of the facility’s MQSA certificate (21 CFR 900.11(c)).  A facility that fails to

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Instructions for Completing the Medical Device Reporting Annual User Facility Report, Form FDA3419 | FDA Skip to

Advice: Comprehensive Regulatory Assistance Digital Health Center of Excellence Medical Device Development Tools (MDDT) Medical Device Safety Medical Devices

Advice: Comprehensive Regulatory Assistance Digital Health Center of Excellence Medical Device Development Tools (MDDT) Medical Device Safety Medical Devices

Mammography Facility Adverse Event and Action Report - June 30, 2022: Medical University of South Carolina Hollings Cancer

Mammography Facility Adverse Event and Action Report - September 13, 2021: Hoffman Medical Center, a/k/a

Advice: Comprehensive Regulatory Assistance Digital Health Center of Excellence Medical Device Development Tools (MDDT) Medical Device Safety Medical Devices

Delta Medical Center MQSA Reports and Safety Notifications Status of the Facility Missouri Delta Medical Center

of the malfunction of the device or other similar devices. See Medical Devices; Medical Device User

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and Safety Alerts Press Announcements Warning Letters Advisory Committees En Espa&#241ol Products Food Drugs Medical Devices Radiation-Emitting Products

Development Home Radiation-Emitting Products Radiation Safety Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging Facility Guidelines and

a Qualified Facility Attestation (QFA) status? Yes. Your facility must have a valid food facility registration to submit

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Submitting Qualified Facility Attestation Qualified Facility Attestation Instructions for Submitting Qualified Facility Attestation Qualified Facility Attestation Resources Docket Number

FDA Extends Flexibility for Unique Facility Identifier Requirement for Food Facility Registration through December 2022 | FDA Skip

Products and Medical Procedures General Hospital Devices and Supplies Ethylene Oxide Sterilization Facility Updates General Hospital Devices

If your facility is selected to participate in the audit, your facility may be notified to

Fee Programs Human Drug Compounding Outsourcing Facility Fees FDA User Fee Programs Human Drug Compounding Outsourcing Facility Fees Human Drug Compounding

the Qualified Facility Attestation Module. Please note that facilities must have a valid food facility registration to submit

Instructions Update Food Facility Registration Retrieve Food Facility Registration PIN Food Facility Biennial Registration Renewal Food Facility Registration Additional Capabilities Food

Webinar on Food Facility Registration (FFR), Biennial Renewal, and Unique Facility Identifiers (UFI) - 08/11/2022 | FDA Skip to

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this section CDRH International Affairs International Medical Device Regulators Forum (IMDRF) Asia-Pacific Economic Cooperation (APEC) Medical Device Single Audit Program

Outsourcing Facility Fees Home For Industry FDA User Fee Programs Human Drug Compounding Outsourcing Facility Fees Outsourcing Facility User

For Industry FDA User Fee Programs Mammography Facility Fees (MQSA) FDA User Fee Programs Mammography Facility Fees (MQSA) Share Post

Food Facility Registration Statistics | FDA Skip to main content Skip to FDA Search Skip

Webinar on Food Facility Registration (FFR), Biennial Renewal, and Unique Facility Identifiers (UFI) - 08/11/2022 | FDA Skip to

Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier

Action Report - December 16, 2016: DeQueen General Hospital Inc. dba DeQueen Medical Center (PDF - 158KB) Mammography Facility Adverse Event and

Inc. Mammography Facility Adverse Event and Action Report - July 26, 2018: Palm Beach Broward Medical Imaging Center Mammography Facility

2019 Mammography Facility Adverse Event and Action Reports | FDA Skip to main content Skip to

Radiology Consultants Mammography Facility Adverse Event and Action Report – December 8, 2022: Missouri Delta Medical Center Mammography Facility Adverse

Report - March 13, 2020: The Breast Institute at JFK Medical Center North Campus Mammography Facility Adverse Event and

Instructions Update Food Facility Registration Retrieve Food Facility Registration PIN Food Facility Biennial Registration Renewal Food Facility Registration Additional Capabilities Food

Instructions Update Food Facility Registration Retrieve Food Facility Registration PIN Food Facility Biennial Registration Renewal Food Facility Registration Additional Capabilities Food

2021 Mammography Facility Adverse Event and Action Reports | FDA Skip to main content Skip to

Instructions Update Food Facility Registration Retrieve Food Facility Registration PIN Food Facility Biennial Registration Renewal Food Facility Registration Additional Capabilities Food

Instructions Update Food Facility Registration Retrieve Food Facility Registration PIN Food Facility Biennial Registration Renewal Food Facility Registration Additional Capabilities Food

Instructions Update Food Facility Registration Retrieve Food Facility Registration PIN Food Facility Biennial Registration Renewal Food Facility Registration Additional Capabilities Food

Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) | FDA Skip to main

Including Mobile Medical Applications Wireless Medical Devices Digital Health Software Precertification (Pre-Cert) Pilot Program Home Medical Devices Digital Health Center

2017 Mammography Facility Adverse Event and Action Reports | FDA Skip to main content Skip to

2023 Mammography Facility Adverse Event and Action Reports | FDA Skip to main content Skip to

2018 Biennial Food Facility Registration Renewal Period Webinar | FDA Skip to main content Skip to FDA

2015 Mammography Facility Adverse Event and Action Reports | FDA Skip to main content Skip to

Action Report - December 16, 2016: DeQueen General Hospital Inc. dba DeQueen Medical Center (PDF - 158KB) Mammography Facility Adverse Event and

Inc. Mammography Facility Adverse Event and Action Report - July 26, 2018: Palm Beach Broward Medical Imaging Center Mammography Facility

2019 Mammography Facility Adverse Event and Action Reports | FDA Skip to main content Skip to

Radiology Consultants Mammography Facility Adverse Event and Action Report – December 8, 2022: Missouri Delta Medical Center Mammography Facility Adverse

Report - March 13, 2020: The Breast Institute at JFK Medical Center North Campus Mammography Facility Adverse Event and

2021 Mammography Facility Adverse Event and Action Reports | FDA Skip to main content Skip to

2017 Mammography Facility Adverse Event and Action Reports | FDA Skip to main content Skip to

2023 Mammography Facility Adverse Event and Action Reports | FDA Skip to main content Skip to

as facility’s AB No MEE required No*** Yes Check with accreditation body Yes Same as facility’s AB Same as

FDA when you submit your food facility registration or renewal in the Food Facility Registration Module (FFRM). This

Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices | FDA Skip to

Instructions Update Food Facility Registration Retrieve Food Facility Registration PIN Food Facility Biennial Registration Renewal Food Facility Registration Additional Capabilities Food

and FDA Staff (PDF - 291KB) 21 CFR - Part 821 Medical Device Tracking Requirements Other Helpful Links Medical Device Reporting Home page

ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions | FDA Skip to main content

About Manufacturer and User Facility Device Experience (MAUDE) Database | FDA Skip to main content Skip to

how to determine whether your facility meets the definition of “qualified facility” under part 117 and

Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) | FDA Skip to main

FDA Issues Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing | FDA Skip to

Search for a Certified Facility | FDA Skip to main content Skip to FDA Search

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Search for a Certified Facility | FDA Skip to main content Skip to FDA Search

FSMA Webinar on the Final Rule under FSMA to Update Food Facility Registration | FDA Skip to

ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance

a Certified Facility Mammography Information for Patients Search for a Certified Facility MQSA National Statistics CMS

mammography services. The FDA recommends patients contact Farmbrook Radiology to obtain their medical records. Facility Farmbrook Radiology

Licensed as Biological Products . Searching Medical Device Reports The Manufacturer and User Facility Device Experience (MAUDE) database

Licensed as Biological Products . Searching Medical Device Reports The Manufacturer and User Facility Device Experience (MAUDE) database

Licensed as Biological Products . Searching Medical Device Reports The Manufacturer and User Facility Device Experience (MAUDE) database

Medical Devices Resources for You (Medical Devices) Industry (Medical Devices) Notifications on Data Integrity – Medical Devices Industry (Medical Devices

Patients Industry Health Professionals Federal, State and Local Officials In this section : Medical Imaging Medical X-ray

FDA Issues Update on Cosmetic Product Facility Registration and Cosmetic Product Listing | FDA Skip to main content

time, the FDA recommends that patients contact Capitol Radiology to obtain their medical records. Facility Capitol Radiology

services. The FDA recommends patients contact Advanced Women Imaging to get their medical records. Facility Advanced Women

Announces the Availability of Additional Submission Tools for Cosmetic Product Facility Registration and Cosmetic

to enable the facility to resume providing mammography services. The facility successfully completed the

FDA when you submit your food facility registration or renewal in the Food Facility Registration Module (FFRM). This

FDA Issues Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing | FDA Skip to

Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing | FDA

Guidance for Industry: U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration | FDA Skip to

Mammography Facility Adverse Event and Action Report – August 5, 2022: Watson Imaging Center | FDA Skip to

Mammography Facility Adverse Event and Action Report – August 22, 2023: Phelps Memorial Health Center | FDA Skip

Mammography Facility Adverse Event and Action Report – April 25, 2023: University Park OBGYN, LLC | FDA Skip

to revoke the facility’s application for mammography accreditation. The facility appealed the adverse

Mammography Facility Adverse Event and Action Report – September 6, 2022: Ste. Genevieve County Memorial Hospital | FDA

Mammography Facility Adverse Event and Action Report – March 5, 2024: Stockdale Radiology | FDA Skip to

Texas rescinded the facility’s certificate suspension on December 10, 2020. The facility is currently operational and

Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification

Mammography Facility Adverse Event and Action Report – December 8, 2022: Radiology Consultants | FDA Skip to

the facility agreed to the STX AB’s request. The facility underwent voluntary accreditation suspension

the facility’s application for accreditation, effective August 11, 2021.  The facility did not appeal the

The facility’s accreditation had to be reinstated and the facility had to comply