CDRH QSIT Team Considers Third-Party Audit Option To Level 1 Inspections
This article was originally published in The Gray Sheet
Executive Summary
Firms with a good compliance history may be eligible to submit third-party auditing certifications in lieu of biennial FDA inspections, according to a proposal being drafted for consideration by the Center for Devices and Radiological Health's quality systems inspection technique (QSIT) reengineering team.
You may also be interested in...
FDA Committed To Third-Party Review, Henney Tells Senate HELP Committee
FDA Commissioner Jane Henney is "puzzled" about the low utilization rate within the device industry of the agency's "Accredited Persons" third-party premarket review program, she said at an Oct. 21 Senate Health, Education, Labor and Pensions Committee hearing.
FDA Considering Alternatives To Abbreviated Inspections As QSIT Gears Up
Quality systems inspections of device manufacturers between Oct. 1, 1999 and Jan. 1, 2000 will employ either traditional or Quality Systems Inspection Technique (QSIT) methods, depending on inspector training, FDA officials report.
Abbreviated FDA Inspections Outlined In Draft CPG For Auditing Program
Medical device facilities should receive a comprehensive quality system inspection every six years "as district resources permit" with "abbreviated" inspections in between, according to a draft FDA compliance program guidance (CPG) on auditing device manufacturers.