CDRH Modular PMA Alert – Process Changes

30 Jun CDRH Modular PMA Alert – Process Changes

exclamationThe FDA’s Center for Device and Radiological Health (CDRH) has issued a memo to modular PMA Holders regarding the implementation of PMA process changes that went into effect on June 13, 2016.

The memo addresses how incoming Modular PMA submissions will be identified and numbered, and how CDRH will communicate decisions regarding these submissions. The changes will not impact the review clock for submissions currently under review.

Module Numbering and Identification

Existing modules will keep their module numbering. Any new modules submitted on or after June 13, 2016 will be numbered sequentially in the order they are received (i.e. M001, M002, M003, etc). For example, if you previously had submitted M002 and M004, the next module will be assigned the module number M005.  As a result, the numbering for new modules will likely differ from what is listed in your PMA Shell if it was accepted prior to June 13, 2016.

Applicants will not need to submit an amendment to their modular Shells in response to this new process. Instead, all future submissions should be identified based on the descriptive title of the module, and the FDA will assign the sequential number upon receipt.

In addition, modifications or changes made to existing modules should now be submitted as amendments instead of supplements.

Below is a table which summarizes the process changes being implemented by CDRH.

CDRH Process Changes

Modular PMA aspect Old Process New Process
PMA Shell

module identification

Applicant specifies:

·         module number (e.g., M001)

·         descriptive title (e.g., biocompatibility)

Applicant specifies:

·         descriptive title (e.g., biocompatibility)

PMA Module

numbering

Pre-assigned by sponsor with submission of PMA Shell Assigned sequentially by FDA (M001, followed by M002, etc.) as Modules are submitted
Individual PMA Module
changes to accepted module
Supplement to Module Amendment to Module
Entire Modular submission

request to withdraw

amendment to Modular PMA Shell (e.g., A001) withdrawal document to Modular PMA Shell (e.g., WD001)
Individual PMA module

request to withdraw

amendment to individual PMA Module withdrawal document to individual PMA Module

 

Communication of Decisions

Certain decisions made regarding acceptance and withdrawal will now be communicated by email only, as opposed to emails sent with letters of acceptance attached. The CDRH decisions that will now be communicated via an email only are listed below.

Please note, there will be no change in the processing for PMA Manufacturing Modules.

CDRH Communication Changes

Purpose of communication CDRH Action before June 13, 2016 CDRH Action starting June 13, 2016
PMA Shell Acceptance Send email with letter noting acceptance of shell and including accepted shell as attachment. Send email stating that CDRH has reviewed your proposed modular PMA shell and agrees with your proposed shell.  Email will include a copy of the accepted shell.
PMA Module Acceptance Send email with letter noting acceptance of module. Send email stating that CDRH has reviewed your proposed PMA module, and that module is accepted and is now considered closed.
Entire PMA Shell/Module Withdrawal Send email with letter noting acceptance of withdraw. Send email stating that CDRH has reviewed your request to withdraw a module or a modular PMA, and the submission is now considered withdrawn.

 

Significance

Modular PMA Holders should be sure to make note of these changes, because failure to do so could result in confusion when communicating with the FDA and/or the submission not meeting eCopy requirements.

Boston Biomedical Associates is an experienced CRO with proficiency in successful management of modular PMA submissions and communications with the FDA. We are able to help your organization to better understand applicable regulations and to submit quality marketing applications.

If you have questions about this guidance or need assistance please contact us by email at info@boston-biomedical.com or fill out our contact form.

Alyssa Woodcock
awoodcock@boston-biomedical.com

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