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Agency Information Collection Activities; Proposed Collection; Comment Request; Invitation to Manufacturers and Distributors to Voluntarily Submit Final Product Labeling and Information Electronically for all Devices Cleared by the Food and Drug Administration for Home Use; Notice of Pilot Program

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments regarding the request that manufacturers and distributors of all devices cleared by FDA for home use voluntarily submit final product labeling and information electronically as a part of a pilot program to be conducted by FDA's Center for Devices and Radiological Health (CDRH). FDA is requesting that manufacturers and distributors for these products submit final product labeling and information in a standard Structured Product Labeling (SPL) format that we intend to eventually place on a home use device product portal that will be accessible to the public.


Submit written or electronic comments on the collection of information by July 19, 2010.


Submit electronic comments on the collection of information to Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

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Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156,

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Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44.U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Invitation to Manufacturers and Distributors of Devices Cleared by FDA for Home Use to Voluntarily Submit Final Product Labeling and Information Electronically (OMB Control Number 0910—New)

For purposes of this pilot program, FDA generally considers a home use device to be a medical device intended for users in a non-clinical environment that is managed partly or wholly by the user, where the device may require adequate labeling for home use and may require training by a licensed heath care provider in order to be used safely and effectively.

In June 2001, FDA created the Center for Devices and Radiological Health (CDRH) Home Health Care Committee (HHCC) to review CDRH's involvement in addressing problems that arise when devices are used in the home environment. After meeting with various stakeholders, the HHCC agreed with the stakeholders' recommendation that promoting the safe use of medical devices presented a significant health challenge for which the HHCC could focus CDRH's educational outreach efforts. As a result, FDA is seeking manufacturers and distributors of devices cleared for home use to voluntarily participate in a pilot program involving the submission of final product labeling and additional product information electronically.

Section 510(j)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(j)(1)(B)(i)), requires persons who register and list a restricted device to provide, among other things, a copy of all labeling to FDA. Section 510(j)(1)(B)(ii) of the act requires persons who register and list a device that is not restricted to provide the label and package insert and a representative sampling of any other labeling to FDA. For this pilot program, we are requesting manufacturers and distributors of medical devices cleared for home use to electronically submit final product labeling as well as the following information, if not included in product labeling:

Device Product Information

Proprietary name

Descriptive name

Model or catalog number

FDA listing number

Manufacturer Information

Manufacturer name

Manufacturer address

Manufacturer 800 number

Manufacturer Web site

Distributor Information

Distributor name

Distributor address

Distributor 800 number

Distributor Web site



Single use or reusable


Storage temperature

Storage humidity


Storage environment

Picture of device

MRI compatible

Marketing Information


Prescription or OTC

Components and Accessories

Components needed to operate the device

Accessories compatible with the device

Pictures of components and compatible accessories

Directions for Use

Intended use of the device

Indications for use

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Summary of safety and effectiveness

Assembly or installation instructions

Calibration instructions

Instructions for use for the layperson




Side effects

Cleaning, disinfecting, and sterilization instructions

Safety information

In Vitro Diagnostic Devices

Test code

Value range

Special information for this test

If this information is not a part of your current final product labeling or information, FDA is requesting that you submit the information as a part of this pilot program. The purpose of the pilot program is twofold. First the pilot program will enable regulated industry to provide feedback that will assist FDA in developing guidance for industry on the electronic submission and availability of final labeling and product information for devices cleared for home use. Second, the pilot program will enable the public and regulated industry to view the information and instructions for use for such devices as a part of CDRH's planned medical device portal for devices cleared for home use. It is our expectation that the portal, established as a part of this pilot program, will increase the likelihood that users—home health nurses, patients, and caregivers—will have continuous access to home use labeling information and instructions for use to help ensure the safe and effective use of devices cleared for home use. In order for manufacturers and distributors to submit final labeling and product information they will need to do so in the SPL format. To create an SPL file and submit it to FDA, a respondent would need the following tools: A computer, appropriate software, access to the Internet, knowledge of terminology and standards, and access to FDA's Electronic Submissions Gateway (ESG) (​ForIndustry/​ElectronicSubmissionsGateway/​default.htm). The ESG is an agency-wide means for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of regulatory submissions. Instructions and information regarding the creation of an SPL file can be found at​ForIndustry/​DataStandards/​StructuredProductLabeling/​default.htm. Most respondents have computers and Internet access available for their use. If a business does not have an available computer or access to the Internet, free use of computers and the Internet are usually available at public facilities, e.g. a community library. In addition there should be no additional cost associated with obtaining the software. In 2008, FDA collaborated with GlobalSubmit (​home/​Home/​tabid/​37/​Default.aspx) to make available free SPL authoring software that SPL authors may utilize to create new SPL documents or edit previous versions. After the SPL is created, the respondent would upload the file through the ESG. The Internet portal can be found at​downloads/​ForIndustry/​FDAeSubmitter/​UCM162419.pdf. Prior to uploading an SPL file, one must obtain a digital certificate. Instructions regarding obtaining a digital certificate used with FDA's ESG and uploading the SPL file for submission can be found at​esg/​default.htm. The digital certificate binds together the owner's name and a pair of electronic keys (a public and a private key) that can be used to encrypt and sign documents. A fee of up to approximately $20.00 is charged for the digital certificate. FDA is not calculating this small fee as cost of this information collection because manufacturers and distributors will have already secured a digital certificate as they are required to do so when they register and list.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden1

ActivityNo. of RespondentsAnnual Frequency per ResponseTotal Annual RespondentsHours per ResponseTotal Hours
Collecting Final Labeling and Product Information200360021,200
Conversion of Word or PDF Final Labeling and Product Information into SPL200360021,200
Submission of SPL into ESG20036001600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA estimates that the collection of final product labeling will take 1 hour per response. FDA estimates that the submission of final product information will also take 1 hour per response. The agency estimates that approximately 200 respondents will submit their device labeling and product information 3 times annually. The agency estimates that it will take respondents 2 hours to convert their word or PDF labeling and product information into an SPL format using SPL authoring software. The main task involved in this conversion is copying the content from one document (Word or PDF) to another (SPL). SPL authors may copy a paragraph from a Word or PDF document and paste the text into the appropriate section of an SPL document. In instances where an SPL author needs to create a table, the table text may be copied from Word or PDF document and pasted into each table cell in the SPL document. Conversion software vendors have designed tools that will import the Word or PDF version of the final labeling and product information, and within minutes, automatically generate the SPL documents. Once the document is in the SPL format device manufacturers can then submit their product labeling through FDA's ESG. The agency estimates the burden associated with entering the SPL labeling and product information into the ESG is 1 hour per response. The agency based its estimates on the number of premarket submissions cleared by FDA for home use from 1976 to the present as well as experience with the electronic submission process of registration and listing data elements.

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Dated: May 12, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2010-11810 Filed 5-17-10; 8:45 am]