StarFish analysis: Medical device accessory draft guidance

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StarFish analysis: Medical device accessory final guidance

Authors: Vesna Janic

The FDA posted two guidance documents that outline FDA current thinking about low-risk devices intended to promote general wellness and the risk classification approach to medical device accessories. I previously wrote about the general wellness guidance.  This blog analyses the FDA December 2017 medical device accessory final guidance.  In both cases, less regulatory burden will make huge impact on the ability of low risk devices inventors to bring products to market faster and cheaper.

The medical device accessory draft guidance clarifies FDA’s policy regarding the classification of accessories and encourages use of the de novo classification process.

The guidance reminds us that under current regulation the term ‘device’ includes ‘accessory’, therefore the classification of accessories was determined in two ways:

  • Same classification as parent device via 510(K) clearance or Premarket Approval Application (PMA) approval
  • Separate classification regulation or order for the accessory (usually for accessories that may be used with multiple parent devices)

The main message of the guidance is that because some accessories have a lower risk than their parent device, they can be placed in  lower class. The FDA example is an accessory for a Class III parent device.  This accessory may pose lower risk that could be mitigated through general controls, or general and special controls, and could be regulated as Class I or Class II.   As a result, the FDA encourages manufacturers to utilize the de novo classification process and request risk based classification for accessories that do not have a legally marketed predicate.

I am interested in hearing from readers whether you think these guidances have made a positive impact on your business.

Vesna Janic is a former Director of Quality/Regulatory at StarFish Medical. Her expertise in regulatory compliance and conformance with standards guided our QA/RA team and helped clients avoid waste while gaining time to market.

Images: StarFish Medical