CDRH SuperSearch User Instructions
What does SuperSearch do?
SuperSearch provides one place where you can find official information about FDA cleared and approved medical devices.
You can use SuperSearch to:
- Find out if and when medical devices were cleared or approved by FDA
- Read summaries of medical devices currently on the market
- Get phone numbers and addresses of medical device companies
- Read and print patient information and instructions for use
- Learn about changes to devices since they were approved
What products are in SuperSearch?
SuperSearch contains all products found in the PMA, 510(k), Device Listing, Recognized Consensus Standards, Code of Federal Regulations Title 21, Establishment Registration, Good Guidance Practices, Products Classification and Clinical Laboratory Improvement Amendments databases. This includes all medical devices that were reviewed and cleared or approved by FDA.
What products are not in SuperSearch?
FDA does not review every medical device. Some lower-risk devices are "exempt" from FDA review if they meet certain criteria. Those devices are not in SuperSearch.
What information is available for each product in SuperSearch?
For each product, you can find:
- Device name
- Device summary information
- Date approved or cleared
- Summary of safety and effectiveness (when available)
- Professional and patient user instructions (when available)
- Any FDA-prepared consumer information (when available)
- Any supplements (changes) to a PMA product since it was first approved
How do the searches work in SuperSearch?
When you enter a search term in SuperSearch, the program searches FDA databases to find the search term in the device name, company, or summary information. It returns all records containing the search term.
- Your search term can be the exact name of a specific device, or it can be a more generic, common name for a category of devices (i.e. pacemaker).
- Search terms are not case sensitive.
For example, search terms like MediValv, medivalv, Medivalv and MEDIVALV will all find the same set of records.
- Normally, SuperSearch uses a process called stemming to find your search term. In stemming, all words that are based on your search term are also included.
For example, if you Search with hear, you will get all records that have one or more words that stem from hear, like hears or hearing. You will not get records that have heart in them because hear is not a stem of heart.
- Or, you may use an * to indicate that you would like SuperSearch to search all words containing your original search term and not use stemming. This is a good strategy to use if you are not exactly sure what a device is called. You may use * at the beginning, end, or beginning and end of your search term.
For example, if you search with hear*, you will get all records that have one or more words that start with hear, such as hear, heart, hearing, hears and hearth. If you search with *ear you will words that end in ear, such as clear, hear, smear, etc, but not heart, hearing, hears, and hearth. If you search with *ear* you get records that have one or more words with ear somewhere in them, such as clear, hear, smear, heart, hearing, hears, hearth, etc.
As yet another example, if you are interested in finding all angiography devices, they may be listed under angiogram, angiography, or angiographic device. If you entered angiogr* you would get all of the devices. If you entered angiogram, you would get only some of the devices.
- Trade names are often made-up words. If you are not sure of the spelling of a trade name for a specific device, you should add the * following 3-5 letters of the word rather than guessing at the spelling of the trade name.
For example, if you want to find the device Medivalv, you would not find the record if you entered Medivalve, but you would it if you searched with Medi*.
- You may enter more than one word in the search box if you would like to limit your search to records that contain all words.
For example, if you search with heart valve, you will get only those records that have both heart and valve in them. The records do not have to have the words near each other in the record.
- The program automatically includes all approval dates. If you like, you can select a time period of device approval.
- The program automatically returns 10 records per page. You can change this to a different number if you like.
- The program automatically sorts your results by approval date. You can change this to sort by device name if you like.
Once you have entered your search conditions, click on "Search." Depending on your internet connection, it may take up to several minutes to complete your search.
How are the results displayed?
You will receive a list of up to the 3 first records meeting your search criteria from each database. From this list, you can select the link titled more for further information. If you would like display the entire list from each database, select the link titled Complete Results.
How can I get further assistance?
If you have questions or feedback about SuperSearch, please use this link to contact us: http://www.fda.gov/cdrh/comment5.html.