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U.S. Department of Health and Human Services

Medical Devices

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Mammography Facility Inspections

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Date of Issuance: (draft dated 07/23/2009)

PROGRAM 7385.014

SUBJECT: MAMMOGRAPHY FACILITY INSPECTIONS

IMPLEMENTATION DATE:

COMPLETION DATE:

DATA REPORTING

PRODUCT CODES:
90I_ZH - screen/film mammography system
90M_UE - full-field digital mammography system
Establishment Type E

PROGRAM ASSIGNMENT CODES:
85014 -- Routine Inspections
85014A -- Quality Assurance Audits
85014C -- Compliance (Coord./Tech. Asst.)
85014F -- Follow-up Inspections
85S001 -- State Inspections

Table of Contents

Cover Page

Part I: Background

Part II: Implementation

  1. Objective
  2. Program Management Instruction

Part III: Inspections

  1. Facility Inspections
  2. Compliance Follow-Up for Inspections
  3. Inspection Quality Assurance Audits and Mentoring
  4. Follow-Up and Compliance Inspections
  5. Uncertified Facilities
  6. Possible Criminal Activity at a Facility
  7. Mammography Equipment Problems (Non-MQSA)
  8. Complaints about Patient Access to Mammograms

Part IV: Analytical (No laboratory testing will be done under this program.)

Part V: Regulatory / Administrative Strategy

  1. Regulatory Philosophy and Strategy
  2. Case Guidance

Part VI: References, Attachments and Program Contacts

  1. References
  2. Attachments
  3. Program Contacts

Part VII: Center Responsibilities

  1. CDRH / OCER / DMQRP
  2. Program Review

Attachments

Attachment A: List of CDRH personnel (inspection, compliance, audits, and workplans)

Attachment B: List of CDRH personnel (computer support and testing equipment)

Attachment C: List of MQSA Auditors

Attachment D: Form FDA 2766 Claim for Damage to an Electronic Product

Attachment E: Observation Statements for MQSA Inspections

Attachment F: Guidance for Evaluating a Facility Response

Attachment G: Guidance for an Additional Mammography Review (AMR)

Attachment H: Flowchart - Follow-Up for MQSA Inspections

Attachment I: Warning Letter

Attachment J: Adequate Response Letter to Facility

Attachment K: Example of MQSA Facility Inspection Report

Attachment L: Important Information about Your MQSA Inspection document

Attachment M: Sample MQSA Inspection Confirmation (5 days prior to inspection)

Attachment N: MPRIS Web

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