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This document is intended to provide guidance. It represents the Agency's current thinking on the above. It does not create or confer any 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.
Office of Device Evaluation
Document issued on: February 19,1998
Until May 26, 1998, comments and suggestions regarding this document should
be submitted to Docket No. 98D-0080. Dockets Management Branch, Division of
Management Systems and Policy, Office of Human Resources and Management Services,
Food and Drug Administration, 12420 Parklawn Drive (HFA-305), Room 1-23, Rockville,
MD 20857. Such comments will be considered when determining whether to amend
the current guidance.
After May 26, 1998, comments and suggestions may be submitted at any time for
Agency consideration to, Kathy M. Poneleit, 9200 Corporate Blvd, HFZ-402, Rockville,
MD 20850. Comments may not be acted upon by the Agency until the document is
next revised or updated. For questions regarding the use or interpretation of
this guidance contact Kathy M. Poneleit at 301-594-2186 or Walter W. Morgenstern
at 301-594-4699.
Additional Copies: World Wide Web/CDRH home page at http://www.fda.gov/cdrh
or CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number 795
when prompted for the document shelf number.
30-Day Notices and 135-Day PMA Supplement Points-of-Contact
ODE | OC | |||||
Division | Contact | Phone |
Division | Contact | Phone |
|
DCLD | Joe Hackett | 594-3084 | DOE I | Jerry Kirk | 594-4591 Ext 153 |
|
DCRND | Steve Turtil | 443-8320 | DOE II | James Woods | 594-4613 Ext 105 |
|
DDIGD | Pat Cricenti | 443-8879 Ext 169 |
DOE III | Gladys Rodriguez | 594-4646 Ext 153 |
|
DRGD | Pauline Fogarty | 594-1184 | ||||
DOD | Debra Falls | 594-2205 | ||||
DRAERD | Pat Miller or Leah McGee |
594-5072 Ext 149 594-2080 |
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Devices and Radiological Health
Rockville, MD 20850
30-Day Notices and 135-Day PMA Supplements
for
Manufacturing Method or Process Changes,
Guidance for Industry and CDRH
30-Day Notices and 135-Day PMA Supplements
New section 515(d) (6) of the act added by the FDA Modernization Act of 1998
(Pub. L. 105-115), provides that PMA supplements are required for all changes
that affect safety or effectiveness unless such change involves modifications
to manufacturing procedures or method of manufacture. Those types of manufacturing
changes will require a 30-day Notice or, where FDA finds such notice inadequate,
a 135-day PMA supplement. The purpose of this guidance1 is to describe
what changes generally will qualify for the 30-day Notice and what changes generally
will not. For those changes in manufacturing that generally will not qualify
for 30-day Notices, FDA requests PMA holders to submit supplemental PMAs or
consult the agency on a case by case basis.
1This document is intended to provide guidance. It represents the Agency's current thinking on the above. It does not create or confer any 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.
What Changes Qualify for Submission of a 30-Day Notice?
Changes that qualify for submission as a 30-day Notice are:
If these changes result in changes in the designed performance specifications,
or the PMA designated physical or chemical specifications of the finished device,
FDA recommends that they be submitted in the form of a 180-day PMA supplement
(as per 21 CFR 814.39). For example, if a manufacturing change in the curing
process causes a device to become opaque but the performance specifications
are for a clear product, a 30-day Notice is not applicable.
Changes that potentially qualify for a 30-day Notice are often intended to:
Examples of manufacturing process or methods changes that would be likely to
qualify for a 30-day Notice include changes in or from:
Changes that qualify for a "Special PMA Supplement - Changes Being Effected"
under 21 CFR 814.39(d)(2) for changes in quality controls or manufacturing process
that add a new specification or test method, or otherwise provide additional
assurance of purity, identity, strength, or reliability of the device can be
submitted either as a "Special PMA Supplement - Changes Being Effected"
or a 30-day Notice at the discretion of the PMA holder.
What Changes Do Not Qualify for Submission of a 30-Day Notice?
Examples of changes that the FDA does not believe qualify for submission of a 30-day Notice include any change in manufacturing needed to accommodate a change in:
FDA recommends that submissions for these nonqualifying changes be in the form
of a 180-day PMA supplement or alternate submission, e.g., Real-Time PMA supplement,
Pilot PMA supplement for a manufacturing site change, etc.
Neither a 30-day Notice nor a PMA supplement is required if the change was
a modification to the manufacturing procedures or method not affecting the safety
and effectiveness of the product.
Contents of 30-Day Notices and 135-Day PMA Supplements
The 30-day Notice should contain the following:
The information to be included in a 30-day Notice is only that necessary to
evaluate the importance of the change, the declaration of conformity to 520(f),
and the information specified above as applicable. More detailed data supporting
the change may be provided in the form of appendices to facilitate the review
process. A 30-day Notice may include all the information needed in a PMA supplement.
Should it be necessary to evaluate the change as a 135-day PMA supplement,
the information to be submitted is as specified in 21 CFR 814.39(c).
Submissions for manufacturing procedures or method of manufacturing which qualify
for review as a 30-Day Notice may not include requests for approval of other
types of changes. Submissions which contain device design, labeling changes,
etc., in the same submission as the manufacturing changes will be automatically
placed in the 180-day review queue.
Action on a 30-Day Notice or 135-Day PMA Supplement
If the change qualifies as a 30day Notice as described above, the change may be made 30 days after FDA receives the 30day notice unless FDA informs the PMA holder within that 30 day period that the 30-day Notice is not adequate and describes the additional information or action required.
FDA will find a 30-day Notice not adequate if a detailed review of the data supporting the change must be performed.
If the 30-day Notice was not adequate, but contained data meeting appropriate content requirements for a PMA supplement, then the 30-day Notice will become a 135-day PMA supplement with the time spent reviewing the 30-day Notice subtracted from the 135 day review clock. The applicant must be informed in writing of the need to review the submission as a 135-day PMA Supplement and any additional data required to complete the review. This correspondence will issue within 30 days of receipt of the 30-day Notice.
If the 30-day Notice was not adequate and did not contain data meeting appropriate
content requirements for a PMA supplement, the applicant will be informed that
the 30-day Notice is not approved. The letter will either direct them to submit
a 135-day PMA supplement or if the submission is too incomplete to make that
determination, the applicant will be directed to submit either a 135-day PMA
supplement or a new 30-day Notice (applicant's choice). This correspondence
must issue within 30 days of receipt of the 30-day Notice.
If no action occurs within 30 days of FDA receipt of the 30-day Notice as required
by section 515(d)(6)(A)(i) of the Federal Food, Drug, and Cosmetic Act (the
act), the applicant may proceed with the change without receiving approval from
FDA.
A flow chart is attached which shows the decision making process for action
on a 30-day Notice.
Joint Review by OC and ODE
Review of 30-day Notices and 135-day PMA supplements will be performed jointly
between the Office of Compliance (OC) and the Office of Device Evaluation (ODE).
OC will have the lead in the review of the submission, maintenance of the
administrative record and construction of any written correspondence. Each
review division within OC and ODE will have a designated point-of-contact who
is responsible for the coordination/evaluation of the 30-day Notice process.
The PMA Staff will maintain the list of points-of-contact. Given the short review
time frames and the joint office review, adequate communication (e-mail, fax,
phone, etc.) between the Offices must take place regarding these submissions.
The designated OC point-of-contact will be responsible for assuring identification
of issues related to the Quality System regulation. The ODE designated point-of-contact
will be responsible for assuring identification of issues related to safety
and effectiveness due to the proposed manufacturing change. Within 5 days following
receipt of the 30-day Notice, the ODE and OC designated points-of-contact will
confer to determine if the manufacturing change qualifies for a 30-day Notice.
Within 10 days of receipt, the points-of-contact should consider whether the
supplement can be completed as a 30-day Notice or the Notice is not adequate
and a 135-day PMA supplement is needed to implement the change. A meeting of
the points-of-contact should be considered to review the submission if it will
facilitate the process. The ODE designated point-of-contact will communicate
the review(s) and any deficiencies electronically (via disk, "L drive"
or E-Mail) to the OC point-of-contact who is coordinating the review process
for the 30-day Notice. Questions raised by the ODE point-of-contact regarding
the submission will follow the format of a deficiency letter for incorporation
into written correspondence to the PMA holder. The deficiency letter will contain
the integrated deficiencies of both offices. If any changes are necessary to
an ODE proposed deficiency (including not incorporating the proposed deficiency
into the letter), the ODE designated lead will be notified. The OC draft of
the proposed correspondence will be shared with the ODE point-of-contact for
final comment. The letter will be forwarded to ODE, PMA Staff for signature
by day 25. The letter will be faxed by the PMA Staff to the PMA holder.
Should there be scientific disagreement between OC and ODE, appropriate dispute
resolution procedures should be followed. For example see ODE Guidance Memorandum
#G93-1 "Documentation and Resolution of Differences of Opinion on Product
Evaluations."
Submission of a 30-Day Notice
To facilitate the review of a 30-day Notice, applicants are requested to clearly
identify in their cover letter that the submission is a 30-DAY NOTICE. Failure
to properly identify the submission will cause it to be regarded by the agency
as a supplemental PMA and will not allow the submitter to take advantage of
the 30-day Notice provision. Rather, the submission will be placed automatically
in the 180-day review queue for PMA supplements.
Applicants are requested to submit three identical copies simultaneously. To
facilitate joint review by OC and ODE, one copy should be sent to:
Food and Drug Administration
Office of Compliance
Field Programs Branch (HFZ-306)
ATTN: 30-day Notice
2098 Gaither Road
Rockville, Maryland 20850
The remaining two copies (the official copies) should be sent to:
Food and Drug Administration
Office of Device Evaluation
Document Mail Center (HFZ-401)
ATTN: 30-day Notice
9200 Corporate Blvd.
Rockville, Maryland 20850
PMA Letters and Database Tracking Considerations
Several new boilerplates have been created to facilitate the 30-day Notice/135-day supplement process.
The PMA database will be modified to enable tracking and reporting for the
30-day Notices and 135-day PMA supplements.
Effective Date
This guidance is effective February 19, 1998.
Attachment
Guidance Pertaining to the FDA Modernization Act
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