E8-143. Guidance for Industry and Food and Drug Administration Staff; The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program.” This guidance provides premarket approval application (PMA) applicants with information about the bioresearch monitoring (BIMO) review process. This includes a BIMO evaluation of clinical and nonclinical information in the PMA and certain PMA supplements as well as preapproval BIMO inspections. The procedural information outlined in this document should help applicants and FDA to better understand the BIMO review and inspection so it can proceed in a timely manner.

DATES:

Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the guidance document entitled “The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments or http://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Matthew J. Tarosky, Center for Devices and Radiological Health (HFZ-300), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-0243.

SUPPLEMENTARY INFORMATION:

I. Background

On October 26, 2002, the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250) was signed into law. Among other things, MDUMFA authorized the collection of user fees to improve the performance and predictability of FDA's device review program, including premarket approval applications (PMAs). One such goal included a commitment to improve the scheduling and timeliness of PMA preapproval inspections. A portion of the user fees collected under MDUFMA will be used to help to cover the costs associated with the bioresearch monitoring (BIMO) program review of a PMA and the performance of any related clinical or nonclinical inspections. This final guidance document supersedes the corresponding draft guidance entitled “The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program,” which was announced in the Federal Register on June 20, 2006 (71 FR 35436 through 35437).

The comment period for the draft guidance closed on September 18, 2006. During this time, FDA received one set of comments from a device manufacturer concerning the draft guidance. Some of the comments suggested combining the BIMO and manufacturing preapproval inspections. FDA did not make changes in response to these comments because preapproval BIMO and manufacturing inspections can not be performed at the same time. Compared to the preapproval manufacturing inspection program, the BIMO program has different objectives, usually involves inspections of different sites, and FDA investigators with different expertise. FDA did modify the guidance to respond to comments that requested further information about criteria for selecting inspection sites and determining when followup actions are necessary.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on “The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

III. Electronic Access

Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive “The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program,” you may either send an e-mail request to [e-mail] to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1602 to identify the guidance you are requesting.

CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at http://www.fda.gov/​cdrh. A search capability for all CDRH guidance documents is available at http://www.fda.gov/​cdrh/​guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at http://www.fda.gov/​ohrms/​dockets.

IV. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 USC 3501-3520). The collections of information in 21 CFR part 814 have been approved under OMB Control Number 0910-0231.

V. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES), written or electronic comments regarding this document. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Dated: December 20, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.