14 Days Turnaround Time

1,500+ 3P510K Reviews

RTS. 510(k) Simplified.

99% Customer Retention

RTS is an FDA-accredited Third-Party Review Organization (3PRO) that is authorized to review 510(k) submissions for selected low-to-moderate risk medical devices. A 510(k) submitted by a manufacturer to a 3PRO is designated a 3P510k.

RTS was initially accredited by the FDA as a third-party reviewer in 2003.  Since then, we have reviewed more 510(k) submissions than any other 3PRO and have consistently conducted more reviews annually than any other 3PRO in the industry. RTS is subject to an FDA audit every three years.

The FDA created the Third Party Review Program in 1997 to provide medical device manufacturers with an alternative path to getting their products approved for sale in the United States.

The program allows a manufacturer to submit a 510(k) directly to a 3PRO such as RTS instead of to the FDA.  RTS utilizes the same review criteria employed by the FDA to review the 510(k) submission, which typically takes us about 14 days to complete. We then forward the original 510(k) submission along with our review and a recommendation of either “Substantially Equivalent” (SE) or “Not Substantially Equivalent” (NSE) to the FDA.  The Agency is committed to providing a decision on our recommendation within 30 days.

The whole process takes about half the 90-day period the FDA is permitted when it reviews a Traditional 510(k) submission sent in to the FDA directly by a medical device manufacturer.

Approximately 50% of the 510(k)s received by the FDA are eligible for review by a 3PRO. The 510(k) submitter pays the 3PRO for conducting the review; there is no separate payment owed to the FDA.

To determine if your device is eligible for 3PRO review, visit this FDA Product Classification website, enter your “Device,” check the “Third Party Eligible” box, and press the “Search” button.

Contact the FDA 3P Staff.

RTS = Expedited 510(k) Clearances.

RTS = Speed to Market.

Why Choose RTS to Review Your 510(k) Submission?

RTS is the fastest.

RTS is the most experienced.

RTS has a solid customer retention.

RTS = Satisfied Clients Around the World

RTS 510(k) Review Experience since 2003

Anesthesiology Division

  1. Anesthesia Vaporizers
  2. Anesthetic Conduction Catheters
  3. Breathing-Circuit Bacterial Filters
  4. Carbon-Monoxide Gas Analyzers
  5. Diagnostic Spirometers
  6. Esophageal Stethoscope with Electrical Conductors
  7. Nebulizers
  8. Non-Rebreathing Valves
  9. Patient Care Suction Apparatuses
  10. Portable Liquid-Oxygen Units
  11. Portable Oxygen Generators
  12. Pulmonary Function Predicted Value Calculators
  13. Tracheal Tubes (w/wo Connectors)
  14. Ventilatory Effort Recorders

Cardiovascular

  1. Angiographic, Injectors and Syringes
  2. Automated External Defibrillator Systems (RTS is no longer accepting reviews for this device type)
  3. Balloon Inflation Syringes
  4. Blood Pressure Computers
  5. Blood Pressure Cuffs
  6. Catheter Introducers
  7. Catheter Tip Pressure Transducers
  8. Cardiovascular Blood Flow Meters
  9. Cardiac Monitors (Including Cardiotachometer & Rate Alarm)
  10. Compressible Limb Sleeves
  11. Continuous Flush Catheters
  12. Diagnostic Programmable Computers
  13. Electrocardiographs
  14. Electrocardiographs, Telephone Transmitters and Receivers
  15. Embolectomy Catheters / Aspiration Thrombectomy Catheters (RTS is no longer accepting reviews for this device type)
  16. Electronic Stethoscopes
  17. Electronic Clinical Thermometers
  18. Electrosurgical Cutting And Coagulation Device And Accessories
  19. Guidewires
  20. Hydraulic Pneumatic or Photoelectric Plethysmographs
  21. Impedance Plethysmographs
  22. Intraluminal Artery Strippers
  23. Intravascular Diagnostic Catheters
  24. Multi-Function Electrocardiograph Electrodes (RTS is no longer accepting reviews for this device type)
  25. Non-Invasive Blood-Pressure Measurement Systems
  26. Medical cathode ray tube displays
  27. Medical magnetic tape recorders
  28. Neurovascular guidewire catheters
  29. Neurovascular percutaneous catheters
  30. Patient Care Suction Apparatus
  31. Percutaneous catheters
  32. Peripheral Mechanical Thrombectomy with Aspiration Devices (RTS is no longer accepting reviews for this device type)
  33. Percutaneous Retrieval Devices
  34. Percutaneous Catheters For Cutting or Scoring (RTS is no longer accepting reviews for this device type)
  35. Physiological Patient Monitors without Arrhythmia Detection or Alarms
  36. Physiological Monitors Network and Communication Systems (RTS is no longer accepting reviews for this device type)
  37. Radio Frequency Physiological Signal Transmitters and Receivers
  38. Steerable Catheters
  39. Thermal Regulating Systems
  40. Transluminal Angioplasty Peripheral Catheters
  41. Vascular Clamps
  42. Vessel Dilators for Percutaneous Catheterization

Clinical Chemistry

  1. Predictive Pulmonary-Function Value Calculator
  2. Blood Specimen Collection Device

Dental

  1. Calcium Hydroxide Cavity Liners
  2. Caries Detection Device
  3. Cavity Varnishes
  4. Dental Cements
  5. Extraoral Source X-Ray Systems
  6. Impression Material
  7. Intraoral Devices For Snoring and Obstructive Sleep Apnea
  8. Optical Impression Systems for CAD/CAM
  9. Orthodontic Plastic Brackets, Ceramic
  10. Orthodontic Plastic Brackets, Plastic Sequential Aligners
  11. OTC Denture Reliners
  12. Porcelain Powder For Clinical Use
  13. Resin Tooth Bonding Agents
  14. Root Canal Filling Resin
  15. Tooth Shade Resin Materials
  16. Ultraviolet Activator for Polymerization
  17. Ultrasonic Scalers

Ear, Nose & Throat

  1. Auditory Impedance Testers
  2. Bronchoscope Accessories
  3. Bronchoscopes (Flexible or Rigid)
  4. Nasopharyngoscopes (Flexible or Rigid)
  5. Nystagmographs
  6. Calibrator, Hearing Aid / Earphone and Analysis Systems
  7. Tinnitus Maskers

Gastroenterology/Urology

  1. Endoilluminators
  2. Electrosurgical, Cutting & Coagulation Devices & Accessories
  3. Endoscope and Accessories
  4. Endoscopic Electrosurgical Unit And Accessories
  5. Feeding Tubes (RTS is no longer accepting reviews for this device type)
  6. Gastrointestinal Tube and Accessories (RTS is no longer accepting reviews for this device type)
  7. Gastroenterology-urology Biopsy Instruments
  8. Gastroenterology-urology Endoscopic Guidewire (RTS is no longer accepting reviews for this device type)
  9. Hemodialysis System and Accessories (RTS is no longer accepting reviews for this device type)
  10. Led Light Source (RTS is no longer accepting reviews for this device type)
  11. Light Source, Fiberoptic, Routine (RTS is no longer accepting reviews for this device type)
  12. Straight Catheters
  13. Urological Catheters and Accessories
  14. Urological Catheters and Accessories, Urinary Catheter Kit, Excludes HIV Testing

General Hospital

  1. Antistick Syringes
  2. Electronic Clinical Thermometers
  3. I.V. Containers
  4. Fluid Transfer I.V. Sets
  5. Intravascular Administration Sets
  6. Medical Recirculating Air Cleaners
  7. Neonatal Phototherapy Units
  8. Patient Lubricant
  9. Piston Syringes
  10. Physical/Chemical Sterilization Process Indicators
  11. Polymer Patient Examination Gloves
  12. Sharps Containers
  13. Short-term (<30 days) Intravascular Therapeutic Catheters
  14. Single Lumen Hypodermic Needles
  15. Steam Sterilizers
  16. Stopcock, I.V. Sets
  17. Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
  18. Surgical Drapes
  19. Surgical Gowns (RTS is no longer accepting reviews for this device type)
  20. Surgical Masks
  21. Surgical Sponge Counters
  22. Syringe Needle Introducers
  23. Vinyl Patient Examination Gloves

General & Plastic Surgery

  1. AC-Powered Portable Suction Ward Use Apparatus
  2. Biopsy Instruments
  3. Ceiling Mounted Surgical Lights (RTS is no longer accepting reviews for this device type)
  4. Cryosurgical Units & Accessories
  5. Electrosurgical Coagulation Systems for Aesthetic Use
  6. Electrosurgical, Cutting & Coagulation & Accessories
  7. Fat Reducing Low Level Laser
  8. General & Plastic Surgery Laparoscopes
  9. Lipoplasty Suction System for Removal
  10. Microwave Ablation System and Accessories
  11. Negative Pressure Wound Therapy, Powered Suction Pump (RTS is no longer accepting reviews for this device type)
  12. Portable Aspiration Pump (Manual or Powered)
  13. Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
  14. Powered Laser Surgical Instruments
  15. Powered Light Based, Non-Laser Surgical Instruments
  16. Radiological Image Processing Systems
  17. Surgical Devices for Cutting, Coagulation, and/or Tissue Ablation, including Cardiac Tissue
  18. Surgical Exhaust Apparatuses
  19. Electrosurgical Patient Return Electrodes
  20. Ultraviolet Dermatological Lights

Microbiology

  1. Epstein-Barr Virus Serological Reagents
  2. Microbiological Specimen Collection And Transport Devices
  3. Transport Culture Media

Neurology

  1. AC-Powered Goniometers (RTS is no longer accepting reviews for this device type)
  2. Cortical Electrodes
  3. Cutaneous Electrodes
  4. Depth Electrodes
  5. Diagnostic Electromyographs
  6. Electroencephalographs
  7. Electroencephalograph Burst Suppression Detection Software (RTS is no longer accepting reviews for this device type)
  8. External Functional Neuromuscular Stimulators
  9. Intracranial Pressure Monitoring Devices
  10. Full-Montage Standard Electroencephalographs
  11. Neurological Biofeedback Devices (RTS is no longer accepting reviews for this device type)
  12. Neurological Endoscopes (RTS is no longer accepting reviews for this device type)
  13. Neurosurgical Paddles
  14. Non-Normalizing Quantitative Electroencephalograph Softwares
  15. Nystagmographs
  16. Physiological Signal Amplifiers
  17. Powered Inflatable Tube Massagers
  18. Powered Temperature Measurement Devices
  19. Self-retaining Retractors for Neurosurgery
  20. Standard Polysomnograph With Electroencephalographs
  21. Radiofrequency Lesion Probes
  22. Transcutaneous Electrical Nerve Stimulator for Pain Relief
  23. Ventricular Cannulae (RTS is no longer accepting reviews for this device type)

Ophthalmic Devices

  1. Ophthalmic Image Management Systems
  2. Battery-Powered Ophthalmoscopes
  3. AC-Powered Slit-Lamps Biomicroscopes
  4. Intraocular Lens Folders and Injectors

Orthopedics

  1. Arthroscopes
  2. Orthopedic Stereotaxic Instruments (RTS is no longer accepting reviews for this device type)
  3. Neurological Stereotaxic Instruments (RTS is no longer accepting reviews for this device type)

Physical Medicine

  1. Diagnostic Electromyographs
  2. Infrared Lamps
  3. Mechanical Wheelchairs
  4. Powered Inflatable Tube Massagers
  5. Powered Muscle Stimulators
  6. Power Traction Equipments
  7. Powered Wheelchairs
  8. Powered Wheeled Stretchers

Radiology

  1. Cardiovascular Blood Flowmeters
  2. Computed Tomography
  3. Extraoral Source Digital X-Ray Systems
  4. Linear Medical Accelerator (RTS is no longer accepting reviews for this device type)
  5. Mammographic X-Ray Systems
  6. Magnetic Resonance Imaging Systems
  7. Magnetic Resonance Specialty Coils
  8. Magnetic Resonance Spectroscopic Systems
  9. Scintillation (Gamma) Cameras
  10. Radiological Image Processing Systems
  11. Ophthalmic Image Management Systems
  12. Ultrasonic Diagnostic Transducer
  13. Ultrasonic Pulsed Doppler Imaging System
  14. Ultrasonic Pulsed Echo Imaging System
  15. Extraoral X -Ray Units with Timers
  16. X-Ray Cabinet Systems
  17. X-Ray Image-Intensified Fluoroscopic Systems
  18. X-Ray Mobile Systems
  19. X-Ray Solid State Imagers, Flat Panel/Digital Imagers
  20. X-Ray Stationary Systems

Toxicology

  1. Carbon Monoxide Gas Analyzers

Why did the FDA establish Third-Party Review Program?

  To enable the Agency to focus more of its resources on higher risk devices.

  To enable the Agency to focus more of its resources on more complex devices.

  To enhance speed to market for manufacturers of lower risk and less complex devices.

Key Dates in FDA’s Oversight of Medical Devices

1938 – The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes the FDA to bring charges against manufacturers whose medical devices are deemed to be unsafe or defective and against statements, designs, or labeling the agency believes are false or misleading.

1976 – The Medical Device Amendments to the FD&C Act of 1938 allows the FDA to approve medical devices before they are sold in the United States.

1997 – The Food and Drug Administration Modernization Act allows FDA-approved third parties to review 510(k) premarket notification submissions for certain low-to-moderate risk devices, prepare a written review of such submissions, and the forward the reviews, submissions and a recommendation of Substantial Equivalence or Non-equivalence to the FDA for a final determination.

2003 – The FDA authorizes RTS to serve as a 3PRO.

2017 – The FDA Reauthorization Act of 2017 authorizes the FDA to tailor the list of devices eligible for review by 3P Review Organizations. Previously, some complex devices that were ill-suited for the program were 3P review-eligible while other less complex devices that were good candidates for the program were ineligible.

2018 – The FDA publishes 510(k) Third Party Review Program Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations.

2018 – FDA announces a plan to eliminate the routine re-review of 510(k) submissions previously reviewed by a 3PRO and to rely solely on the review and recommendation of the 3P Review Organization, all with a goal of reducing the period of time a 3PRO-reviewed submission takes to be approved by the FDA.

2020 – The FDA finalizes the 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations.

2020 – The FDA re-authorizes RTS to serve as a 3PRO.

 

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