Panel Review of Premarket Approval Applications #P91-2 (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 Memorandum #P91-2

May 3, 1991
           


Panel Review of Premarket Approval Applications

Purpose

The Safe Medical Devices Act of 1990 (SMDA) has provided the Food 
and Drug Administration much needed discretion in the use of 
advisory panels in the review of premarket approval applications 
(PMAs).  The purpose of this memorandum is to establish points to 
consider when deciding whether to take a PMA before an advisory 
panel for review and recommendation.  This memorandum does not 
specifically address the situation in which an applicant 
disagrees with our decision to avoid panel review and requests 
that their PMA be referred to the appropriate panel for a formal 
review and recommendation.

Background

The Medical Device Amendments of 1976 to the Federal Food, Drug, 
and Cosmetic Act required that the agency refer all filed PMAs to 
the appropriate panel established under section 513 for study and 
submission of a report and recommendation respecting approval of 
the application, together with all underlying data and the 
reasons or basis for the recommendation.  This requirement 
applied to all original PMAs, and many supplemental PMAs that 
were believed to pose issues that were analagous to those posed 
by their original counterparts (refer to PMA Memorandum #86-6 in 
the ODE Blue Book).  The law did not overtly recognize the 
agency's ability to effectively evaluate data in any PMA or 
"panel-track" supplement independently without the assistance of 
a panel even when we had the necessary in-house scientific 
expertise or had developed the required expertise from panel 
deliberations on previously reviewed PMAs for similar devices.

Our interpretation of the legal requirements went so far as to 
cause us for years to take original PMAs that were nothing more 
than "licensing agreements"1 to panels for a report and 
recommendation on the approvability of the application.  It was 
not until April 18, 1986 that we developed a policy to eliminate 
redundant panel involvement in the approval of "licensing 
agreements." 

On July 25, 1986, ODE developed a policy regarding panel review 
of PMAs for "me too" devices that was an attempt to meet the 
statutory requirements for panel review and to expedite PMA 
processing (refer to PMA Memorandum #86-6 in the ODE Blue Book).  
Under this directive, we could identify PMAs for "me too" devices 
and develop evaluation criteria that we could employ in 
evaluating the device's safety and effectiveness.  So long as the 
appropriate panel had endorsed our evaluation criteria, we could 
independently apply the criteria to evaluate a PMA without direct 
panel involvement.  Developing these detailed criteria proved to 
be a long and arduous task and too resource intensive to be a 
successful part of the PMA program.

Discussion

Our advisory panels undoubtedly provide much needed expertise in 
the review of the safety and effectiveness of all new medical 
devices.  Clearly, the agency does not have the ability to hire 
and maintain the wide breadth of medical expertise needed to meet 
the challenge of evaluating the rapidly evolving new and 
innovative medical technology.  Consequently, it is essential 
that we maintain an array of competent advisory panels to ensure 
our ability to accomplish our public health mission.

The maintenance and use of advisory panels is not, however, 
without expense.  The cost of convening panel meetings is very 
high when one considers the time and effort expended by various 
agency personnel in preparing for a meeting and the travel and 
per diem costs in bringing experts from around the country to 
Washington, D.C.  Additionally, panel members being recognized 
experts in the fields often must make personal and professional 
sacrifices to attend panel meetings when they are held.
     
1.  Licensing agreements permit a PMA aplicant to obtain approval 
based upon specific agreements with the holder of an approved 
PMA.  Uner such agreements, the basis for the orginal approval 
applied to the "licensing" PMA applicant.

SMDA provides the agency the much needed discretion on when to 
use advisory panels in the review of PMAs.  The new legislation 
provides us the ability to consider factors such as (1) the 
expense of convening a meeting, (2) the legitimate scientific 
needs to properly evaluate a new medical device and (3) the 
agency's ability to meet the needs with in-house expertise when 
deciding whether panel input should be obtained.  This new 
"discretion" that we have been afforded requires that we develop 
criteria to:

1.  ensure internal consistency in decision-making;

2.  clarify our review process to applicants;

3.  ensure that advisory panels are used when they are needed to
    contribute to sound decision-making;

4.  avoid the wasting of panel resources that result from     
    convening panel meetings when they are unnecessary; and

5.  expedite the review process by enabling reviewers to quickly 
    decide if panel involvement is needed.

In order to address the above issues, criteria must be developed 
that will ensure we are justified in convening a panel to review 
a newly submitted PMA.  It is important to note, however, that 
review divisions must evaluate the circumstances specific to each 
PMA and exercise great judgment in determining whether a panel 
review is warranted.  It is impossible to establish criteria that 
will address all of the situations that we encounter in PMA 
review.

Criteria for Panel Involvement

When making the decision to take a PMA before an advisory 
committee, the review division should conclude that

1.  we do not have the knowledge or experience to properly 
    evaluate the types of safety and effectiveness questions 
    posed by the new device without panel input;

2.  the specific PMA raises a new issue that is best addressed by     
    employing the breadth of knowledge and experience afforded by     
    convening an advisory panel meeting; or

3.  the data establishing the clinical performance of the device     
    reveals unanticipated safety and effectiveness questions that     
    would best be addressed through panel deliberations.

Guidance

Divisions are to take all measures required to eliminate 
unnecessary panel involvement in the evaluation of PMAs.  Before 
scheduling a PMA for panel review, divisions are to consult the 
above criteria.  In general, all PMAs for the first-of-a-kind 
device should be taken before the appropriate advisory panel for 
review and recommendation.  As soon as division management 
believes that (1) the pertinent issues in determining the safety 
and effectiveness for the type of medical device are understood 
and (2) they have developed the ability to address those issues, 
future PMAs for devices of that type should not be taken before 
an advisory panel unless a particular application presents an 
issue that can best be addressed through panel review.  Each 
division's management must ensure that the decision to involve, 
or not involve, a panel in the review of each PMA is well 
documented. 

Furthermore, I expect each division's management to be prepared 
to justify panel involvement on all PMAs other than the first 
three PMAs for a new type of device.  Should an applicant 
exercise their rights under SMDA and request that FDA refer their 
PMA to an appropriate panel for a formal review and 
recommendation, the review division is to consider the merits of 
such a request on a case-by-case basis.