- Background on the Freedom of Information Act (FOIA)
- Records Available From the CDRH Website
- Information Available From Other FDA Resources
- Submitting a FOIA request
- Pre-Disclosure Notification (PDN)
- Newly Posted
The Freedom of Information Act (FOIA) is a federal statute that generally requires federal agencies to disclose records in the possession or control of the agency when requested in writing by any person. FOIA establishes a presumption that records are accessible to the public, except when the records are covered by one or more of the nine exemptions contained in the Act, or are excluded from the Act’s coverage by one of the three special law enforcement exclusions. Each federal agency is responsible for meeting its FOIA responsibilities for its own records.
For more information, you can find the text of the Act, including changes made by the FOIA Improvement Act of 2016, on the U.S. Department of Justice website.
CDRH makes a variety of information and records available through its Internet site. Before CDRH created this site, many of the records disclosed on our website could only be obtained by submitting a FOIA request and paying certain fees. Before you submit a FOIA request, please check our website to see if the records you need are already available for free on our website.
The general rule under FOIA is that a release to one is a release to all. In accordance with that principle, since 510(k) applications are the most frequently requested CDRH records, CDRH is posting 510(k) records released to the public through FOIA in our 510(k) database. Are you looking for a 510(k)? We recommend you search the 510k database first, prior to submitting a FOIA request.
Some types of records may be viewed by simply clicking on a link. Other records require a search: you specify certain criteria to describe the information you need and retrieve either the information or a set of links leading to the information.
|Type of Information||Format|
|Releasable 510(k)s||Searchable and ZIP|
|Releasable PMAs||Searchable and ZIP|
|Product Code Data||Searchable and ZIP|
|Adverse Events||Some Searchable and ZIP|
|Registration and Listing Data||Searchable and ZIP|
|Certified Mammography Facilities||Searchable|
|FDA Recognized Consensus Standards||Searchable|
|CLIA||Some Viewable Directly|
|X-Ray Assembler||Searchable and ZIP|
Certain materials about CDRH-related matters for public distribution (e.g., press releases, consumer updates, speeches, congressional testimony) are available from the FDA Internet site. Some materials are also available from the more than 40 FDA public affairs specialists throughout the United States.
FDA also maintains accessible electronic FOIA libraries, or "electronic reading rooms," as they used to be called, with agency FOIA response materials and other information routinely available to the public, with electronic search and indexing features.
If the records you seek are not available from any of the above sources, you may submit a written Freedom of Information Act (FOIA) request to FDA’s Division of Freedom of Information (DFOI). You may even submit a FOIA request online. CDRH is not able to accept FOIA requests directly, as FDA DFOI is the only entity designated in our regulations to receive FOIA requests. The FDA DFOI contact information for submitting a request via mail or fax can be found on the following page: How to Make a FOIA Request.
Pre-Disclosure Notification Process - Information for Submitters/Owners of Business Records submitted to CDRH
Given the nature of CDRH records, we frequently encounter records that may contain trade secrets or confidential commercial information potentially subject to FOIA exemption 4. Exemption 4 of the Act protects from public release “trade secrets and commercial or financial information obtained from a person and privileged or confidential.” (5 U.S.C. § 552 (b)(4)).
This exemption protects the interests of both the government and the submitter/owner of the information. It encourages submitters to provide the government with confidential information that is accurate and reliable, and provides assurances to submitters that the information will be safeguarded appropriately, protecting submitters from potential competitive disadvantage.
We make reasonable efforts to provide pre-disclosure notification (PDN) to submitter's of the receipt of FOIA requests for records in which the submitter may have a commercial interest, where disclosure “could reasonably be expected to cause substantial competitive harm,” as required by Executive Order 12,600. Through the PDN process, we solicit submitter input on whether disclosure would likely cause substantial competitive harm. The FDA implementing regulations outlining the PDN process are found at 21 C.F.R. § 20.61.
A sponsor of a 510(k) will typically receive a package from CDRH explaining that we've received a FOIA request for records which may have a commercial interest, citing to the applicable regulations, and offering the opportunity for you to identify specifically (by page, line, column, paragraph, etc.) any portion of the records you believe may meet the requirements of exemption 4. That package will contain a copy of the FOIA request, and a copy of the responsive records. CDRH will review the records for public release prior to sending them to you for review. However, there may be limited exceptions where CDRH sends the submitter/owner of records a clean copy of your records and requests that you review them first.
The sponsor of a 510(k) is under no obligation to respond to the PDN request from CDRH. If a record submitter/owner does not respond to the PDN, CDRH will review the records and redact trade secret and commercial confidential information according to Exemption 4 and respond to the FOIA request. If the sponsor intends to respond to the PDN, , we encourage submission of a detailed, written justification as to how release of the records would cause harm to the sponsor's competitive position. Please keep in mind that FOIA is a disclosure statute, and general objections to public release stating that all information was submitted in confidence and must be denied are unlikely to be sustained.
How can I find out the outcome of an allegation of regulatory misconduct submitted to the FDA?
Requests for records pertaining to completed investigations can be submitted pursuant to the Freedom of Information Act (FOIA). Please note FOIA does not require agencies to create new records or to conduct research, analyze data, or answer questions posed as FOIA requests.
Please note that investigations may not be finalized for at least 180 days after submission of allegations of regulatory misconduct.
As such, we recommend waiting at least 180 days after submitting your allegations to submit a FOIA request for related records, if you wish to do so.
Should you wish to submit a FOIA request for FDA records, the contact information for submission of a request to the FDA Division of Freedom of Information, the sole entity designated in our regulations to receive FOIA requests, is located on this page: How to make a FOIA request.
Assistance from CDRH FOIA
If you are considering submitting a FOIA request for CDRH records, we encourage you to first check our website to see if the records are already available online. If you do not find what you are looking for on our website or have questions regarding submission of a FOIA request, we are happy to be of assistance, including helping you formulate the scope of your FOIA request.
To contact us with questions or to check the status of an existing FOIA request, please call 301-796-8118 or email us at CDRH-FOIStatus@fda.hhs.gov.
We encourage you to contact us directly to discuss issues related to the processing of your FOIA request. You also have the right to contact the Department of Health and Human Services (HHS) FOIA Public Liaison to assist you with disputes or problems related to the processing of FOIA requests. You can find the contact information for the HHS FOIA Public Liaison on the FOIA Contacts & Requester Service Centers and Privacy Act Contacts Website.
Essure Frequently Requested Records
- ESSURE Original Premarket Approval (PMA) Application (PDF - 90MB)
- ESSURE Medical Device Reporting Variance Spreadsheet - March 2021
- ESSURE Medical Device Reporting Variance Spreadsheet - February 2021
- ESSURE Medical Device Reporting Variance Spreadsheet - January 2021
- ESSURE Medical Device Reporting Variance Spreadsheet - December 2020
- ESSURE Medical Device Reporting Variance Spreadsheet - November 2020
- ESSURE Medical Device Reporting Variance Spreadsheet - October 2020
- ESSURE Medical Device Reporting Variance Spreadsheet - September 2020
- ESSURE Medical Device Reporting Variance Spreadsheet - August 2020
- ESSURE Medical Device Reporting Variance Spreadsheet - July 2020
- ESSURE Medical Device Reporting Variance Spreadsheet - June 2020
- ESSURE 36 Month Interim Postmarket Surveillance Study Report - September 2019
- ESSURE Medical Device Reporting Variance Request - April 2020
- ESSURE 30 Month Interim Postmarket Surveillance Study Report - March 2019
- ESSURE 24 Month Interim Postmarket Surveillance Study Report - September 2018
- ESSURE 18 Month Interim Postmarket Surveillance Study Report - March 2018
- ESSURE 12 Month Interim Postmarket Surveillance Study Report - September 2017
- ESSURE 6 Month Interim Postmarket Surveillance Study Report - March 2017
- ESSURE-ESS305-PAS-Dec2007-6 months
- ESSURE-ESS305-PAS-Dec2008-18 months
- ESS305-PAS-Jun2008-12 months
- ESSURE-ESS-NSPAS-Aug2013-18 months
- ESSURE-ESS-NSPAS-Dec2012-6 months
- ESSURE-ESS-NSPAS-Mar2013-12 months
- ESSURE-ESS-NSPAS-Mar2014-24 months
- ESSURE-ESS-NSPAS-Mar2014-24 months (2)
- ESSURE-ESS-NSPAS-Sept2013-18 months
- ESSURE-ESS-PAS-Newly Trained Physicians-July2005
- ESSURE-ESS-PAS-Phase II Clinical Study Final Report-Jun2006
- ESSURE Maude Reports
This FOIA response contains content that is not fully supported by assistive technology, but on-demand assistance is available - please contact the CDRH Division of Information Disclosure at Cdrhfirstname.lastname@example.org.
- DEN180042 - Irregular Rhythm Notification Feature
- DEN180044 - ECG App
- Opternative Warning Letter Response - Letter issued 09-21-18
- Custom Ultrasonics, Inc. - Ivyland, Pennsylvania - Letter issued 1-29-2016
- Recall Order to Custom Ultrasonics Under Consent Decree of Permanent Injunction
- Custom Ultrasonics, Inc. - Ivyland, Pennsylvania - 483 issued 04-24-2015
- Aizu Olympus Co. Ltd - Aizuwakamatsu-City, Fukushima, Japan - 483 Issued 04-17-2015
- Fujifilm - Ashigarakami Gun, Japan - 483 Issued 05-01-2015
- Fujifilm - Hitachiomiya City, Japan - 483 Issued 04-20-2015
- FujiFilm Optics Co - Sano City, Tochigi, Japan - 483 Issued 04-22-2015
- Hoya (Pentax) Life Care Division - Kurihara-shi, Miyagi, Japan - 483 Issued 04-24-2015
- Hoya (Pentax) Corp - Akishima-shi, Japan - 483 Issued 04-21-2015)
- Olympus Medical Systems Corp - Hachioji-Shi, Japan - 483 Issued 04-24-2015