Smith Associates’ history over 23 years with CDRH and CBER Divisions of the FDA has been extremely productive for our clients. Below is an overview by Branch of the many projects we have either completed or are currently under review.

Anesthesiology Branch

General and Plastic Surgery Branch

Cardiovascular Branch

General Hospital Branch

Home Use Products

  • Ostomy Bag Mobile App
  • Diagnostic Spirometer for all ages
  • Blood Glucose Meters for all ages
  • Blood Glucose Management Software
  • Atrial Fibrillation Monitor
  • Blood Pressure Monitors
  • Peak Flow Meters
  • Arterial Hardenss and Blood Pressure Monitor
  • Blood Pressure Monitors
  • Blood Glucose Test Strip
  • Automatic Thermal Massager
  • Vital Sign Recorder and Transmitter
  • Negative Pressure Wound Foam Dressing
  • Colon Rectal Screening Test
  • Clinical Thermometer
  • Anti Snoring Device
  • TENS
  • Breast Pumps
  • Tampon
  • Condoms
  • Menstrual Cup
  • Kegel Exerciser
  • External Penile Rigidity Device
  • Personal Lubricant
  • Latex Examination Gloves
  • Nitrile Examination Gloves
  • Contact Lens Product
  • Apnea Examination System

Neurology Branch

Gastroenterology Branch

In-Vitro Diagnostic Branch

Ear, Nose, & Throat Branch

  • Defibrillator Tester
  • Transient Evoked Otoacoustic Distortion
  • Product Emission System
  • Echoport
  • Nasal Retainer
  • ILO288 Echoport plus OAE System Otocheck
  • ILO292 Echoport plus OAES
  • Audiometer
  • Laryngeal Electrode
  • ENT Electric surgical drill

Obstetrics/Gynecology Branch

  • Sonicaid System 8002 – Fetal Heart Rate Analysis Software
  • Mini-Manual Breast Pump (OTC)
  • Automatic Breast Pumps (OTC)
  • Micro Filter for Breast Pumps (OTC)
  • Vaginal Speculum
  • Vaginal Stent
  • Cervical Spatula
  • Umbilical Clamp
  • Condoms (OTC)
  • Kegel Exerciser (OTC)
  • Perineometer
  • Patient Lubricant
  • Organic Cotton Tampon (OTC)

Radiology Branch

Dental Branch

  • Caraloe Oral Rinse (OTC)
  • Dental Casting Alloys
  • Precious Metals Bonding Alloys
  • Anti-Snoring Device
  • Orthodontic Bracket

Ophthalmic Branch

  • Contact Lens Case (OTC)
  • Punctum Plug

CBER Division

  • Reveal™ Rapid HIV Test Kit (PMA cleared April 2003)
  • Disc Stem Cells BLA

Physical Medicine

  • Relfex Gun
  • Thermal Massager
  • Mechanical Wheelchair

IDE/PMA Projects

  • Saline Mammary Implants
  • Gel Mammary Implants
  • Polyurethane Mammary Implants
  • Testicular Implants
  • Rapid HIV Test Kits
  • Treatment IDE
  • Compassionate IDE
  • ADHD In Vitro Diagnostic Test
  • Hepatitis B Antigen Test
  • Hepatitis B Core Antibodies Test

We service all sized companies and classifications within your budget.