Patti Shragher, Senior Account Manager, Life Sciences
Reed Tech Life Sciences representative Patti Shragher attended The Vision Expo West 2022 conference, on September 14th – 17th. This year’s event took place at the Venetian Convention Center & Expo in Las Vegas, Nevada. We asked a few questions about her experience.
Reed Tech Life Sciences (RT LS): “What was your favorite part of the conference?”
Patti Shragher: “My favorite part of the conference was learning about the various members, their go-to-market approach, meeting newly acquired customers, and spending time with prospects. I was excited to represent Reed Tech for eyewear industry UDI solutions.”
RT LS: “What themes did you notice? What problems are manufacturers facing related to Unique Device Identification (UDI)?”
Patti: “The Vision Council leadership educates their members VERY WELL on all regulatory topics that may affect them. In fact, there are members on The Vision Council board, and that demonstrates how much they value their members’ input. Attendees were very aware of government relations and tariffs. Most import their products from China and the tariffs are making it expensive; many have looked for other areas to manufacture and have experienced rail strikes you name it. They pay exceptionally good attention to anything and everything affecting their business.”
“Reed Tech can help by being present at their conferences, demonstrating our true commitment as a UDI data submissions provider to The Vision Council and to its members. My impression was that members very much appreciated our presence, demonstrating again that we are making a commitment to The Vision Council and its members.”
RT LS: “What did you learn that surprised you?”
Patti: “The very ‘high-end’ members have a different sales approach than the majority of the other companies in attendance. They have suites and product showings that are by appointment only.
RT LS: “How familiar were the manufacturers with The Vision Council Response to the FDA guidelines for UDI data submissions related to the eyewear industry?”
Patti: “I would say that ~65% of the members were familiar with “UDI” due to three factors”:
1. Reed Tech UDI Webinars (free to members and also available on demand)
2. Strong messaging by The Vision Council leadership to its members
3. Consistent outreach by the Reed Tech Sales team
If you are not familiar with the Final Guidance issued by the FDA and The Vision Council response, here are key takeaways:
On Friday, July 22, 2022, the US Food and Drug Administration (FDA) issued its Final Guidance on GUDID exceptions for Class I ‘consumer health products.’ For the eyewear industry, most of the impact fell on Plano sunglasses and OTC readers. These products must fully comply with UDI labeling as of September 24th, 2022 and GUDID reporting as of December 8th, 2022.
The Vision Council Response:
The FDA guidance issued on July 22 prompted a swift response from leadership at The Vision Council.
There are four key takeaways for manufacturers of eyewear that emerge from the guidance document. These include:
1. Plano sunglasses and OTC readers must fully comply with UDI labeling and GUDID reporting
By the FDA’s regulations, any medical device subject to impact resistance testing is a “restricted device.” Thus, all eyewear devices with lenses that are required to pass the drop ball test are considered restricted devices by the FDA. This means that Plano sunglasses and OTC readers are not ‘consumer health products’ and will need to comply 100% with UDI – labeling (using UPC codes if you so choose) AND GUDID reporting.
2. It is our reading of the document that spectacle frames meet the definition of “consumer health products” and are exempt from UDI GUDID reporting
Because spectacle frames do not have lenses that require impact resistance testing, they are not “restricted devices.” As such, they are exempt from GUDID reporting per the guidance document as consumer health products.
3. New compliance date is Dec. 8, 2022, for GUDID reporting
The FDA extended the compliance date for GUDID reporting of all Class I devices by 75 days, moving the compliance deadline from September 24 to December 8, 2022. However, the requirement that all Class I devices have a UDI (which can be a UPC) is still scheduled for September 24, 2022.
The Vision Council has recommended Reed Tech, offering members access to a full-service solution to manage UDI submissions to US FDA and other Health Authorities.
How Reed Tech can help
Reed Tech is a leading FDA supplier of Unique Device Identification (UDI) information, submitting close to one-quarter of all NLM Access GUDID UDI records annually, representing about 34% of electronic SPL submissions to GUDID.
With SingleSource™ for Medical Devices, UDI data is managed throughout the product lifecycle in a compliant SaaS environment and includes scalability for additional volume and global health authorities. Reed Tech has active UDI channels for US FDA, China NMPA, South Korea MFDS and staging for EU EUDAMED.
If you have questions about medical device Class I or are interested in how Reed Tech can help you with regulatory compliance, please contact the Reed Tech Life Sciences Team at [email protected]