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U.S. Department of Health and Human Services

Medical Devices

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PMA Compliance Program #P91-3 (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 #P91-3

 

May 3, 1991
         

                              
PMA Compliance Program
         
Purpose
        
The purpose of this guidance memorandum is to make available to 
ODE reviewers an interoffice agreement regarding Office of Device 
Evaluation (ODE)/Office of Compliance and Surveillance (OCS) roles 
in supporting the PMA compliance program.  It outlines each 
office's responsibility for the implementation of the PMA 
compliance program.
         
Background
         
As part of an Agency-wide initiative to improve the premarket 
assessment of new products, the OCS with the cooperation of the 
ODE has developed a new compliance program entitled "Medical 
Device Premarket Approval Inspections."  This compliance program 
was cleared by the Office of Regulatory Affairs on November 7, 
1990.  On April 15, 1991, the Office of Device Evaluation and the 
Office of Compliance and Surveillance entered into an interoffice 
agreement (attached) concerning the respective roles of ODE and 
OCS under this new compliance program.  While the agreement does 
not have a direct impact on review divisions, it is important for 
all ODE managers and reviewers to understand our office 
responsibilities and to recognize the impact that the PMA 
compliance program has on the PMA evaluation process.  It is for 
these reasons that I am requesting that you take a few moments to 
familiarize yourself with the content of the agreement.
         
Any questions from the regulated industry regarding the PMA 
compliance program, other than questions relating to ODE 
procedures and responsibilities, should be referred to OCS for 
resolution.  If you have questions regarding any aspects of the 
interoffice agreement or how the agreement will impact upon the 
applications in your division, please see your division's PMA 
contact person in the Program Operations Staff.
        
Effective Date
     
This policy is effective immediately.
    
Acting Director, Office of Compliance and Surveillance (HFZ-300)

Interoffice Agreement Regarding ODE/OCS Roles in Supporting the 
PMA Compliance Program

As part of an Agency-wide initiative to improve the premarket 
assessment of new products, the Office of Compliance and Surveillance 
(OCS) with the cooperation of the Office of Device Evaluation (ODE) 
has developed a new compliance program entitled "Medical Device 
Premarket Approval Inspections."  This compliance program was cleared 
by the Office of Regulatory Affairs on November 7, 1990.  It directs 
the field to consider the extent to which the firm has established a 
formal quality assurance program, with emphasis on ensuring that the 
approved design is properly translated into specifications via process 
validation.  If the compliance program is to operate satisfactorily, 
the ocs and the ode must provide administrative, technical support, 
and direction to the field.

Under the PMA regulation, sponsors are required to submit detailed 
information describing the manufacture of the PMA device.  If this 
requirement was rigorously enforced, most PMA applications currently 
under review would be considered deficient.  In the next few weeks,
ODE will be sending to sponsors a document which will provide guidance 
outlining the information that must be included in the manufacturing 
sections of PMA applications.  Although not formalized in the attached 
Interoffice Agreement, we have agreed to allow sponsors a 90-day grace 
period to adjust to the "new" requirements for manufacturing 
information.  

Please review the attached agreement and indicate your 
concurrence/nonconcurrence.


                            Ronald M. Johnson

Attachment

INTEROFFICE AGREEMENT REGARDING ODE/OCS ROLES IN SUPPORTING THE PMA 
COMPLIANCE PROGRAM

On December 4, 1989, the Associate Commissioner for Regulatory 
Affairs, with the concurrence of the Compliance Policy Council, 
directed all Center Directors to develop and implement procedures, "to 
assure that new products are approved only after full consideration of 
field inspectional findings."  One of the goals of this New Products 
Approval Action Plan required that CDRH develop a Premarket Approval 
Compliance Program, which would provide to the field guidance for 
assessing a sponsor's capability to manufacture a PMA device.  The 
goal also required that the compliance program should be consistent 
with the new product approval compliance programs issued by the other 
centers in FDA.

The purpose of this document is to set forth the respective roles of 
the Office of Compliance and Surveillance (OCS) and the Office of 
Device Evaluation (ODE) in regard to the review of the manufacturing 
sections of premarket approval applications, premarket approval 
inspection reports and postmarket approval inspection reports.

ODE has the lead responsibility for the review of the entire PMA 
application.  The role of OCS is to act as technical support in the 
manufacturing and quality assurance area. To fulfill that role, OCS 
conducts a prefiling review of the PMA manufacturing section to assure 
that it describes the manufacturing and quality assurance systems in 
sufficient detail to determine if a GMP program is established, issues 
inspection assignments to the field, and reviews the inspection 
reports to assure that the sponsors have the capability to manufacture 
the PMA device, and are in compliance with the requirements of the GMP 
regulation.

OFFICE OF DEVICE EVALUATION (ODE)

o   ODE receives the PMA applications submitted by the sponsors.  The  
    applications are either original PMA applications, or PMA supplements. 
o  Within three days after completing the initial pre-filing revie
    of a PMA application, ODE will provide to OCS/DCP those sections 
    of the application that pertain to manufacturing, labeling and 
    device characteristics.  

o   When notified by OCS that the manufacturing sections of an 
    application is inadequate, ODE will determine if it is necessary 
    to contact the sponsor, via a Deficiency Letter, and request the 
    missing manufacturing information.  Upon receipt of such 
    information, ODE will forward the information to OCS for review.  
    If ODE decides that no Deficiency Letter is necessary, it will 
    notify OCS. 

o   ODE will notify OCS within three days after filing a PMA 
    application.

o   ODE may, on its own initiative, choose to approve a PMA 
    application without an evaluation of the manufacturing by OCS. If 
    and when ODE anticipates such an approval, ODE will notify OCS 
    immediately so that OCS can cancel any inspection assignment, and 
    notify the district that the PMA will be approved without an 
    inspection.  

o   In order to ensure continuity in reviews and inspectional 
    coverage, ODE will provide to OCS PMA supplements describing 
    changes in design and manufacturing, for use by the field during 
    the post-approval inspections.

THE OFFICE OF COMPLIANCE AND SURVEILLANCE (OCS)

o   Before ODE files an application, OCS will review the 
    manufacturing, labeling, and appropriate device characteristics 
    information to determine whether the application contains 
    sufficient information for an evaluation of the sponsor's
    capability to manufacture the PMA device.

o   OCS will notify ODE of significant deficiencies in the submission 
    that may prohibit filing. 

o   OCS will review additional information submitted by a sponsor in 
    response to a Deficiency Letter.  If necessary, deficiencies will 
    again be identified for ODE.

o   OCS may conclude that a pre-approval inspection is required if any 
    of the following conditions are found:

    -  It is determined from OCS's search of the GWQAP data base that 
       an inspection of the facility has not taken place within the 
       last two years.

    -  That an inspection was conducted, but did not cover a similar 
       process and product.

    -  That an inspection was conducted and the district decision was 
       VAI-3 or OAI.
 
o   If OCS concludes that a pre-approval inspection is required, OCS 
    will issue an inspection assignment to the district where the 
    manufacturing facility is located, and will include with the 
    assignment the complete manufacturing section, labeling 
    information, and device characteristics package.  OCS will issue 
    the inspection assignment only after the PMA application has been 
    filed by ODE.

o   When OCS receives  the Establishment Inspection Report (EIR) from 
    the District, OCS will review the report and any district 
    recommendations.

o   Based upon the review, OCS will notify ODE that the manufacturing 
    and quality assurance systems used for the PMA device and either 
    approvable or not approvable.  OCS will also send a "Feedback" 
    letter to the District indicating CDRH's concurrence or 
    nonconcurrence with the District's recommendation and identifying 
    specific concerns to be followed up during the post-approval 
    inspection.

o   When no assignment for a pre-approval inspection is issued, OCS 
    will forward a FAX memorandum to the appropriate District Director 
    notifying the District that CDRH intends to approve the facility 
    unless information to the contrary is received within 10 working 
    days.

o   After notification from ODE that the firm's PMA application is 
    ready for final approval, OCS will be responsible for checking the 
    OAI Alert database to confirm that the firm remains in compliance.  

    OCS will also notify the appropriate District when the PMA 
    application is ready for final approval.

o   When receiving a response from the District Director advising that 
    the facility under consideration is not approvable, or that 
    approval should be delayed, OCS will issue a memorandum to ODE 
    advising that the PMA should not be approved until the District's 
    concerns are resolved.

o   If the District's recommendation is other than approvable, OCS 
    will decide what course of action to take regarding resolution of 
    the District's concern.

o   If ODE has received PMA supplements for changes in the design, 
    labeling or manufacturing process, OCS will evaluate the adequacy 
    of such changes and identify potential problems.  OCS will relay 
    the required information to the District as soon as possible for 
    use in conducting post-approval inspections.

Upon receipt of the Post Approval EIR, OCS will review all comments 
made and notify the District and ODE of any regulatory action 
indicated.

                                              
Ann B. Holt, DVM                       

Concur                   Nonconcur                   Date                       
                          
Robert L. Sheridan

Concur                   Nonconcur                   Date                

Walter E. Gundaker

Concur                   Nonconcur                   Date