eNews January 12, 2021

The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association

How is COVID-19 affecting your business, your people, your customers? IMDA is a membership organization, and in times like these, we can all use some camaraderie. If you have a COVID story to share, advice to offer, or a warning to sound, send it to Mark Thill, IMDA’s communications director, at mdthill1913@gmail.com, with the subject line “IMDA COVID story.” We’ll compile them and send them back out to you.

FDA: Safer technologies go to head of the line

The Safer Technologies Program, or STeP, is FDA’s new, voluntary program for medical devices and device-led combination products that are expected to significantly improve the safety of currently available treatments or diagnostics for non-life-threatening or reasonably reversible conditions. Devices are eligible for the program if they are subject to review under a premarket approval application (PMA), De Novo classification request or premarket notification (510(k)). FDA says STeP will help patients have more timely access to these devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance.

Manufacturers’ user fees for 2021

Small manufacturers of medical devices will pay the FDA $3,108 to submit a 510(k) premarket notification, while large manufacturers will pay $12,432, reports the Regulatory Affairs Professionals Society. Premarket applications (PMAs) will cost $91,414 for small businesses and $365,657 for large ones. A small business is defined as a business, including its affiliates, whose gross receipts and sales are less than $100 million for the most recent tax year.

Do-it-yourself X-rays

Researchers in Finland are developing a portable X-ray machine for examining bones in the palm and ankle, according to New Atlas. The tabletop unit would incorporate built-in radiation shielding, meaning it wouldn’t have to be kept in a lead-lined room. A video screen guides patients through the process, showing them how and where to place the injured appendage. It then automatically takes the X-rays and tells the user if a break is detected. The idea is that the machines could be set up at locations such as ski resorts or medical clinics, where patients could self-check their injuries to see if a bone was indeed broken.

Plan on it

The pandemic will end. We’re pretty sure. And when it does, plan on attending the IMDA/HIRA Annual Conference, June 21-23, 2021, at Eaglewood Resort in Itasca, Illinois — just a few miles from O’Hare International Airport in Chicago. What are you interested in learning? Let the conference committee know by emailing IMDA Executive Assistant Katie Sizemore at imda@imda.org.