General Search Information
When searching the FOI Online library always start with the search box on our home page. Search terms entered there will be searched across all fields. The system will default to the "AND" operator i.e., if you enter venous catheter it will look for documents containing both words: venous AND catheter. To look for documents containing either word, use the "OR" operator. To look for an exact phrase, enclose the terms in double quotes: "venous catheter". To search for a partial word, you may also use an asterisk as a wildcard. i.e. catheter* will find records that use the term "catheter," "catheters," or "catheterization".
If this search returns a large number of hits, simply add another term to your search to narrow it. Use advanced search only when you need to limit a search term to a particular field. Use caution! Not all fields are available for all records.
Use the following formats for searching numbers:
- NDA and ANDA Numbers e.g. N20974 (always starts with N)
- 510(k) Numbers e.g. K981234
- PMA Numbers e.g. P870015
- Veterinary Drugs e.g. V14107
- Biologics e.g. B981396
- Biologic 510(k) e.g. BK991234
- If you already know the document number, enter it without the tailing letter. e.g. 5211942-A should be entered as 5211942; KJ10725A shold be entered as KJ10725. this will allow you to see all related parts (if any) for that document.
Searching Dates and Date Ranges
Enter dates in mm/dd/yyyy format. Remember these are unpublished documents and may not have a specific date attached to them, so try starting out by just entering the four digit year.
You can easily restrict your search to a time range by including the search term YYYY:YYYY (e.g. 2000:2002 looks for documents between 2000 and 2002).
Searching People's Names
FDA and/or company individuals named in the document, such as FDA investigators involved in an inspection, company representatives speaking at an advisory committee meeting, FDA approval application reviewers often appear in various fields so always start by entering the person's last name in the main search box first.
When searching for a particular company location (i.e. inspection site) start by limiting your search to the company name and two character state abbreviation for domestic locations or the company name and country for non-US locations. Add the city to your search if the result set is too large.
Searching Device Codes
When the 510(k) you are looking for is not available on FOI Online, try searching using the FDA assigned three letter device code. This will bring up 510(k)s with the same classification that are available now. This search works best using the DeviceCode field on the advanced search page. For a complete list of the codes (as of 2/5/2020) right click here and choose the save option.
Searching Specific Fields
Contains the name of the company discussed in the document. Generally, only significant portions of the company name are included; do not include terms like "Inc." or "Co." in your search. For clinical investigator EIRs, this field includes the name of the clinical investigator.
FDA-assigned device 510(k) number presented with initial K followed by six digits e.g. K990709 Biologic 510(k)s are presented with an initial BK followed by six digits.
Three letter FDA-assigned code corresponding to the classification name. Complete (as of 2/5/2020) list of codes
FDA-assigned premarket approval number presented with initial P followed by six digits e.g. P950702
This field includes the Drug Application Number, when known. NDA and ANDA numbers are entered with an initial N followed by five digits e.g. NDA #20-262 is searched as N20262. Veterinary application numbers begin with V; Biologic application numbers begin with B.
Date of approval or substantial equivalence declaration. You may enter only the four digit year.
Trade (Brand) name(s) for drug(s) discussed in the document. Applies only to drug documents.
Generic name(s) for drug(s) discussed in the document. Applies only to drug documents.
Used to indicate the beginning of a referenced event, e.g. the beginning date of an inspection or advisory committee meeting. You may also enter only the four digit year. In format mm/dd/yyyy
FDA-Assigned docket management code, presented as a hyphenated number e.g. 99P-0100
FDA-Assigned recall tracking number presented with a leading # sign and internal hyphenation, e.g. #Z-000-2. The letter indicates the product recalled: Z=Device recall; D=Drug recall; B=Biologic recall
FDA-Assigned petition management code, presented as a hyphenated number e.g. 98P-0102
Government assigned contract or grant number.
FDA and/or company individuals named in the document, such as FDA investigators involved in an inspection, company representatives speaking at an advisory committee meeting, FDA approval application reviewers. Always start your search with just the last name of the individual
The full name of the advisory committee is included for advisory committee meeting minutes and transcripts. If known, the advisory panel name is included for device approvals and 510(k)s. A list of committee names as we use them is available.