- FDA and PRF
FDA and PRF
FDA and PRF
FDA requirements for PRF
FDA classification for medical devices
The Food and Drug Administration (FDA) has established classifications of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are:
Medical Device Class and Regulatory Controls
1. Class I General Control: Lowest risk. Considered the safest medical devices. Most of class I medical devices are required to be listed or registered at the FDA medical establishments registration and listing facilities and do not require a premarket notification 510k clearance from the FDA. An example of a Class I device is a manual toothbrush, bone graft material, Centrifuge, Plain non additives, no silica coating blood collection tubes(vacuum assisted), hand dental instruments, PRF box, blood bank pipettes, blood grouping slides,tissue culture flasks, disks, tubes, blood typing tubes, blood typing racks, and cold packs for antisera reagents.
2. Class II General Controls and Special Control. Moderate risk. Considered as moderate risk devices. Most Devices in this group require a 510k clearance from the FDA; Premarket notification 510k process is an special registration process that can be completed for a medical device using a predicate device (Device with similar uses, that has being marketed before). An example of a class II device is a syringe with Needle, butterfly needle set, Laboratory blood collection tubes with additives and/or with silica or chemicals coating inside the tube.
3. Class III General Controls and Premarket Approval: highest risk. Devices that are not within a type marketed before the date of the Medical Device Amendments of 1976 – referred to preamendments devices – are classified into class III automatically under federal law.. In addition, the FDA classifies into class III devices intended to be used in supporting or sustaining human life or preventing impairment of human health, or that may present a potential unreasonable risk of illness or injury for which general controls and special controls are insufficient to provide reasonable assurance of the safety and effectiveness of a device, or for which there is insufficient information to make such a determination. Devices class III, need to follow special registration process with medical trials.
Boca Dental Supply,LLC. is a corporation registered at the FDA industry system with establishment number 3005888708. Under FDA's Boca Dental Supply establishment facility number, we have registered the centrifuge, dental instruments, plain tubes as class I medical devices and also blood collection tubes with additives and silica coating for laboratory use only as class II medical devices.
The butterfly needle sets that Boca Dental Supply, LLC sells have a 510k clearance from the FDA under the manufacturer GBO - Greiner Bio-One.
Boca Dental Supply,LLC centrifuge and supplies are in compliance with FDA regulations. Any dentist, dental practice, medical facility, dental school and government institution can legally purchase some or all the supplies that we sell. All devices that Boca Dental Supply, LLC sells are FDA registered or/and 510k FDA cleared as required by the FDA. See Boca Dental Supply registered list with the FDA HERE
For more information visit the official FDA website Click here
All doctors should be aware that any medical device with a 510k clearance is subject to general controls and special controls by the FDA and the manufacturer is obligated to follow all federal regulations and FDA protocols including voluntary and mandatory recall when a needed. Doctors should also be aware that a 510k clearance is not a guarantee that the device is safe, specially, if the manufacturer does not follow all federal regulations. FDA recalls in the year 2016 were 3,252 medical devices due to safety reasons and/or preventive measurements by manufactures voluntary recall when an issue could not be fixed properly.
If you want to search a company products at the FDA go here: -FDA seach medical devices here Just type the name of the company at the owner/operator tab and search for the company listings at the FDA....then you can follow the links to see if the product is cleared for PRF(blood Bank) or lab purposes. Regulations for blood bank are not the same as per Lab.
The FDA has a program now called "NO FEAR REPORTING" to encourage professionals to report a medical device safety issue to the FDA and the identity of the person sending the report will be kept confidential.
Report a medical device safety issue here: The FDA Safety Information and Adverse Event Reporting Program :http://www.fda.gov/Safety/MedWatch/default.htm
With a 510k aproval the FDA submits to the aplicant a letter and most FDA clearance letters include the following statement: "Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Search FDA recalls Here: you can see how many and what devices with 510k clearance have caused death or damage to patients. Meaning that a 510k clearance or approval is not a guarantee of safety if the manufacturer does not comply with the regulations.
See list of FDA recalls in 2016 here All recalled devices had 510k clearance and most were recalled for safety reasons.
Important FDA Links:
FDA Medical device bans: http://www.fda.gov/MedicalDevices/Safety/MedicalDeviceBans/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
- Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS): http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082196.htm
-FDA seach medical devices here Just type the name of the company at the owner/operator tab and search for the company listings at the FDA....then you can follow the links to see if the product is cleared for PRF(blood Bank) or lab purposes.
For example, Our Boca Dental Supply listings and registration at the FDA here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm?start_search=1&showList=1&establishmentName=®Num=&StateName=&CountryName=&OwnerOperatorNumber=&OwnerOperatorName=boca%20dental%20supply&ProductCode=&DeviceName=&ProprietaryName=&establishmentType=&PAGENUM=10&SortColumn=EstablishmentName20%25ASC&RegistrationNumber=3005888708
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