Please visit at AACC 2019 August 6-8 at the Anaheim Convention Center. Its a great time to revisit older relationships and to make new ones! We hope you will come by for a visit and of course if you are unfamiliar with Omnica, please come by to learn about our 35 year history of designing laboratory instruments.
I wanted to thank you all for your continued support of this newsletter. I hope that it continues to be of value to you and your comments are always welcome. I would also like to announce that I have officially left Paramit Corporation after 3.5 years. I have enjoyed my time there and am still amazed by the tremendous manufacturing systems they have put in place that makes them unique in the industry.
I have accepted a position with Omnica Corporation based in Irvine. Omnica has built an amazing reputation over the past 34 years and they have equipment and capabilities that are unmatched by others in the industry. I will be managing Sales and Marketing efforts for the company.
You will still be able to find me at many of the local networking events and trade shows so not much will change outwardly. I am still dedicated to helping companies find the best solutions for them. I am also managing the In vitro Diagnostic (IVD) LinkedIn group so please look for new activity happening there.
Thanks to Paramit for their support and I am excited to see what we can do to grow Omnica further. Please check us out at http://www.omnica.com
Let me know your comments!
Passive Component Shortages:
As some of you certainly know, there has been a large demand increase and manufacturing constraints on passive electronic components. There are severe allocation measures being taken across the industry. Prices are trending up and lead times have been extended dramatically.
The reality is that constraints on these inexpensive components can hold up the entire build of a system and you do not want that to happen! Therefore we suggest placing blanket orders as soon as possible on these items to get in the que.
Some data on the primary suppliers is provided in the document below.
The FDA has released new guidance for comment regarding Multiple Function Devices (like Cell phones) I often get asked about how things like software are regulated in digital health. Here are some nuts and bolts! Enjoy!
Today, the FDA issued a draft guidance related to Digital Health and the 21st Century Cures Act aimed at clarifying the FDA’s policy for products with multiple functions that include at least one device function. Starting tomorrow, you can submit your comments to the docket by June 26, 2018.
The FDA does not regulate certain software functions that do not meet the statutory device definition if they are contained in a multiple function product. However, the FDA may assess the impact of the software function on the safety and effectiveness of the device under FDA’s premarket review.
The draft guidance, “Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration Staff” proposes that when assessing a multiple function device product, manufacturers and the FDA should determine if any other function may impact the safety or effectiveness of the device function under FDA’s premarket review. If so, the impact should be evaluated to determine whether the other function has a positive or negative impact on the device function in their premarket submission. The guidance details what should be included in the premarket submission of a multiple function product, if the other function could adversely impact the device function under FDA’s premarket review.
The FDA recommends that when possible, the device function under FDA’s premarket review should be separated from other functions of the device, and that the higher the degree of separation, the easier it is for the agency to independently review it for safety and effectiveness.
Issuing guidance to provide clarity for manufacturers, FDA staff, and other stakeholders on the medical software provisions of the 21st Century Cures Act is part of the FDA’s long-term Digital Health Innovation Action Plan.
If you have questions about how the 21st Century Cures Act affects your products, or if you have comments on how the FDA should regulate medical software, please email firstname.lastname@example.org.
Upcoming User Session: On Thursday, May 10, 2018, the FDA will host an interactive session to discuss progress the agency has made on the Software Precertification Pilot Program. Webcast is available and no registration is required.