# Presentation: 736141

## MDUFMA Stakeholder MeetingDecember 3, 2003 

-      Modular & Expedited 			PMA Updates

**	****	****	****	**
**	****	****	****	****Thinh Nguyen**
**	****	****          ****Director, Premarket Approval Section**
**	****	****	****	****CDRH/ODE**

## Modular PMA 

- MDUFMA Amended Section 515(c) of the FFD&C Act to allow for modular review
- Guidance includes:
- User fee requirements
- Additional tools:  Flow charts, FAQ and Sample Shell

## Modular PMA User Fee & Review Clock

- Full fee is due upon submission of first module to start 90-day review clock
- 90-day review period for each module and amendment responding to a deficiency letter
- Unsolicited major amendment restarts the 90-day review period
- Upon receipt of final PMA module, PMA # will be assigned and 180-day review clock will start

## Modular PMA Guidance	

- Scope: original PMAs and PMRs
- Submit PMA modules in accordance with agreed upon shell
- FDA may refuse to accept a proposal for a PMA shell if the timing is inappropriate
- Only clinical module may be submitted as the final module

## Modular PMA Guidance

- PMA Modules
- Complete all testing for each module before submitting the module
- FDA will reject any incomplete module
- Final PMA Module
- Identify and address all outstanding deficiencies in final PMA module
- Filing review will be conducted

## Expedited PMA - Criteria

- Intended to treat or diagnose a life-threatening or irreversibly debilitating disease or conditions, AND met one of the following criteria:
- Breakthrough Technologies
- No Approved Alternatives Exist
- Offer Significant Advantages Over Existing Approved Alternatives
- Availability Is In The Best Interest of Patients

## Expedited PMA - Criteria

- Combination products:
- eligible for expedited review when CDRH or CBER has been designated as the lead center
- Requests from U.S Department of Defense or Department of Homeland Security:
- eligible for expedited review when the availability of the device is necessary for national security

## Expedited – MDUFMA Goals

- Apply when device meets criteria for expedited review _**AND**_:
- Applicant attends pre-PMA meeting
- Application must be substantively complete, as defined at the pre-PMA meeting
- Manufacturing information is complete and site is ready for inspection

## Expedited - Procedures

- Identify device that may meet expedited criteria early
- Applicant provides request in writing
- ODE Division reviews requests, documents decision and notifies applicant
- Receive priority review before other pending applications
- If multiple PMAs meet expedited qualification, First In First Review (FIFR)

## Expedited - Procedures

- When an expedited PMA is approved:
- Expedited status is removed from other devices that are under expedited review for same technology and/or indication for use
- Retain place in the review queue for the current cycle
- Subjected to standard FIFR procedures applicable to non-expedited submissions

## Additional Information

- World Wide Web:
- _[http://](http://www.fda.gov/cdrh/mdufma/index.html)__[www.fda.gov/cdrh/mdufma/index.html](http://www.fda.gov/cdrh/mdufma/index.html)_
- Contact the PMA Staff (301-594-2186)
- Thinh Nguyen
- Lisa Fisher
- Nicole Wolanski
- Wanda Sawyer-Major
- Laura Byrd
- Pat Beverly