2011-18387. Standard Operating Procedure for “Notice to Industry” Letters

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for comments.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the standard operating procedure (SOP) for “Notice to Industry” Letters. The SOP describes the Center for Devices and Radiological Health's (CDRH) 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 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 September 19, 2011.

ADDRESSES:

Submit electronic comments or information 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.

FOR FURTHER INFORMATION CONTACT:

Angela Krueger, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993, 301-796-6380, e-mail: [e-mail].

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 sending “Notice to Industry” Letters to all manufacturers of a particular group of devices for which the Center has changed its expectations for data submitted as part of an IDE or premarket application on the basis of new scientific information.

Currently, manufacturers typically learn of changes CDRH implements at the time of or soon after a decision is made through individual engagement with the Center, often not until after they have prepared a premarket 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 demonstrates 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.

Therefore, CDRH believes that timely communication with industry about changes in regulatory expectations or new scientific information is important. The Task Force recommended that CDRH use “Notice to Industry” Letters in these circumstances, although not required, and adopt a uniform template and terminology for such letters, including clear and consistent language to indicate that the Center has changed its regulatory expectations, the general nature of the change, and the rationale for the change. The Task Force contemplated that CDRH could potentially issue “Notice to Industry” Letters, if such letters constitute guidance, as “Level 1—Immediately in Effect” guidance documents under 21 CFR 10.115(g)(2), and would open a public docket upon their issuance through a notice of availability in the Federal Register.

This SOP was developed to address this recommendation from the Task Force. Where appropriate, CDRH will communicate new expectations as “Notice to Industry” Guidance Letters, which will comply with Good Guidance Practices, or CDRH will communicate other new scientific information as “Notice to Industry” Advisory Letters. The Center will post both types of “Notice to Industry” Letters on its Web site, and will also use additional methods for distributing the Letters to identified stakeholders. When CDRH issues a “Notice to Industry” Guidance Letter concerning a change in premarket expectations that will affect pending submissions, the Center will generally specify an additional amount of time for sponsors of those submissions to address the new issues. Where appropriate, “Notice to Industry” Guidance Letters would be followed as quickly as possible by new or revised guidance explaining the Center's new regulatory expectations (if any) in greater detail and revising the guidance where necessary in response to comments received, so that external constituencies have a fuller understanding of the Center's current regulatory thinking.

II. Submission of Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed 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.

Dated: July 15, 2011.

Nancy K. Stade,

Deputy Director for Policy, Center for Devices and Radiological Health.