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Regulatory Focus™ > News Articles > FDA Proposes Making it Easier to Classify and Reclassify Medical Devices According to Risk

FDA Proposes Making it Easier to Classify and Reclassify Medical Devices According to Risk

Posted 21 March 2014 | By Alexander Gaffney, RAC

A new regulation proposed today by the US Food and Drug Administration (FDA) would change the procedures by which it classifies and reclassifies medical devices according to their perceived risk, making it much easier for FDA to make changes based on new or changing information.


The proposed regulation was called for by a 2012 law known as the Food and Drug Administration Safety and Innovation Act (FDASIA). Section 608 of the law called for FDA to be given the authority to make classification changes through administrative orders, instead of the extremely lengthy process of proposed regulations it now uses under 21 CFR 860.

That order would still need to involve a device classification panel meeting, but would be published as an administrative order in the Federal Register and subject to a limited comment period-not a proposed regulation subject to a lengthy comment period and extensive governmental review.

As pointed out by FDA Law Blogin 2012, existing regulatory pathways for reclassifying devices "have proven so cumbersome that they are rarely used."

"If FDA takes advantage of this new authority to accomplish the same objective by administrative order, there is great potential to improve the efficiency of FDA's regulatory processes," they added.

Proposed Process

Now FDA is out with its proposed regulation intended to carry out Section 608 of FDASIA.

"The level of regulation necessary to provide such assurance should be closely tailored to the risk presented by a type of device," FDA states in its 21 March 2014 Federal Register notice announcing the proposed rule.

The proposed rule focuses much of its energy on regulatory definitions, which determine which category a device should be classified into. Class I devices are low-risk devices; Class II are moderate-risk; and Class III represents the highest category of risk. High-risk devices are understood by FDA to be those which are intended to support or sustain human life, pose an "unreasonable" risk of illness or injury, or are otherwise substantially important to preventing an "impairment of health."

Under the regulation, FDA said it would "identify those potentially high risk devices for which insufficient information exists to determine that special and general controls would provide reasonable assurances of safety and efficacy (RASE)."

Five categories of high-risk, Class III devices would thus be established:

  1. devices that present known risks that cannot be controlled
  2. devices for which the risk-benefit profile is unknown or unfavorable
  3. devices for which a full review of manufacturing information is necessary.
  4. devices for which premarket review of any change affecting safety or effectiveness is necessary
  5. combination products

Other portions of the guidance focus on "generic type" devices and their product codes, or procodes for short. Under the new regulation, FDA would be able to group certain procodes together, allowing for a single risk classification to cover multiple types of similar devices.

Comments on the extensive proposed regulation are due to FDA within 90 days.


Medical Device Classification Procedures

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