Panel Report and Recommendations on PMA Approvals #P86-5 (blue book memo) (Text Only)

This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer 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. This guidance will be updated in the next revision to include the standard elements of GGP’s.

PMA Guidance Memorandum #P86-5

April 18, 1986



Panel Report and Recommendations on PMA Approvals

Purpose

This guidance memorandum clarifies what constitutes a "panel report and 
recommendation" under Section 515(c)(2) of the Food, Drug, and Cosmetic 
Act (the Act).

Problem

On August 16, 1984 the United States Court of Appeals issued an opinion 
in General Medical Co. vs. FDA  that the panel review procedures we 
previously used in considering the reclassification of a new device did 
not meet the requirements of Section 513(f)(2) of the Act.  Specifically, 
the court held that our process for obtaining a panel recommendation and 
a summary of the reasons for the recommendation, i.e., using the 
transcript of the general panel discussion as the panel report, did not 
fulfill the statutory requirement.

Although the General Medical Co. case dealt with a reclassification under 
Section 513(f)(2) and not a new device approval under Section 515(c)(2), 
the language of these sections is similar and the court's analysis and 
logic can be applied to advisory committee recommendations on PMAs. 
Accordingly, the Office of General Counsel had recommended that we revise 
our procedures on PMAs in light of this decision.

New Procedure

In order to comply with the holding in General Medical Co., we have 
developed a new procedure to be used in obtaining panel recommendations 
on PMAs.  As before, we shall conclude a Panel's consideration of a PMA 
with a vote on the Panel's recommendation, but we will now augment the 
voting procedure with a more formal enumeration of the reasons and basis 
for the recommendation.  This will take place during the Panel meeting 
and it will be recorded in the transcript of the Panel meeting.  
Attachment A contains the format and language that can be used by the 
Panel Chairperson to accomplish this goal.  If necessary, this portion
of the transcript could be reproduced separately, verbatim, as the 
Panel's report and recommendations.  If a particular approval is more 
controversial than most, and may be disputed, the Executive Secretary and 
Chairperson should consider preparing a conventional written summary for 
adoption by the Panel.  The Office of General Counsel has agreed to these 
procedures.  See Attachment B.

Effective Date

This policy and procedure is effective immediately.

Attachments A & B

Attachment A

[NOTE:  After an application has been raised for consideration by the 
Panel, presentations have been made, and the Panel has discussed the 
application, the Chairperson should determine the Panel's recommendation 
and the reasons or basis for the recommendation, as follows.]

Chairperson:  We will now consider the Panel's Report and Recommendations 
              respecting approval of the premarket approval application 
              [state the PMA file number], together with the reasons or 
              basis for the recommendation, as required by Section 
              515(c)(2) of the Act. The underlying data supporting the 
              recommendation consist of the information and data set 
              forth in the application itself, the written data summary 
              prepared by FDA staff, the presentations made to the Panel, 
              and the discussions held during the Panel meeting, which 
              are set forth in this transcript.  The recommendation of 
              the Panel will be approval, approval upon conditions that 
              are to be met by the applicant, or denial of approval.

        o     Will all those in favor of approval raise their hands.  
              [PAUSE].  Those in favor of approval are: [state their 
              names].

        o     Will all those in favor of approval with conditions raise 
              their hands.  [PAUSE.]  Those in favor of approval with 
              conditions are: [state their names].

        o     Will all those in favor of denial of approval raise their 
              hands.  [PAUSE].  Those in favor of denial of approval are:
              [state their names].

              The recommendations of the Panel is: [state the majority 
              position]. If the recommendation is conditional approval, 
              identify the conditions and state them.

              The Panel members in favor of [state the majority position, 
              i.e., approval, approval upon conditions, or denial of 
              approval] will now give the reasons or basis for their 
              recommendation.

              [Poll majority members for their reasons for the decision.]

Panel Member;

Panel Member:

[Etc.:]

Chairperson:  [If appropriate.}  The Panel members in favor of [state the 
              minority position] will now give the reasons or basis for 
              the minority report and recommendations. [Poll minority 
              members for the reasons for their position.]

Panel Member:

Panel Member:

[Etc.:]

Chairperson:  This concludes the Report and Recommendations of the Panel 
              on the PMA [state the PMA file number].

ATTACHMENT B 
March 28, 1986

From:  Thomas Scarlett GCF-1

Panel Report and Recommendations Under Section 515(c)(2) of the Act

To:  Kshitij Mohan HFZ-400

        In Attachment B to your March 24 memorandum you propose a 
procedure in response to the Court of Appeals' decision in the 
General Medical case.  The procedure, although short of what the court 
was thinking about in its opinion, goes enough beyond past practice, 
1/ and in the direction the court had in mind, that it can be regarded 
as constituting compliance with the statute.  The procedure has the 
advantage of focusing on the idea of a consensus recommendation, and 
provides an opportunity for the panel members to give a summary of the 
basis for their positions.  A written recommendation could consist of 
the same elements, i.e., the statute does not require a "collegial" 
statement of the panel's reasoning.  I believe, therefore, that the 
proposed procedure can be characterized as providing the required 
"report" and recommendation."  A court might disagree, and you should 
note the statement in the General Medical opinion that the statute is 
not satisfied "even if ... the participants are asked to summarize 
their views at the end of the proceeding."

        I would add the following:

             o  I suggest that the written data summaries that 
                are prepared in advance by Division staff be 
                expressly relied on by panel members as part of 
                their decision.  In that way, the summaries can be 
                regarded as part of the recommendations.

             o  If a particular approval is more controversial than 
                most, and may be disputed, the Center should 
                consider preparing a conventional written summary 
                for adoption by the panel. 
                

                               
         1/Your memorandum questions why it's necessary to fix             
         something hat isn't broken.  The DC Circuit Court of
         Appeals has concluded that the procedure is broken, and 
         although you and I may disagree, the Court of Appeals 
         outranks both of us.


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