FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
| FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
PMA Compliance Program
|
 |
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.
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
Updated 5/29/1996
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH