Guidance on PMA Interactive Procedures for
Day-100 Meetings and Subsequent Deficiencies 
for Use by CDRH and Industry
This document is intended to provide guidance. It represents the Agencys 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 Kathy M. Poneleit or Lisa C. Fisher, 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 Kathy M. Poneleit or Lisa C.
Fisher at 301-594-2186.
Additional Copies:  World Wide Web/CDRH home page at http://www.fda.gov/cdrh or CDRH Facts
on Demand at 1-800-899-0381 or 301-827-0111, specify number 322 when prompted for the
document shelf number.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration 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.,
PMAs 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
 
1.  There will be identified to the applicant at the time of filing review a contact person on the
review team who will ordinarily be the PMA project manager.  The person will be responsible
for coordinating the project, the interactive review meetings, and status reports.
 
                    
1 This document is intended to provide guidance. It represents the Agencys 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.
Page 1 2.  FDA will provide the applicant with a written description of any deficiencies in the application
that, at that point, have been identified based on an interim review of the entire application and
will identify the information that is required to correct those deficiencies approximately 90
days from the filing date of the PMA.  Minor deficiencies may be identified as well.  This early
communication will occur whether or not the applicant requests a day 100 meeting.  The letter
should be faxed to the applicant either by day 90 in the review cycle or at least 10 days prior
to any day 100 meeting to facilitate a meaningful dialogue with the applicant.
 
3.  The relevant core review team, Branch Chief, and Division Director or Deputy Director will
attend the meeting with the applicant.  Others attendees from FDA will include Program
Operations Staff (POS) and Office management as appropriate.
 
4.  During the meeting the following may occur:
 
  a general discussion of identified issues and discussion of remedial actions,
  a discussion of an action plan with estimated dates of completion,
  a discussion of  FDA estimated timetables for review completion,
  identification of the need for panel involvement,
  a discussion of possible premarket versus postmarket requirements.
 
5.  Draft minutes of the meeting will be distributed to all attendees and the review team leader
will provide the final minutes to the attendees, POS, and the administrative record. 
 
6.  After the day 100 meeting, FDA will continue to communicate promptly with the applicant via
teleconference, fax, videoconference, etc., or in writing the status of the review and what if
any additional information has been identified that is required to achieve completion of the
review and final action on the application.  This continued communication will occur at least
every 4 weeks using any of the above methods until the review is completed.  Minutes or
copies of letters of all such interactions, including teleconferences and videoconferences, will
be made a part of the administrative record.
Page 2