targetarea has been truncated to 244 characters for pre-Stata13
techmeth has been truncated to 244 characters for pre-Stata13
physstate has been truncated to 244 characters for pre-Stata13
def has been truncated to 244 characters for pre-Stata13
Source Text File: foiclass.txt
Source File URL: http://www.accessdata.fda.gov/premarket/ftparea/foiclass.zip
Source Page: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051668.htm
NBER URL:  http://www.nber.org/data/fda-product-code-classification-database.html
by Jean Roth , jroth@nber.org ,  2 Oct 2017
for example, has the CFR for regulation number 880.676 which has product code "BRT"
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=880.6760
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
the device has not yet been classified and the device class listed (1, 2, or 3) is proposed, not final.
If the database does not reference a regulation number,
a product definition and is published in Title 21, Code of Federal Regulations (CFR).
The CDRH database links medical devices to the appropriate regulation that contains
This information identifies the Third Party Review Program(s) for which the device is a candidate.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ThirdParyReview/default.htm
Further information on this program can be found at: Third Party Review
the following codes reflect whether it became eligible under the preexisting program or the expansions program.
When the device is a candidate for Third Party Review under the Accredited Persons program,
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm
Further information on how devices are classified:
For each device, the applicable Medical Specialty panel recommends to CDRH the appropriate device class.
Device Class refers to the level of CDRH regulation of a given device.
For example, to find a specific pump, search on the word "pump" to retrieve all products with the word "pump" in their name.
Therefore, the first word in the device name is usually the best search parameter.
The Device Name uses the format of a noun that is usually followed by one or more adjectives, separated by commas.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
Medical Device Exemptions 510(k) and GMP Requirements