# Presentation: 265573

## David W. Feigal, M.D., M.P.H.
Director
Center for Devices and Radiological Health, FDA

- David W. Feigal, M.D., M.P.H.
- Director
- Center for Devices and Radiological Health, FDA

- RAPS Annual Meeting, October 2000

**CDRH Executive Briefing**

## Overview

**Overview**

- Organizational Update
- Budget and Performance
- International Device Regulation
- Global Harmonization Task Force
- International Standards
- Mutual Recognition Agreements
- Inspectional Resources
- Least Burdensome

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-    Inspections
- Hot Topics

## Center for Devices and Radiological Health 

**Center for Devices and Radiological Health**** **

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-    Inspections
- Hot Topics

## Total Medical and Radiological Devices Budget History in Constant 1999 Dollars ($000)

**Total Medical and Radiological Devices ****Budget History in Constant 1999 Dollars ($000)**

- Fiscal Years

- MQSA

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-    Inspections
- Hot Topics

## Pre-market Notification (510k) History

**Pre-market Notification (510k) History**

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-    Inspections
- Hot Topics

## CDRH FTE HistoryFiscal Years 1976-1999

**CDRH FTE History****Fiscal Years 1976-1999**

**Medical Devices**

**Radiological Health**

**Mammography Act**

**Fiscal Year**

- Med. Dev. Amend

- Merger of BRH &BMD

- SMDA

- MQSA

- FDAMA

## Performance:  PMA and PMA Supplement Total Review Times

**Performance:  PMA and PMA ****Supplement Total Review Times**

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-    Inspections
- Hot Topics

## Performance:  510(k)s - Alternatives

| Type of 510(k) | Reviews
Completed
12 months
FY99 | Average Total
Time (days) | Reviews
Completed
1st 9 months FY00 | Average Total
Time (days) |
| --- | --- | --- | --- | --- |
| Abbreviated | 75 | 99 | 75 | 60 |
| Special | 361 | 29 | 389 | 33 |
| Traditional | 4155 | 108 | 2637 | 115 |

## 3rd Party Reviews: Who is using it ?

- 19 Ultrasound  6 Diagnostic X-Ray  1 Emission CT

-   6 Drug of Abuse Tests  1 Epstein Barr Test

- GeneratorsFiberoptic LightsViewing Monitors

**Fiscal Year 1999:  52 3****rd**** Party Approvals**

## International Device Development

**International Device Development**

- The Scene
- U.S. Marketplace: 40% of approved device firms manufacture abroad
- U.S. Device Manufacturers have a positive trade balance
- Device Development
- Studies conducted world-wide
- Post Marketing Vigilance is a world-wide network
- Application formats are becoming harmonized
- Inspectional Methods are converging

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## International Forces

**International Forces**

- Business Forces
- Market Factors/ Reimbursement
- Intellectual Property
- Manufacturing Factors
- Import / Export Laws
- Regulatory Factors

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## International Forces

**International Forces**

- Complex Regulation
- 	for example in the United States:
- Device Authority:
- FDA, FTC
- Hospital and Clinical Laboratory
- FDA, HCFA, CLIA, MQSA, JCAHCO
- Trade Authorities
- FTC, WTO
- Other Authorities
- FCC 	 (wireless, telemetry)
- NRC (Nuclear radiation)

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## International Device Regulation

**Standards Conformance**

**Global Harmonization Task Force**

**Mutual Recognition Agreements**

**FORCES:**

**Quality****Systems**

**Lack of****Harmonization**

## Global Harmonization	Task Force

**Global Harmonization****	****Task Force**

- Next Meets:  October 11-16, 2001  Barcelona, Spain
- Four study groups:
- Regulatory Requirements / Premarket Review
- Device Vigilance / Post-Market Surveillance
- Quality System Requirements and Guidance
- Auditing
- www.ghtf.org

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## Global Harmonization	Task Force

**Global Harmonization****	****Task Force**

-    Progress continues...
- 12 documents approved, from four study groups
- Formal operating principles being developed
- MOU between GHTF and ISO/TC210 Committee on quality management
- Approved by ISO/TC210, awaiting approval by GHTF

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## Global Harmonization	Task Force

**Global Harmonization****	****Task Force**

-  **Approved Documents**
- Study Group 1
- Essential Principles of Safety & Performance of Medical Devices
- Labeling for Medical Devices
- Role of Standards in the Assessment of Medical Devices

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## Global Harmonization	Task Force

**Global Harmonization****	****Task Force**

-  **Approved Documents**
- Study Group 2
- Comparison of the Device Adverse Reporting Systems in USA, Europe, Canada, Australia & Japan
- Minimum Data Set for Manufacturer Reports to Competent Authorities
- Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices
- Global Medical Devices Vigilance Report
- Charge & Mission Statement
- Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## Global Harmonization	Task Force

**Global Harmonization****	****Task Force**

-  **Approved Documents**
- Study Group 3
- Guidance on Quality Systems for the Design & Manufacturing of Medical Devices
- Design Control Guidance for Medical Device Manufacturers
- Process Validation Guidance for Medical Device Manufacturers

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## Global Harmonization	Task Force

**Global Harmonization****	****Task Force**

-  **Approved Documents**
- Study Group 4
- Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements
- Audit Language Requirements
- Training Requirements for Auditors

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## Standards

**Standards**

- Role in US Device Regulation
- Quality Standards
- Cross-product performance standards
- Product specific standards
- Can replace portions of 510(k) applications
- E.g.,  A mechanical wheel chair 510(k) application can consist of declaration of conformance to 12 standards.
- Can facilitate 3rd party review

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    MRA
-  Inspections
- Hot Topics

## Using Standards to Support   SE Decisions in 510(k)s

**Using Standards to Support   ****SE Decisions in 510(k)s**

- Three alternatives:
- FDA recognized standard with a declaration
- Mfr. has data now
- FDA-recognized standard without declaration
- Mfr. does not have supporting data at time of submission but will before marketing
- Non-recognized standard
- Less assurance that standard will be acceptable
- FDA may need to request additional information

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## Problem Solving with Standards

**Problem Solving with Standards**

- Oxygen Regulators
- Problem:  Aluminum oxygen regulators are more susceptible to burning than brass, particularly with  rough handling in an EMS setting.
- Solution: Go back to Brass???  (Design Standard)
- Solution: Develop Ignition Standard and if a regulator can pass the standard it doesn’t matter what it is made of.  (Performance Standard)

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## Problem Solving with Standards

**Problem Solving with Standards**

- Medical Telemetry
- Problem:  When digital television started coming on line in Texas it blocked out the signals from medical telemetry monitoring devices
- Solution: Standardize the frequencies to be used for EMF and get the FCC to set aside for medical telemetry.

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## International Standards and FDA

**International Standards and FDA**

- ISO 9001  (2000)
- Where does it overlap with QSIT ?
- What can we learn from the ISO  	conformance inspections ?
- Harmonization and Standards
- CDRH Participation in Standards Organizations
- Global Harmonization Task Force

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## Mutual Recognition Agreements

**Mutual Recognition Agreements**

- MRAs do not harmonize requirements, standards or even tests.
- The goal of MRAs is to allow conformity assessment bodies (CABs) in various regions to do testing and certification that will be recognized in other regions as well as in their own.
- It is expected to lead to the reduction of requirements for multiple accreditations and certifications and the reduction of related costs.

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## MRA: Scope

**MRA: Scope**

- Inspections/Audits
- All devices regulated by both parties
- Product reviews/evaluations
- For EU CABs, 97 devices covered by FDAMA Third Party Program [510(k)]
- For US CABs, all devices regulated by both parties
- Vigilance Reports
- All devices regulated by both parties

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## MRA: Where are we?

**MRA: Where are we?**

- Both sides evaluated and nominated potential CABs
- We are starting to receive information on EU CABs to evaluate, especially for conflict of interest and qualifications
- Before sending US CAB information to the EC we are awaiting assurance that information will be held confidential

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## MRA: Where are we?

**MRA: Where are we?**

- Training EU CABs
- Classroom training on 510(k) reviews, Quality System Regulation and  FDA law, regulations, and procedures completed in 1999
- Practical experience (joint inspections) - 18 conducted by FDA investigators from October 1999 to June 2000

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## 1999 Device Inspections

**1999 Device Inspections**

**State**
**MQSA**
**Inspections**

**FDA**
**Total**

**FDA**
**MQSA**

**GMP**

**BIMO**

**Pre Approval**

**Other**

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## CDRH Establishment Inspections

**CDRH Establishment Inspections**

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## Device Inspections: US and ForeignClass II and III with relabelers

**Device Inspections: US and Foreign**Class II and III with relabelers

- Estimated

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## Device Inspections: US and ForeignClass II and III with relabelers

**Device Inspections: US and Foreign**Class II and III with relabelers

- Statutory
- Requirement

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## Inspections: How to get more from decreasing $$$?	

**Inspections: How to get more from decreasing $$$?****	**

- Changes are allowing Field to make best use of its time and resources in device inspections:
- “Grassroots” changes
- Reengineering changes
- QSIT :  Quality System Inspection Technique
- HAACP:  Hazard Analysis and  Critical        Control Points
- Conformance to Standards ?

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## Inspections:“Grassroots” Changes

**Inspections:****“Grassroots” Changes**

- Pre-announced inspections
- Annotation of 483’s
- Company corrections
- Post-inspection letters to all
- 			*vs.* only Warning Letters
- Warning Letters
- 15 days to respond to 483’s
- Untitled letter if response satisfactory

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## QSIT:Quality System Inspection Technique

**QSIT:****Quality System Inspection Technique**

- Paradigm shift:  looking at systems rather than at product problems
- Inspection focuses on four subsystems
- Management controls
- Design controls
- Corrective and preventive action (CAPA)
- Production and process controls

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## HACCP: Hazard Analysis & Critical Control Points

**HACCP: ****Hazard Analysis & Critical Control Points**

- Goal: to prevent production problems
- Inspectional approach: mfrs. determine their critical control points, control them
- Investigators and auditors focus on critical control points

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics

## Hot Topics

**Hot Topics**

- ReUse of Single Use Devices
- Implant Safety and Effectiveness
- Breast Implants
- Joint Implants
- Cell Phone Safety
- Least Burdensome
- Dispute Resolution

**CDRH Executive****Briefing**
**Organizational Update**
**Budget & ****Performance**
- International Device Regulation
-    GHTF
-    Standards
-    MRA
-  Inspections
- Hot Topics