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FDA Identifies 21 Devices as Candidates for Reclassification

In 2014, the U.S. Food and Drug Administration (FDA) reviewed 69 percent of medical device product codes subject to post-market approval (PMA) and identified 21 of them as candidates for reclassification from class III (high risk) to class II (moderate risk).   One of the agency’s strategic goals for 2014 and 2015 was to “assure the appropriate balance between premarket and postmarket data requirements to facilitate and expedite the development and review of medical devices, in particular high-risk devices of public health importance.”  To accomplish this goal, FDA decided to review medical devices subject to PMA to determine whether or not to reclassify or change the premarket requirements for some of the devices.

Originally FDA’s goal was to review 50 percent of product codes subject to PMA in 2014 and the other 50 percent by the end of 2015.  The agency may complete their review of the remaining devices earlier than expected, as they surpassed their target for 2014. FDA has not yet indicated what its subsequent regulatory steps will be once its review is complete.  Below are the 21 product codes identified as being candidates for reclassification thus far:

  • LFD                         Saliva, artificial
  • LLX                         Catheter, sampling, chorionic villus
  • LMF                       Agent, absorbable hemostatic, collagen based
  • LNC                        Applicator, hyperthermia, superficial, rf/microwave
  • LOA                        Device, testicular hypothermia
  • LOB                        Dilator, cervical, synthetic osmotic
  • LOC                        System, rf/microwave hyperthermia, cancer treatment
  • LOF                        Bone growth stimulator
  • LPQ                        Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
  • LTF                         Stimulator, salivary system
  • LZR                         Ultrasound, cyclodestructive
  • MBU                      Condom, female, single-use
  • MRK                      System, imaging, fluorescence
  • MVF                      System, laser, photodynamic therapy
  • MVG                     System, laser, fiber optic, photodynamic therapy
  • MYL                       Assay, enzyme linked immunosorbent, parvovirus b19 igg
  • MYM                     Assay, enzyme linked immunosorbent, parvovirus b19 igm
  • MYN                      Analyzer, medical image
  • NXG                       Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
  • NZC                        Stent, urethral, prostatic, semi-permanent
  • OAY                       Light source system, diagnostic endoscopic

Devices that are reclassified to class II will no longer be subject to PMA, but may be subject to premarket notification (510(k)).  510(k) submissions allow FDA to determine whether a new device is substantially safe and equivalent to a device already on the market.

Registrar Corp assists medical device companies with U.S. FDA regulations.  We can help determine the classification of a device, as well as assist in developing or reviewing a 510(k). For assistance with FDA regulations for medical devices, contact Registrar Corp at +1-757-224-0177 or live help is available 24 hours a day at www.registrarcorp.com/livehelp.