# Presentation: 782450

## Premarket Approval Applications 

- Thinh Nguyen
- Director, Premarket Approval Section
- Office of Device Evaluation

## Overview	

- Class III
- Safety and Effectiveness
- Valid Scientific Evidence
- Contents Requirement
- Review Processes
- Criteria for Expedite Review
- User Fee

## Devices Which Need a PMA

- Class III:
- General Controls/Special Controls/Performance Standards Are Not Sufficient
- Supports or Sustains Human Life
- Substantial Importance in Preventing Impairment of Human Health
- Potential Unreasonable Risk of Illness or Injury

## Safety and Effectiveness	(21 CFR 860.7)

- Considerations
- Persons for Whose Use the Device is Intended
- Conditions of Use for the Device
- Possible Benefit to Health vs. Probable Injury or Illness from Use
- Reliability of the Device
- Reliance on Valid Scientific Evidence Only

## Valid Scientific Evidence	(21 CFR 860.7)

- Well-Controlled Investigations
- Partially Controlled Studies
- Studies and Objective Trials without Matched Controls
- Well-Documented Case Histories by Qualified Experts
- Reports of Significant Human Experience with a Marketed Device

## Valid Scientific Evidence Is Not:

- Isolated Case Reports
- Random Experience
- Unsubstantiated Opinions
- Reports Lacking Sufficient Details to Permit Scientific Evaluation

## Contents of Application (21 CFR 814.20)

- Applicant's Name and Address
- Signature of U.S. Representative
- Table of Contents
- Summary of Safety and Effectiveness Data
- Device Description and Manufacturing Section
- Voluntary Performance Standards
- Non-clinical and Clinical Data

## Contents of Application (Continued)

- Justification for Sole Investigator
- Bibliography and Other Relevant Information
- Samples of Device (if requested by FDA)
- Proposed Draft Labeling
- Environmental Assessment or Claim of Categorical Exclusion
- Other Information Requested by FDA or Panel

## Acceptance of Foreign Clinical Data

- Greater Protection: Declaration of Helsinki or Laws/Regulations of that Country
- Applicable to U.S. Population/Medical Practice
- Clinical Investigators of recognized Competence
- Valid Scientific Evidence (21 CFR 860.7)

## Premarket Approval Applications

- Original
- Supplement
- Amendment
- Report (Annual, Postapproval, Adverse)
- Masterfile

## PMA Documentation Processing

- 6 copies received:
- Copy 1 		IMAGE
- Copy 2		Review Division
- Copy 3		Shelf
- Copy 4		OC (GMP/BIMO)
- Copy 5		OSB (Statistics)
- Copy 6 		OCER (Patient Labeling)

## PMA Review Phases and Associated Letters

- Filing Review            	Filing/Not Filing
- Substantive Review  Major/Minor
- Status			    90 day letter/						100 day meeting
**Panel Meeting          ******** Panel Status**
**Decision                   ******** Approvable ****	****	****	****	****	****        Not Approvable****	****	****	****	****	****Approval****	****	****	****	****	****    ****	****        Denial**

## 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 The Patients

## Expedited - Procedures

- Receive priority review before other pending applications
- If multiple PMA meets expedited qualification, First In First Review

## Expedited - Procedures

- When one is approved:
- Remaining PMA lose expedited status
- Retain place in the review queue for the current cycle
- Subjected to standard FIFR procedures applicable to non-expedited submissions

## FY 06 User Fee

- Original PMA & PT Supplement –
- $259,600 ($98,648)
- Other PMA Supplements –
- $55,841 - $18,691 ($21,209 - $7,103)
- Small Business - $100 million in gross receipts or sales

## FY 06 User Fee

- _First_ PMA from firms with gross receipts or sales ≤ $30 million – Fee is waived
- Any application for a device intended solely for _pediatric_ use.

## How to Get Further Information

- World Wide Web
- http://www.fda.gov/cdrh/index.html
- PMA Staff
- Lisa Fisher/Pat Beverly/Marsha Melvin/Wanda Sawyer Major
- 301-594-2186