lunes, 13 de junio de 2016

FDA Implements Administrative Changes for Modular Premarket Approval Applications (PMAs); Effective June 13, 2016

FDA Header

Dear Modular PMA Holder:
We are writing to inform you that effective June 13, 2016, FDA's Center for Devices and Radiological Heath (CDRH) has implemented several process changes involving Modular PMAs.  These changes are the latest in a series of process changes regarding premarket submissions (previous changes involved premarket notifications (510(k)s), investigational device exemptions (IDEs), humanitarian device exemptions (HDEs), and PMAs).  The process changes primarily address how incoming submissions are identified and numbered, and how CDRH will communicate decisions on incoming submissions.
This table identifies aspects of the Modular PMA and the associated process change:
Modular PMA aspectBefore June 13, 2016Starting June 13, 2016
PMA Shell:  module identificationapplicant specifies: 
(1) module number (e.g., M001) and 
(2) descriptive title (e.g., biocompatibility)
applicant specifies: 
(1) descriptive title (e.g., biocompatibility)
PMA Module:  numberingpre-assigned by sponsor with submission of PMA Shellassigned sequentially by FDA (i.e., M001, then M002, etc.) as Modules are submitted
Individual PMA Module:  
changes to accepted module
supplement to Moduleamendment to Module
Entire Modular PMA submission:  request to withdrawamendment to Modular PMA Shell (e.g., A001)withdrawal document to Modular PMA Shell (e.g., WD001)
Individual PMA module:  request to withdrawamendment to individual PMA Modulewithdrawal document to individual PMA Module

This table identifies the CDRH decisions that will now be communicated via an email only, instead of an email with a letter.  There is no change in processing of PMA Modules on Manufacturing:
Purpose of communicationCDRH Action before June 13, 2016CDRH Action starting June 13, 2016
PMA Shell:  acceptancesend 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:  acceptancesend 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:  withdrawalsend 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.

Frequently Asked Questions:

What will happen to module numbering if I have submitted a Modular PMA prior to June 13, 2016?
Existing modules will keep their module numbering.  Any new modules submitted on or after June 13, 2016, will be assigned a number sequentially, with the next number after the prior module of the highest number.  For example, if you previously submitted M002 and M004, the next module will be assigned M005.  As a result, the numbering for new modules will likely differ from what is listed in a PMA Shell accepted prior to June 13, 2016.

Will these changes affect the review clock of submissions currently under review?
No.  These changes will not impact the review clock for submissions currently under review.

Do I need to submit an amendment to my Modular PMA Shell to change the numbering of the modules?
No.  Each new module will be numbered sequentially as it is received.  When submitting new modules please identify the module accordingly to its descriptive title, e.g.," Preclinical Testing," "Biocompatibility Testing," etc.

If you have any questions about these changes, please contact the Division of Industry and Consumer Education (DICE) at or by phone at (800) 638-2041 or (301) 796-7100.

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