Citing the increasing number of cyber attacks in healthcare and concern about the potential for targeting medical devices, the FDA announced in an October 1, 2018 press release the publication of its Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook.
The National Sanitation Foundation (NSF) has produced a series of online training courses for regulatory compliance officers and auditors involved with regulatory processes working in the medical device industry in the five countries participating in Medical Device Single Audit Program (MDSAP).
A new study has found the excise tax on medical devices enacted as part of the Affordable Care Act had a $665 million impact on the medical device industry, according to an Iowa State University researcher.
In an update to its review of the International Medical Device Regulators Forum report the FDA in December reconfirmed that it will continue to accept results of the Medical Device Single Audit Program (MDSAP) for medical device regulatory approval.
Did Republicans forget the medical device tax?
When all the dust had settled following the passing of the Tax Cut and Jobs Act, the $1.5 trillion Republican tax overhaul, the medical device industry was left scratching its collective head and asking what happened to the medical device excise tax repeal?
The FDA issued its final guidance for medical device interoperability on Sept. 6, 2017. The guidance offers insight into what the agency is looking for in terms of safety and effectiveness for medical devices that are connected to each other and to other technology.
The topic of cybersecurity for medical devices became a hotter issue this past year amid several high-profile hospital cybersecurity breaches, and the FDA is paying close attention.
In a blog post on the FDA’s site, Suzanne B. Schwartz, the FDA’s Associate Director for Science and Strategic Partnerships at the Center for Devices and Radiological Health, she outlined the FDA’s approach to medical device cyber safety.
Stormram 4 sounds like the latest video game from Xbox, instead it is a unique robot made from 3D printed plastic that may provide an unprecedented level of accuracy in doing breast cancer biopsies.
FDA exempts more than 1000 devices from 510(k) premarket submissions.
The month of April was another busy one, especially in the Medical Device industry! April was jam packed with news about the latest outlook of the medical design and manufacturing fields, the advancements of 3D printing technology in surgical training, and the key risks in product development. So, in case you missed it, here are a few highlights of medical device news from April.
The month of March has come and gone in what seems like the blink of an eye! U.S. Senate bills on FDA inspections were filed, regulations were proposed for the medical device industry, and research was conducted on the effects of 3D printing on the pharma and medical device markets. So, in case you missed it, here is a quick recap of what you might have missed in the Medical Device Industry last month.
Will 2017 be a good year for MedTech in the US Healthcare Industry? Signs point to yes.
Looking at the uncertain healthcare landscape under the new Trump administration, predicting future healthcare markets seems like an exercise in magic 8-ball prediction. You know the toy that answers any yes or no question with some ambiguous answer like, “Luck is on your side.”
Bloomberg reported that in a conference call, AstraZeneca Plc CEO Pascal Soriot pointing to the daily uncertainty over repeal and replacement of the ACA, financing care, and in rule setting for everything from how hospitals operate to which drugs can be sold said, “You really cannot predict the unpredictable.”