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This document is intended to provide guidance. It represents the Agency's current thinking on the above. 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, regulations, or both.
PMA Staff, Office of Device Evaluation
Document issued on: February 19, 1998
Until May 26, 1998, comments and suggestions regarding this document should be submitted to Docket No. 98D-0079. Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 12420 Parklawn Drive (HFA-305), Room 1-23, Rockville, MD 20857. Such comments will be considered when determining whether to amend the current guidance.
After May 26, 1998, comments and suggestions may be submitted at any time for Agency consideration to Thinh Nguyen, 9200 Corporate Blvd, HFZ-402, Rockville, MD 20850. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance contact Thinh Nguyen at 240-276-4010.
Additional Copies: World Wide Web/CDRH home page at http://www.fda.gov/cdrh or CDRH Facts
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document shelf number.
Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies for Use by CDRH and Industry
Background/Purpose
The FDA Modernization Act of 1997 (Pub. L. 105-115) added new section 515(d)(3) to the FD&C Act. This section requires FDA, upon written request, to meet with the applicant no later than 100 days after the receipt of a PMA application that has been filed. The purpose of the meeting is to discuss the review status of the application. With the concurrence of the applicant, a different schedule may be established. The section also states that, prior to the meeting, FDA is to inform the applicant in writing of any identified deficiencies and what information is required to correct those deficiencies. FDA must also promptly notify the applicant if it identifies additional deficiencies or any additional information required to complete agency review. This guidance1 describes the procedures to be used to implement this interactive review provision. The guidance applies to original PMA applications received by FDA on or after February 19, 1998. While FDA will honor requests for review status meetings from applicants with pending submissions (i.e., PMA's submitted prior to February 19, 1998), the timing for such meetings will vary depending on the review status of the individual application.
The Meeting Request
The meeting request should be submitted with the PMA or as an amendment to the PMA no later than 70 days from FDA receipt of the PMA accepted for filing or 70 days from submission of the amendment making the PMA filable ("filing date"). This 30 day lead time is needed to allow FDA sufficient time to schedule the meeting. In the written request, the applicant should specify the type of meeting desired, e.g., face-to-face, teleconference, or videoconference, provide a list of the persons who will attend for the company, and identify several possible dates for the meeting. After a letter filing the application has been issued, the reviewing division will contact the applicant to set up the meeting if requested. As provided by the statute, FDA and the applicant may, by mutual consent, establish a different time for the "day 100" meeting.
Meeting Preparation and Documentation, Follow-Up
1This document is intended to provide
guidance. It represents the Agency's current thinking on the above. 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, regulations, or both.
Guidance Pertaining to the FDA Modernization Act
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