FY 2009 OSEL Regulatory Support Activities
Research conducted in the OSEL supports the regulatory activities of the Agency as follows:
- Strategically manage research with the aim of providing a scientifically sound basis for responding to current needs and anticipating future regulatory challenges; and
- Provide technical consults in support of the Center’s pre-market, post-market, and compliance activities.
Both activities are coordinated within OSEL in an effective manner so as to best meet Center’s regulatory science needs. Laboratory research is the cornerstone upon which the Office provides the regulatory support function. (The research is described in subsequent sections.) It is largely based on investigations related to the mechanistic understanding of device performance or test procedures, enabling the Center and device manufacturers to gain an improved understanding of issues related to safety and efficacy. In general, although the research is directed toward issues identified at the pre-market approval level, the reality is that the research has the largest impact on the post-market end of the Center’s business because most often the research is anticipatory in terms of potential issues of medical devices identified at the pre-market level.
The regulatory support function of the Office is provided through consults supporting both pre-market decisions and post-market actions using expertise developed in the laboratory. A consult is a request for expert advice or information of a specific nature, where it is perceived that expertise is more discipline-related than medical device-related. Consults provide information that contribute to sound regulatory decisions. Consults are often based on acknowledged scientific/engineering principles or on independent data generated in OSEL laboratories.
OSEL continues to actively engage in the regulatory activities of the Center by providing consults. In 2009 OSEL provided the following:
Number of consults to pre-market issues: 1348
Number of consults to post-market issues: 153
The information provided by a consult is used in some of the following ways:
- Evaluate a pre-market submission (IDE, HDE, PMA, 510(k));
- Support a compliance action (regulatory case support/development, Health Hazard Evaluation, Health Risk Assessments, etc.);
- Assist scientific collaboration;
- Respond to a consumer inquiry;
- Provide feedback on guidance documents;
- Provide revisions to one-pagers for the new device approval page; and support health hazard evaluation/health risk assessments or in device determinations/classifications.
For many post-market as well as pre-market regulatory issues, the consults/reviews and investigations conducted by OSEL independently assess the claims made by manufacturers or other parties concerning safety or effectiveness. In other cases, OSEL reviews may assess the adequacy of a design, a failure investigation, a production process, or a quality process employed by the manufacturer. These reviews and analyses rely on in-house expertise and are often augmented by expertise solicited from colleagues in academia, other government laboratories, or even other industry sectors. OSEL laboratory investigations may be undertaken in instances where the veracity of a performance claim needs to be independently verified by testing, or when the claimant lacks the resources to conduct the investigation.,
OSEL also provides analytical support to post-market regulatory activities in a variety of ways:
- Provide scientific and engineering reviews and analyses;
- Conduct laboratory investigations of product performance;
- Participate in inspections of medical device establishments;
- Conduct forensic reviews and investigations;
- Identify device safety and performance issues;
- Provide training to FDA and industry; and
- Contribute to Center-wide Matrix teams on issues identification as well as science-based analysis of post-market device performance.
Finally, developing standards and measurements methods is a significant activity of this office. OSEL continues to provide innovative solutions to public health problems by constructing generic techniques that lead to the creation of national and international standards that will enhance product safety and effectiveness. OSEL staff actively participate in developing standards at the national and international levels by performing research to establish standard procedures and by shouldering standards committees responsibilities to manage, develop, and support.