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  5. Medical Device Premarket Approval and Postmarket Inspections - Part VI: References, Attachments and Program Contacts
  1. Quality and Compliance (Medical Devices)

Medical Device Premarket Approval and Postmarket Inspections - Part VI: References, Attachments and Program Contacts

REFERENCES, ATTACHMENTS, AND PROGRAM CONTACTS

  1. Applicable References

    1. Guide to Inspections of Quality Systems, August 1999
    2. Code of Federal Regulations, Title 21, Part 803, Medical Device Reporting.
      Code of Federal Regulations, Title 21, Part 806, Reports of Corrections and Removals.
      Code of Federal Regulations, Title 21, Part 807, Establishment Registration and Device Listing.
      Code of Federal Regulations, Title 21, Part 820, Current Good Manufacturing Practices/Quality System Regulation.
      Code of Federal Regulations, Title 21, Part 821, Tracking Requirements.
      Code of Federal Regulations, Title 21, Part 860, Medical Devices Classification Procedures.
    3. Investigations Operations Manual (IOM) - Chapter 5, Subchapter 5.6, Devices
    4. Regulatory Procedures Manual
    5. Federal Food, Drug and Cosmetic Act, As Amended
      Section 513 [U.S.C.360c](a)(1)(C) Classification Class III, Premarket Approval
    6. Compliance Program Guidance Manual: Inspection of Medical Devices; (C.P. 7382.845), 2/2/2011.
    7. MDUFMA — Device user fees were first established in 2002 by the Medical Device User Fee Modernization Act(MDUFMA). User fees were renewed in 2007, with the Medical Device User Fee Amendments to the FDA Amendments Act (MDUFA II), in 2012 with the Medical Device User Fee Amendments to the FDA Safety and Innovation Act (MDUFA III), and in 2017 with the Medical Device User Fee Amendments to the FDA Reauthorization Act (MDUFA IV).  MDUFA IV will be in place from October 1, 2017 until September 30, 2022. More information on MDUFMA and User Fees is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalD eviceUserFeeandModernizationActMDUFMA/default.htm
    8. Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff, Issued March 3, 2003.
    9. Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices, Issued February 29, 2008.
    10. The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations. Issued January 8, 2008.
    11. Quality Management System — Medical Devices — Guidance on Corrective Action and Preventive Action and Related QMS Processes, Issued November 4, 2010disclaimer icon.
    12. Quality Management System — Medical Devices — Guidance on the Control of Products and Services Obtained from Suppliers, Issued December 11, 2008  disclaimer icon.
    13. Implementation of Risk Management Principles and Activities within a Quality Management System, Issued May 20, 2005disclaimer icon  .
    14. Quality Management Systems — Process Validation Guidance, Issued January  2004.

    Copies of CDRH QS publications and FDA guidance documents are available from the Division of Industry and Consumer Education (DICE), Telephone: 800-638-2041 or 301-796-7100 or Email at: dice@fda.hhs.gov. Many of these publications are also available in the CDRH Good Guidance Practices (GGP) Database.

    Sources to obtain copies free of charge:

    Internet (World Wide Web): FDA, CDRH, and ORA maintain web sites for easy access to information. The FDA home page is http://www.fda.gov; the CDRH home pages are http://www.fda.gov/MedicalDevices and http://www.fda.gov/Radiation-EmittingProducts; and the ORA home page is http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/default.htm.

    Good Guidance Practices (GGP) Database: This is a searchable database that contains all current CDRH guidance documents and provides links to the documents. (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfm)

    • Program Contacts

      1. ORA Contacts
        1. Questions regarding inspectional requirements and/or technical assistance:

          Division of Domestic Field Investigations
          Medical Device Group
          Telephone: (301) 796-0358

          Or

          Division of Foreign Field Investigations
          Medical Device Group
          Telephone: (301) 796-0357

      2. CDRH Contacts
        1. Questions regarding the interpretation of the PMA regulations and specific PMA inspection assignments should be directed to:

          PMA Preapproval Inspection Assignments:

          PMA Preapproval Coordinator
          Field Operations Branch
          Division of Risk Management Operations Office of Compliance
          Telephone: (301) 796-5815

          PMA Postmarket Inspection Assignments:

          PMA Postmarket Coordinator
          Field Operations Branch
          Division of Risk Management Operations Office of Compliance
          Telephone: (301) 796-5818

        2. Questions regarding the interpretation/applicability of the device Quality System regulation or information contained in the manufacturing section of the PMA should be directed to:

          Deputy Director for Regulatory Affairs
          Office of Compliance
          Telephone: (301) 796-5500
          Jan Welch
          Quality System/IVD Expert
          Telephone: (301) 796-5776
          Email: jan.welch@fda.hhs.gov

        3. Questions regarding the MDR Regulation Interpretation and Policy should be directed to:

          MDR Policy Branch
          Division of Postmarket Surveillance
          Office of Surveillance and Biometrics
          Email: rsmb@fda.hhs.gov
          Telephone: (301) 796-6670
          Fax: (301) 847-8135 (call or send email alert if sending a fax)

        4. Questions regarding the data retrieval of MDR reports should be directed to:

          Information and Analysis Branch
          Division of Postmarket Surveillance
          Office of Surveillance and Biometrics
          Email: MDR.Requests@cdrh.fda.gov

        5. Questions regarding medical device software, quality system software, or production/manufacturing equipment software should be directed to:

          John F. Murray
          Software Compliance Expert Office of Compliance
          Telephone: (301) 796-5543
          Email: john.murray@fda.hhs.gov

        6. Questions regarding sterilization should be directed to:

          Patrick Weixel
          Office of In Vitro Diagnostic Devices
          Telephone: (301) 796-5537
          Email: patrick.weixel@fda.hhs.gov

        7. Questions concerning in vitro diagnostic devices should be directed to:

          James Woods
          Deputy Director, Patient Safety and Product Quality
          Office of In Vitro Diagnostic Devices
          Telephone: (301) 796-6225
          Email: james.woods@fda.hhs.gov

        8. Questions concerning this compliance program should be directed to:

          Melissa Torres
          Office of Compliance
          Telephone: (301) 796-5576
          Email: melissa.torres@fda.hhs.gov

        9. Refer to the CDRH/OC and OIVD Organizational Charts in Attachments B and C respectively, to identify the unit within OC or OIVD that is responsible for the type of PMA device for which you have a question or need guidance. The organizational chart contains the contact numbers for the enforcement divisions and branches in OC and OIVD.

    • Attachments

      Attachment A: Notification of PMA Postmarket Inspection Form
      Attachment B: CDRH Office of Compliance Organizational Chart
      Attachment C: CDRH Office of In Vitro Diagnostic Devices Organizational Chart


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