Apr 30, 2015

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has identified 21 medical device product codes as candidates for reclassification from Class III to Class II as part of a broad review of pre- and post-market data collection processes.

Balancing pre- and post-market data collection is one of the FDA’s previously announced strategic goals for 2014 and 2015. The agency had set a goal of reviewing 50% of all device product codes requiring Premarket Approval (PMA) by December 2014, but now reports that it surpassed that goal; 69% of all device product codes subject to PMA were actually reviewed by CDRH last year.

Among the product codes US regulators identified as eligible for down-classification to Class II are:

  • LFD (saliva, artificial)
  • MBU (condom, female, single-use)
  • LOA (device, testicular hypothermia)
  • MRK (system, imaging, fluorescence)
  • LOF (bone growth stimulator)
  • MYN (analyzer, medical image)
  • LTF (stimulator, salivary system)
  • NZC (stent, urethral, prostatic, semi-permanent)
  • LZR (ultrasound, cyclodestructive)
  • OAY (light source system, diagnostic endoscopic

CDRH reviewers also identified 21 product codes for which premarket data requirements will be reduced; instead, regulators will rely more on post-market data for affected devices. Examples of product codes for which changes to premarket data requirements have been proposed include:

  • FTR (prosthesis, breast, noninflatable, internal, silicone gel-filled): FDA may loosen clinical trial and data requirements for this product code
  • MNM (reader, cervical cytology slide, automated): Regulators may increase post-market data requirements in order to avoid or reduce pre-market clinical study requirements
  • MTF (total, prostate specific antigen for detection of prostate cancer): FDA may increase requirements for performance and/or non-clinical test data in lieu of clinical data
  • OAD (catheter, percutaneous, cardiac ablation, for treatment of atrial flutter): Objective Performance Criteria may be developed to streamline clinical trials for these devices

By reclassification of PMA devices and reducing premarket data requirements, the FDA is attempting to facilitate more efficient and less lengthy US registration processes for manufacturers of affected devices. Obtaining US market access via PMA is typically a complex and expensive effort, so any moves by US regulators to reduce registration burdens for applicants should be welcomed.


  • Stewart Eisenhart