Guidance Pending To Help Clinical Labs Comply With FDA Manufacturing Regs
Full article reprinted from "The Gray Sheet" - May 04, 2009
Find out how FDA is developing guidance for clinical laboratories on how to comply with the device manufacturing quality system regulation.
Full article reprinted from "The Gray Sheet" - May 04, 2009
FDA is developing guidance for clinical laboratories on how to comply with the device manufacturing quality system regulation.
The effort involves CDRH's Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), which is working with visiting fellow and former device industry engineer Katherine Serrano to recommend a least burdensome approach for clinical labs to comply with the regulation.
The guideline writing comes as the agency is weighing whether to expand its oversight of laboratory-made assays.
Currently, FDA regulates commercially marketed diagnostic test kits, while CMS oversees laboratories under the 1988 Clinical Laboratory Improvement Amendments (CLIA).
Under CLIA, certain labs that earn the designation of "high complexity" can construct their own assays for diagnostic or prognostic use on patient samples sent to the lab by health care practitioners.
FDA has not historically regulated these types of lab services, meaning the tests do not need premarket approval nor do they need to comply with FDA post-market requirements, such as the quality system regulation. Instead, the labs need to comply with CLIA quality standards and are subject to periodic inspections from CMS contractors.
FDA has suggested an interest in regulating at least some lab-developed tests and believes it has authority to do so. Test kit makers, some members of Congress and public health experts have advocated for expanded federal regulation of lab-developed tests developed in clinical labs (1"The Gray Sheet" April 6, 2009, p. 23).
But lab stakeholders and diagnostics firms that develop tests through in-house, CLIA-certified laboratories worry about potentially redundant requirements (2"The Gray Sheet" Feb. 25, 2008, p. 14).
"Right now, for lab-developed tests, we apply enforcement discretion," acting OIVD director Don St. Pierre affirmed in an April 17 interview. "We're being asked whether that's the right thing to do."
St. Pierre could not predict whether QSR will be required for laboratories anytime soon, but he noted that CLIA and QSR regulations already appear to have a lot in common. "The language is different, but there are a lot of principles that are similar," he said.
Guidance Project Doesn't Assure Lab QSR Mandate
Visiting fellow Serrano, a biomedical engineer and former regulatory affairs specialist with Boston Scientific, began working with OIVD on the guidance document last fall as part of the FDA commissioner's fellowship program.
Serrano was teamed with FDA staffers Elizabeth Mansfield and Tonya Wilbon, who conceived of the CLIA/QSR guidance development project.
Sign up for your 30-day, risk-free trial of "The Gray Sheet" today.
"The Gray Sheet" gives you 51 issues per year filled with useful articles that will help you meet your business and regulatory objectives.
