E6-18553. Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on premarket notification.

DATES:

Submit written or electronic comments on the collection of information by January 2, 2007.

ADDRESSES:

Submit electronic comments on the collection of information to: http://www.fda.gov/​dockets/​ecomments. 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.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION:

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, including each proposed extension of an existing 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.

Premarket Notification—21 CFR Part 807; Subpart E—(OMB Control Number 0910-0120)

Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(k)) and the implementing regulation under part 807 (21 CFR part 807, subpart E) require a person who intends to market a medical device to submit a premarket notification submission to FDA at least 90 days before proposing to begin the introduction, or delivery for introduction into interstate commerce, for commercial distribution of a device intended for human use. Based on the information provided in the notification, FDA must determine whether the new device is substantially equivalent to a legally marketed device, as defined in § 807.92(a)(3). If the device is determined to be not substantially equivalent to a legally marketed device, it must have an approved premarket approval application (PMA), Product Development Protocol or be reclassified into class I or class II before being marketed. The FDA makes the final decision of whether a device is equivalent or not equivalent.

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250) added section 510(o) to the act to establish new regulatory requirements for reprocessed single-use devices (SUDs). MDUFMA was signed into law on October 26, 2002.

Section 510(o) of the act requires that FDA review the types of reprocessed SUDs subject to premarket notification requirements and identify which of these devices require the submission of validation data to ensure their substantial equivalence to predicate devices. Section 510(o) also requires that FDA review critical and semicritical reprocessed SUDs that are currently exempt from premarket notification requirements and determine which of these devices require the submission of premarket notifications to ensure their substantial equivalence to predicate devices.

FDA has identified the reprocessed SUDs that require the submission of validation data to date. The requirement to submit validation data for certain reprocessed SUDs has been incorporated into the premarket notification program. As with all other devices, new premarket notifications for reprocessed SUDs will be required as new manufacturers enter the market or manufacturers with cleared premarket notifications make significant changes to their device. The burden estimates below include the burden for submitting premarket notifications for reprocessed SUDs with the burden for all other devices. FDA may amend the lists of reprocessed SUDs that require the submission of premarket notifications with validation data as necessary.

Section 807.81 states when a premarket notification is required. A premarket notification is required to be submitted by a person who is:

• Introducing a device to the market for the first time;
• Introducing or reintroducing a device which is significantly changed or modified in design, components, method of manufacturer, or the intended use that could affect the safety and effectiveness of the device.

Section 807.87 specifies information required in a premarket notification submission.

Section 204 of the Food and Drug Administration Modernization Act (FDAMA) amended section 514 of the act (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions including premarket notifications or other requirements. FDA has published and updated the list of recognized standards regularly since enactment of FDAMA and has allowed 510(k) submitters to certify conformance to recognized standards to meet the requirements of § 807.87. Certification of conformance to a recognized standard may allow a manufacturer to submit an abbreviated 510(k). FDA is now seeking approval of a form (Form FDA 3654) that will standardize certification of conformance to a recognized standard. FDA believes that use of this form will simplify the certification process for 510(k) submitters and the review process for FDA.

Form FDA 3514, a summary cover sheet form, has been created to assist respondents in categorizing 510(k) information for submission to FDA. This form also assists respondents in categorizing information for other FDA medical device programs such as PMAs, investigational device exemptions, and humanitarian device exemptions. The total burden (1,000 hours) for Form FDA 3514 has been included in this information collection. Form FDA 3654 is used in the following information collections: 0910-0078, 0910-0231, and 0910-0332, but the burden is approved under this information collection (0910-0120).

Under § 807.87(h), each 510(k) submitter must include in the 510(k) either a summary of the information in the 510(k) (510(k) summary) or a statement certifying that the submitter will make available upon request the information in the 510(k) (510(k) statement). If the 510(k) submitter includes a 510(k) statement in the submission, § 807.93 requires that the official correspondent of the firm make available within 30 days of a request all information included in the submitted premarket notification on safety and effectiveness. This information will be provided to any person within 30 days of a request if the device described in the premarket notification submission is determined to be substantially equivalent. The information provided will be a duplicate of the premarket notification submission including any safety and effectiveness information, but excluding all patient identifiers and trade secret and confidential information.

The most likely respondents to this information collection will primarily be medical device manufacturers including reprocessors of SUDs, and initial importers of devices.

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

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section	Form FDA Number	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
807, subpart E (807.81 and 807.87/510(k))		3,700	1	3,700	80	296,000
	3514	2,000	1	2,000	0.5	1,000
	3654	150	1	150	1	150
Totals						297,150
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.—Estimated Annual Recordkeeping Burden¹

21 CFR Section	Form FDA Number	No. of Recordkeepers	Annual Frequency per Recordkeeping	Total Annual Records	Hours per Recordkeeper	Total Hours
807.93		2,000	10	20,000	0.5	10,000
Total						10,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA has based these estimates on conversations with industry and trade association representatives, and from internal review of the documents listed in tables 1 and 2.

Dated: October 30, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.