Inspection of Medical Device Manufacturers

Posted on January 26, 2012. Filed under: Uncategorized |

PROGRAM 7382.845

SUBJECT: INSPECTION OF MEDICAL DEVICE MANUFACTURERS
IMPLEMENTATION DATE: February 02, 2011 (Previous editions obsolete.)
COMPLETION DATE: February 2, 2015
DATA REPORTING
PRODUCT CODES: 73-91
PRODUCT/ASSIGNMENT CODES:
82845A; 42845A — All Level 1 (Abbreviated) Inspections
82845B; 42845B — All Level 2 (Comprehensive) Inspections
82845C; 42845C — All Level 3 (Compliance Follow-up) Inspections
82845G — All For Cause Inspections
82845P — Joint FDA/Accredited Person Inspections
82845S — Report Time spent on Assessment of Firm’s Sterilization processes
81010 — Report Time spent on MDR Follow-up
81011 — Report Time spent on Assessment of Firm’s MDR Practices
81845T — Report Time spent on Assessment of Firm’s Tracking Practices
81845R — Report Time spent on Assessment of Firm’s Corrections and Removals Practices
82A800 — Independent Accredited Person Inspections

Table of Contents

  1. The Quality System (QS) Regulation
  2. The MDR Regulation
  3. The Medical Device Tracking Regulation
  4. The Corrections and Removals Regulation
  5. The Registration and Listing Regulation
  1. Objectives
  2. Program Management Instructions
  1. Operations
    1. Inspectional Strategy
      1. QS inspections
      2. Level 1 inspections
      3. Level 2 inspections
      4. Level 3 inspections
      5. For Cause Inspections
      6. Foreign Inspections
    2. Inspectional Instructions
    3. Special Instructions Concerning Design Controls
    4. Special Instructions for Sterilization Processes
    5. Inspection of Radiation Emitting Devices
    6. Sample Collection
  2. Additional Considerations
    1. Registration and Listing
    2. Imports
    3. Exports
    4. Electronic Records and Electronic Signatures
  3. Remarketed Devices
  4. Reporting
  1. Analyzing Laboratories
  2. Analyses to be Conducted
  3. Methodology
  1. Quality System/GMP Regulatory/Administrative Follow-up
    1. Compliance Decision
    2. Contract Sterilizers, Contract Device Manufacturers and Finished Device Manufacturers – Deciding Responsibility When Taking Regulatory Action
    3. Violative Devices Sold to Government Agencies
    4. Administrative and Judicial Actions
    5. Facilitating Review of Regulatory Recommendations
  2. MDR Regulatory/Administrative Follow-up
  3. Tracking Regulatory/Administrative Follow-up
  4. Corrections and Removals Regulatory/Administrative Follow-up
  5. Registration and Listing Regulatory/Administrative Follow-up
  6. Radiation Emitting Device Regulatory/Administrative Follow-up
  7. Exports Regulatory/Administrative Follow-up
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