eNews January 19, 2026

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 [email protected], with the subject line “IMDA COVID story.” We’ll compile them and send them back out to you.

Mitchell Kramer

IMDA legal counsel Mitchell A. Kramer died on January 15, 2021. Mitchell was an integral part of IMDA since its founding in 1978 by a group of medical specialty distributors and reps who sought a forum for networking and education.

“Next to his family, his great love was the practice of law,” his daughter, Barbara Kramer, wrote. “He considered representing his clients to be an honor and appreciated the trust that his clients placed in him.” Mitchell was instrumental in developing business arrangements and legal authority to protect commissioned sales representatives and distributors, and he took special pride in his role working with medical device distributors around the country, she added.

After graduating from Yale Law School and serving in Army JAG and the Pennsylvania Attorney General’s office, Mitchell founded his own law firm, which continues as Kramer & Kramer, LLP. His career was bookended by complex antitrust cases involving the plywood and sugar industries, and a recent class action in which he recovered excess payments on behalf of tens of thousands of taxpayers.

“Above all, Mitchell had a strong sense of right and wrong and always believed he should use the law to fight for what is fair,” said Barbara. “I was lucky to have such a father, and privileged to work beside him as his partner.”

And IMDA was lucky to have Mitchell as a true guide for more than 40 years.

We express our sympathy to his wife, Judy, and to Barbara. We will never forget Mitchell imploring us, time after time: “Don’t sign a contract with a manufacturer without having your lawyer look it over first!” “Watch the language on quotas.” “Never leave the words ‘terminate without cause’ standing in any contract you sign!”

A break for breakthrough devices

CMS’s recent rule intended to get breakthrough medical devices to Medicare patients faster drew praise from organizations such as AdvaMed as well as investment firms, reports MedTech Dive. The rule on “Medicare Coverage of Innovative Technology” allows developers of breakthrough devices that voluntarily opt in to receive four years of Medicare coverage. CMS expects manufacturers to use the automatic coverage period to generate the evidence needed to seek formal coverage determinations. J.P. Morgan analysts reportedly identified almost 20 breakthrough devices made by publicly traded companies that could benefit from the rule, including Abbott and Medtronic’s fully implantable left ventricular assist products, Boston Scientific’s single-use duodenoscope, and J&J’s robot-enabled microwave ablation system.

FDA intends to listen to the patient

Empowering patients and consumers to exercise more influence in FDA’s decision-making about new products and therapies is one of the agency’s primary goals for 2021, reports the Regulatory Affairs Professionals Society. The agency expects device manufacturers to give individuals the best information possible – in labeling statements and other marketing claims – to make well-informed decisions about FDA-regulated products. Among the other themes FDA will focus on in 2021: public health emergency preparedness and responsiveness; the power of data (including wearables and artificial intelligence) on FDA’s regulatory work; and the impact of innovation (e.g., individualized therapeutics and precision medicine) on tomorrow’s medical products. Click here to see the FDA’s report.

Top technology hazards

Register here to receive a copy of “ECRI’s Top 10 Health Technology Hazards for 2021,” expected to be released later this month. The 2021 report is said to include topics related to COVID-19, cybersecurity, medical devices, and more. It is intended to help healthcare facilities promote safer health technology use by pinpointing possible sources of danger and identifying action steps that may minimize the occurrence of adverse events.

AI and medical devices

Artificial intelligence/machine learning (AI/ML)-based software is a rapidly progressing field, and the FDA has issued an action plan for introducing AI/ML-based software as a medical device. The plan addresses action the agency intends to take, including fostering a patient-centered approach, including device transparency to users; developing methods to evaluate and improve machine learning algorithms; and advancing real-world performance monitoring pilots. View the action plan here.