Recently the FDA posted two draft guidance documents that outline FDA current thinking about low-risk devices intended to promote general wellness and the risk classification approach to medical device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 I previously wrote about the general wellness draft guidance. This blog analyses the FDA medical device accessory draft guidance.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The medical device accessory draft guidance clarifies FDA’s policy regarding the classification of accessories and encourages use of the de novo classification process.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 draft 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.
As with any other drafts, the FDA seeks input on these draft guidance documents from industry and other stakeholders during the comment period. I am interested in hearing from readers whether you think these guidances will have a positive impact on your business.
Vesna Janic is a Director of Quality/Regulatory at StarFish Medical. Her expertise in regulatory compliance and conformance with standards guides our QA/RA team and helps clients avoid waste while gaining time to market.