Search Help

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. Use Advanced (fielded) Searching to only search for a particular word or phrase in a particular indexing field. We suggest using this type of search only when using the main page search box does not yield a desired result set. Use caution! Not all fields are available for all records.

Document Number:

When searching for a specific document enter the main part of the number only with the part suffix (e.g. 5206634-A should be entered as 5206634, WL203072A as WL203072). This will ensure that all related parts of a document (if any) are returned by the search.

SubFile:

Indicates general type of document. You may restrict retrieval to:

FDA Log Number:

The number assigned by FDA's Freedom of Information staff office. Will always start with a two digit year followed by the last five digits of the FDA-assigned log number. In format 0107085.

Company Name:

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.

K Number:

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.

Device Classification Code:

Three letter FDA-assigned code corresponding to the classification name. Complete list of codes

PMA Number:

FDA-assigned premarket approval number presented with initial P followed by six digits e.g. P950702

NDA Number:

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.

Approval Date:

Date of approval or substantial equivalence declaration. You may enter only the four digit year.

Trade Name:

Trade (Brand) name(s) for drug(s) discussed in the document. Applies only to drug documents.

Generic Name:

Generic name(s) for drug(s) discussed in the document. Applies only to drug documents.

Begin Date:

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

End Date:

Used to indicate the ending of a referenced event, e.g. the ending date of an inspection or advisory committee meeting. You may also enter only the four digit year. In format mm/dd/yyyy

Docket Number:

FDA-Assigned docket management code, presented as a hyphenated number e.g. 99P-0100

Recall Number:

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

Petition Number:

FDA-Assigned petition management code, presented as a hyphenated number e.g. 98P-0102

Contract Number:

Government assigned contract or grant number.

People:

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

Advisory Committee Name:

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.

General Search Info

Boolean Searching

The default search method on FOI Online is boolean. Begin your search by typing your search terms into the box on the home page. The system will default to the "AND" operator i.e., if you enter venous catheter it will look for documents containing the indexing words venous AND catheter.

To look for documents containing either word, use the "OR" operator.

Phrase Searching

To look for an exact phrase, enclose the terms in double quotes. "venous catheter"

Pattern Searching

If you're not sure how a word is spelled, or would like to account for possible variations in spellings (e.g. British versus American English), you may want to try Pattern Searching. This is particulary effective for drug names or the names of people.

To turn on pattern searching, go to the Query Type box near the bottom of the Advanced Search page and choose Pattern: from the choices in the drop down box. Given the large size of our library, we strongly reccommend that Pattern Seaching be used only in combination with fielded searching to make your result set meaningful. We also suggest setting Hit Highlighting to ON so you can see exactly why a particular document was included in the result set. If there are no hits highlighted it means that the search term (or variant) was found in the underlying text of that document.

Truncation and Wildcards

FOI Online automatically looks for plurals of entered terms. To specify a truncation to match any character or nothing, use the asterisk (*):

The asterisk can also be used as a wildcard within a search term; e.g. orthop*edic will retrieve orthopedic or orthopaedic.