When I ask people about their reaction to the proposed Class II device exemptions published by the U.S. Food & Drug Administration (FDA) on March 14, 2017, I typically receive one of three reactions:
- Yahoo! We are so excited that our [insert medical device] will be exempt!
- I haven’t looked to see if any of the proposed changes might impact our products.
- Huh? What proposed exemptions? Does this mean good news for our organization?
In short, the FDA has proposed a list of Class II devices to be classified as 510(k) exempt – which, regardless of your initial reaction – does equal good news for U.S. medical device manufacturers. (The FDA is currently accepting comments until May 15, 2017.)
Below are some important questions and answers to consider if you find that your Class II device may be exempt from pre-market notification. What might your next steps look like?
Q: What will be the impact to our family of devices if they are determined as exempt?
A: If your organization finds itself in the position of having a product reclassified as 510(k) exempt, moving forward, you will not be required to submit a 510(k) unless you meet the limitations of exemptions. One example of these limitations includes the switch to a different fundamental technology than the predicate device. It is recommended that device organizations check their specific Code for Federal Regulations (CFR) for limitations.
Q: I have a product in development that is on the list; how certain is it that the proposed list of devices will be deemed exempt?
A: Although there are no guarantees of an exemption, product manufacturers may comment to the FDA (by May 15) that they are in agreement that there is a “reasonable assurance of safety and effectiveness” of their product based upon “other regulatory controls, such as current good manufacturing practices.”
Q: Assuming my device is classified as exempt after the review period, what should my organization consider next?
A: An exempt classification would provide significant cost and time efficiencies for some medical device manufacturers through the elimination of the creation, submission, payment (and, waiting!) for a 510(k) clearance. However, the manufacturer is still required to use the product development process and register their establishment and list their device per FDA requirements. Refer to the FDA’s “Medical Device Registration and Listing” requirements here.
Q: My device is not listed, and I strongly believe that it should be reconsidered as an exempt product.
A: Comments to the FDA are strongly encouraged should you believe that your Class II device should be exempt based on “reasonable assurance of safety and effectiveness” based upon “other regulatory controls, such as current good manufacturing practices.”
Q: Are there any surprises in the proposed exemption list?
A: Like any proposed regulatory changes, there are always a few surprises. First and foremost, many of the products that are listed are very low-risk such as furniture, lamps and trays. To think it has taken the FDA this long to list these items on an exemption list is not newsworthy, but interesting.
Additionally, some of the devices that were previously ruled as 510(k) exempt in 2015, were included on the current proposed list. (This may be simply explained as an oversight by the FDA.)
Q: My device is classified with two product codes, but only one is up for 510(k) exemption. What does this mean?
A: Device manufacturers will need to comply with the requirements for all product codes. If one of two product codes requires a 510(k) clearance, your organization will be required to maintain its 510(k) status for that particular product.
Q: I’m unclear as to whether my device may be categorized as 510(k) exempt. How do I ensure I have the right code to confirm our status?
A: It is recommended that you review the proposed Class II device exemptions. This will give you a starting point to determine whether your device is being considered for exemption.
Need Help Navigating the Proposed Class II Exemptions?
The proposed FDA Class II exemptions represent a very real opportunity for some medical device manufacturers to achieve significant time and cost efficiencies throughout their organizations. If you would like to discuss how these changes may impact your overall business objectives, including your regulatory strategy, we encourage you to contact our medical device experts at firstname.lastname@example.org.