# Presentation: 161835

## Postmarket Surveillance: Medical Devices

- Susan Gardner, PhD
- Director, Office of Surveillance and Biometrics, CDRH
- FDLI Annual Meeting 4/08/05

## Office of Surveillance and Biometrics: Basic Functions

- Premarket review
- Statisticians
- Epidemiologists
- Signal detection via monitoring tools including MDR, MedSun
- Risk characterization (analysis)
- Coordination of nonregulatory response
- Interpretation of MDR regulation

## Drug-coated stents may face additional FDA scrutiny

**Drug-coated stents may face additional FDA scrutiny**

**FDA Advises Physicians of Adverse Events Associated with Cordis Cypher Coronary Stents**

## Pre-Postmarket Balance

- Use premarket data to make initial decisions about safety and effectiveness and gain understanding of device benefits and risks
- Use postmarket data to improve our understanding of the risk benefit profile; disseminate timely safety information or take regulatory action as appropriate

## Need for Postmarket Studies and Surveillance

- Limited size of premarket studies cannot detect or characterize events that occur at a low rate
- Need for long term follow-up (issues of durability/biocompatibility etc.)
- Use error
- Use of device in community practice or home care
- Concerns for selected patient groups
- Device/device or device/drug interactions
- Device failure
- Off label use

## Condition of Approval StudiesImmediate Postapproval Concerns

- Postapproval requirements can include
- “continuing evaluation and periodic reporting on the safety, effectiveness, and reliability of the device for its intended use.” 21 CFR 814.82 (a) (2).

## Indications for CoA Studies

- Need to refine risk estimates or better characterize safety issues, particularly uncommon and serious
- Need to study specific population subgroups
- Need to study long term effects
- Need to study use of device under conditions of general use

## CoA Quality Study: 2002-3

- 1998 through 2000: 127 PMAs approved with 45 CoA orders.
- CDRH had limited procedures for tracking progress or results
- Turnover of lead reviewers resulted in lack of follow-up
- No results received for 22%
- Two studies had not been started at all

## Strategy for Change

- Transfer CoA tracking and follow-up to OSB
- Develop and institute automated tracking system
- Acknowledge the receipt of study reports
- Follow-up when reports are not received

## Strategy for Change

- Add epidemiologist to PMA review team
- Tasked with the development of a postmarket monitoring plan
- Lead design of postmarket study development
- Lead the development of well formulated postmarket questions
- Lead in evaluation of study progress and results
- Will continue to work with PMA team

## Strategy for Change

- Develop guidance for industry and FDA to provide clear guidelines for content, format and due dates
- Periodically report the results of CoA  to Advisory Panels
- CDRH may post periodic status reports of CoA on Agency website

## Least burdensome Approach

- Least burdensome principles apply
- Acknowledged in FDA guidance
- “integrated in premarket..., as well as postmarket...as they relate to premarket...
- The “way” to Least burdensome is to discuss pre/postmarket balance as early as possible in the approval process.

## Elements of Protocols for Analytic Studies

- Study objective – reason for doing the study
- Define study group
- Outcomes of interest – safety issues
- Study design and procedures
- Study size
- Analysis plan
- Reporting requirements

## Elements of Protocols for Analytic Studies

- Our goal is to have these elements of the study protocol agreed upon before product approval.

## Adverse Event Reporting

- Medical Device Reporting (MDR)
- Approximate 130k reports/year
- Half are Summary Reports
- After initial triage, individual reports are monitored by analysts
- Look for rare, unexpected events, increase in events, seriousness of event, population affected, preventability
- Summary reports are monitored for change in trends
- Primarily manufacturer reports (90%)

## MDR Reports: 1998-2004

## Medical Device Safety Network (MedSun)

- 300 hospitals and other facilities trained to recognize and report device related adverse events; goal to reduce barriers to reporting
- Reports include “close calls”; emphasis on prevention
- Provides CDRH with connection to device users
- Reports and actions tend to focus on user issues, “everyday safety issues”
- Provides laboratory for quick surveys and other research projects

## Postmarket Surveillance: Section 522

- Allows CDRH to order postmarket surveillance studies for:
- Class ll or Class lll products
- Intended to be implanted for more than one year, or
- Life sustaining/life supporting and used outside user facility, or
- Failure would likely cause serious health consequences

## Postmarket Surveillance: Section 522

- CDRH poses public health question to industry
- Industry develops plan to address question
- Wide variety of study methods acceptable
- Generally limited to three year studies

## Other Surveillance Tools

- Observational Studies – de novo or existing cohorts
- Medical care claims data
- Registries – real world use
- International vigilance
- Rapid Response surveys

## Future Directions

- Goal: To improve our postmarket toolkit to allow us to make reasonable science-based decisions in evaluating the benefits and risks of medical devices