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. \s\