# Presentation: 242081

## Device Regulation in an International Milieu

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

*Paris, September 25, 2000*

## 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

## International Forces

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

## 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)

## International Device Regulation

**Standards Conformance**

**Global Harmonization Task Force**

**Mutual Recognition Agreements**

**FORCES:**

**Quality****Systems**

**Lack of****Harmonization**

## 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

## 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

## 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
- 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

## 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
- 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

## International 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.

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

- FDAMA intended to
- Encourage using FDA-recognized standards
- Provide a formal option but not limit past practices
- Declarations are legally binding & enforceable
- Cross-cutting standards used most often
- Least burdensome approach

## 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

## 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.

## 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

## 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

## 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

## 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**