's needs and addresses
concerns raised regarding the original ``Notice to Industry'' proposal.
II. Electronic Access
Persons interested in obtaining a copy of the draft SOP may do so
by using the Internet. The Draft Standard Operating Procedure for Level
1, Immediately in Effect Guidance Documents on Premarket Data Issues is
available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259172.pdf. The draft
SOP is also available from http://www.regulations.gov and can be
located using the docket number found in brackets in the heading of
this document.
III. 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: August 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21544 Filed 9-4-13; 8:45 am]
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