Compliance program guidance manual for inspection of medical device manufacturers

 · The Food and Drug Administration (FDA) is announcing the availability of a compliance program (CP) entitled “Inspection of Medical Device Manufacturers.” This CP is intended to help FDA components and industry comply with FDA's internal inspection and compliance processes concerning quality system/good manufacturing practice (QS/GMP) inspections of manufacturers of medical Estimated Reading Time: 4 mins. Compliance Program Guidance Manual: Inspection of Medical Devices__ Contact [Name, mail stop and phone number]: Wes Morgenstern, HFZ () _ Originating Org.:Office of Compliance, Div. Prog. Oper./ Field Programs Br. REVIEW COMMENT: Internal Agency Organizations signature date OCD L. Kahan 3/5/98 OCC M. Porter 4/13/ Guidance Documents (can be accessed from www.doorway.ru website under Medical devices CDRH Device Advice Quality Systems Manual: A Small Entity Compliance Guide on-line Compliance Policy Guides Quality System Inspection Techniques (QSIT) Compliance Program Guidance Manual • CP Inspection of Medical Device Manufacturers.

COMPLIANCE PROGRAM GUIDANCE MANUAL PART I BACKGROUND PROGRAM This compliance program provides guidance to FDA field and center staffs for the inspections and administrative/enforcement activities related to the Quality System (QS) regulation (21 CFR Part ), the Medical Device Reporting (MDR) regulation (21 CFR Part ), the Medical Device. compliance program guidance manual program. subject: inspection of medical device manufacturers. implementation date february 2, completion date february 2, ;. r Compliance Program Guidance Manual for Inspection of Medical Device Manufacturers (CP ). r Investigations Operations Manual (IOM).

Compliance Program Guidance Manual: CP located at website: "Inspection of Medical Device Manufacturers” located under "Quality Audits" at. Items 1 - 9 QSIT Guide to Inspections of Quality Systems. 4. Compliance Program Guidance Manual: Inspection of Medical. Device Manufacturers. While the RPM is intended mainly to provide guidance to FDA inspectors, investigators, and compliance officers, the document is likely to be useful to industry.