_dta: 1. by Jean Roth , jroth@nber.org , 12 Oct 2018 2. NBER URL: http://www.nber.org/data/fda-product-code-classification-database.html 3. Source Page: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051668.htm 4. Source File URL: http://www.accessdata.fda.gov/premarket/ftparea/foiclass.zip 5. Source Text File: foiclass.txt 6. def has been truncated to 244 characters for pre-Stata13 7. physstate has been truncated to 244 characters for pre-Stata13 8. techmeth has been truncated to 244 characters for pre-Stata13 9. targetarea has been truncated to 244 characters for pre-Stata13 devname: 1. The Device Name uses the format of a noun that is usually followed by one or more adjectives, separated by commas. 2. Therefore, the first word in the device name is usually the best search parameter. 3. For example, to find a specific pump, search on the word "pump" to retrieve all products with the word "pump" in their name. devclass: 1. Device Class refers to the level of CDRH regulation of a given device. 2. For each device, the applicable Medical Specialty panel recommends to CDRH the appropriate device class. 3. Further information on how devices are classified: 4. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm gmpexempt: 1. Medical Device Exemptions 510(k) and GMP Requirements 2. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm thirdparty: 1. When the device is a candidate for Third Party Review under the Accredited Persons program, 2. the following codes reflect whether it became eligible under the preexisting program or the expansions program. 3. Further information on this program can be found at: Third Party Review 4. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ThirdParyReview/default.htm revcode3: 1. This information identifies the Third Party Review Program(s) for which the device is a candidate. regnum: 1. The CDRH database links medical devices to the appropriate regulation that contains 2. a product definition and is published in Title 21, Code of Federal Regulations (CFR). 3. If the database does not reference a regulation number, 4. the device has not yet been classified and the device class listed (1, 2, or 3) is proposed, not final. 5. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm 6. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=880.6760 7. for example, has the CFR for regulation number 880.676 which has product code "BRT" obs: 5,691 vars: 23 12 Oct 2018 13:25 size: 6,487,740 (_dta has notes) ------------------------------------------------------------------------------------------------------------------------------------------- storage display value variable name type format label variable label ------------------------------------------------------------------------------------------------------------------------------------------- revpanstr str2 %9s Review Panel String revpan int %38.0g medspec Review Panel String medspecstr str2 %9s Medical Specialty String medspec int %38.0g medspec Medical Specialty String prodcode str3 %9s Product Code devname str120 %120s * Device Name devclassstr str1 %9s Device Class devclass int %88.0g devclass * Device Class unclass byte %35.0g unclass Unclassified Reason Code gmpexempt str1 %9s * Good Manufacturing Practice (GMP) Exempt Flag thirdpartystr str1 %9s Third Part Review Flag String thirdparty byte %59.0g thirdparty * Third Part Review Flag String revcode3str str1 %9s Third Party Review Code String revcode3 byte %60.0g revcode3 * Third Party Review Code String regnum float %9.0g * Regulation Number typeid byte %35.0g typeid Submission Type ID def str244 %244s Definition physstate str244 %244s Physical State techmeth str244 %244s Technical Method targetarea str244 %244s Target Area implant str1 %9s Implant Flag lifesust str8 %9s Life Sustain Support Flag summarymalfunctionreporting str10 %10s SummaryMalfunctionReporting * indicated variables have notes ------------------------------------------------------------------------------------------------------------------------------------------- Sorted by: prodcode medspec: 6578 Anesthesiology Part 868 AN 6772 Clinical Chemistry Part 862 CH 6786 Cardiovascular Part 870 CV 6869 Dental Part 872 DE 6978 Ear, Nose, & Throat Part 874 EN 7185 Gastroenterology & Urology Part 876 GU 7269 Hematology Part 864 HE 7279 General Hospital Part 880 HO 7377 Immunology Part 866 IM 7771 Molecular Genetics MG 7773 Microbiology Part 866 MI 7869 Neurology Part 882 NE 7966 Obstetrics/Gynecology Part 884 OB 7980 Ophthalmic Part 886 OP 7982 Orthopedic Part 888 OR 8065 Pathology Part 864 PA 8077 Physical Medicine Part 890 PM 8265 Radiology Part 892 RA 8385 General & Plastic Surgery Part 878 SU 8488 Clinical Toxicology Part 862 TX medspec: 6578 Anesthesiology Part 868 AN 6772 Clinical Chemistry Part 862 CH 6786 Cardiovascular Part 870 CV 6869 Dental Part 872 DE 6978 Ear, Nose, & Throat Part 874 EN 7185 Gastroenterology & Urology Part 876 GU 7269 Hematology Part 864 HE 7279 General Hospital Part 880 HO 7377 Immunology Part 866 IM 7771 Molecular Genetics MG 7773 Microbiology Part 866 MI 7869 Neurology Part 882 NE 7966 Obstetrics/Gynecology Part 884 OB 7980 Ophthalmic Part 886 OP 7982 Orthopedic Part 888 OR 8065 Pathology Part 864 PA 8077 Physical Medicine Part 890 PM 8265 Radiology Part 892 RA 8385 General & Plastic Surgery Part 878 SU 8488 Clinical Toxicology Part 862 TX devclass: 1 Class 1 - Devices subject to General Controls 2 Class 2 - Devices subject to General Controls and Special Controls 3 Class 3 - Devices subject to General Controls, Special Controls, and Premarket Clearance 78 Not Classified 85 Unclassified 102 HDE - Humanitarian Device Exemption unclass: 1 Pre-Amendment 2 IDE 3 For Export Only 4 Unknown 5 Guidance Under Development 6 Enforcement Discretion 7 Not FDA Regulated 9 HDE - Humanitarian Device Exemption 11 EUA - Emergency Use Authorization thirdparty: 78 N = Not Eligible for Accredited Persons Program 80 P = Eligible for Accredited Persons Expansion Pilot Program 89 Y = Eligible for Accredited Persons Program revcode3: 65 A = Candidate for Accredited Persons Program (APP) 66 B = Candidate for both APP and MRA Programs 77 M = Candidate for Mutual Recognition Agreement (MRA) Program typeid: 1 1 - 510(K) 2 2 - PMA 3 3 - Contact ODE 4 4 - 510(K) Exempt 6 HDE - Humanitarian Device Exemption 7 Enforcement Discretion 8 EUA - Emergency Use Authorization