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Home » regulatory

Articles Tagged with ''regulatory''

U.S. Capitol building, Washington D.C.

FDA user fee legislation passes first hurdle in House of Representatives

May 11, 2022
By Mark McCarty
The legislation that would renew a number of FDA user fee programs, the Food and Drug Amendments Act (FDA Act) of 2022, has passed the first legislative hurdle in a subcommittee of the U.S. House of Representatives, but there are several issues with the bill. According to members of the subcommittee, the issues include an absence of provisions for medical device servicing, and the absence of legislation for FDA regulation of lab-developed tests (LDTs), issues that are unlikely to be resolved before the legislation is passed out of the House.
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Green traffic light

Neuronetics wins FDA nod for Neurostar TMS for OCD

May 11, 2022
By Meg Bryant
The FDA has greenlighted Neuronetics Inc.’s Neurostar transcranial magnetic stimulation (TMS) system as an adjunct treatment for adults with obsessive-compulsive disorder (OCD). The noninvasive treatment, which uses repetitive, focused magnetic pulses to stimulate brain cells, is already cleared and marketed in the U.S., Japan and select other countries for major depressive disorder (MDD).
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2022 MedCon

Cybersecurity expertise still in short supply, but solution nowhere in sight

May 9, 2022
By Mark McCarty
Cybersecurity remains a pressing issue for medical technology, in part because there are new, small companies jumping into this space seemingly every day. However, there is a shortage of talent in cybersecurity, something that Dan Lyon, director of cybersecurity at Boston Scientific Corp., of Marlborough, Mass., said will not ease soon due to a lack of interest among colleges and universities in providing curriculum and degrees in this area.
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FDA announces investigation into Fresenius hemodialysis units

May 9, 2022
By Mark McCarty
The U.S. FDA reported it is evaluating the potential for exposure to some chemicals associated with the use of several models of hemodialysis machines made by Fresenius Medical Care Inc., of Waltham, Mass., including units that are no longer in production.
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Barostimneo CVRx

Cvrx granted conditional labeling approval for MRI with implanted neurostimulator

May 9, 2022
By Annette Boyle
Cvrx Inc. secured U.S. FDA approval for magnetic resonance-conditional labeling for its Barostim system, a neuromodulator that improves symptoms of patients with heart failure. With the latest approval, patients with the implanted system can have magnetic resonance imaging (MRI) at 1.5T under the specified conditions.
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Lumipulse-G

FDA grants Fujirebio first marketing authorization for in vitro diagnostic for Alzheimer’s

May 5, 2022
By Annette Boyle
Mark it as a day to remember. The U.S. FDA has awarded de novo marketing authorization for the first in vitro diagnostic (IVD) test for Alzheimer’s disease (AD), enabling diagnosis of the dreaded disease years earlier than current clinical tests. Fujirebio Diagnostics Inc.’s Lumipulse G β-Amyloid Ratio (1-42/1-40) measures specific proteins in cerebral spinal fluid to provide rapid assessment of the risk of amyloid plaques, an indicator of the disease that may develop decades before cognitive impairment occurs.
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EU flag, map, charts
Medtech Forum

Medtech leaders call for innovation friendly environment in Europe

May 5, 2022
By Catherine Longworth
When it comes to innovation, Europe has a thing or two it can learn from the U.S. according to European leaders. Speaking at the Medtech Forum meeting in Barcelona, Medtech Europe CEO Serge Bernasconi said Europe’s focus on safety issues is stifling innovation across the continent.
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Woman scanning test tubes in the lab
Medtech Forum

Industry urges authority action as IVDR date approaches

May 5, 2022
By Catherine Longworth
As the implementation date of In Vitro Diagnostic Regulation (IVDR) looms on May 26, 2022, significant uncertainty remains around the new regulatory system. Under Directive 98/79/EC around 10% of all IVDs placed on the market need notified body involvement, whereas under the IVDR this will rise to 80%-90%. Notified body shortages continue to be a major challenge for industry, with many manufacturers yet to receive certification. The situation is expected to be particularly problematic for SME manufacturers who will see most of their products blocked on the market if they don’t receive validation in time.
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U.S. Capitol building, Washington D.C.

House user fee bill omits action on lab-developed tests, SaMD

May 5, 2022
By Mark McCarty
The legislation that would reauthorize the U.S. FDA’s user fee programs is now in the works in the House of Representatives, but the legislation is fairly lean when considering the number of issues facing the agency.
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2022 MedCon

FDA’s software pre-cert program to advance only incrementally

May 5, 2022
By Mark McCarty
The U.S. FDA’s pre-certification (pre-cert) program for software as a medical device (SaMD) seemed to run out of steam before the COVID-19 pandemic arrived, but the FDA was always presumed to need help from Congress to roll out a permanent version. A session at this year’s MedCon suggests that there is still life left in the pilot version of the SaMD pre-cert program, a critical development given that the legislation for the device user fee program offers the FDA no new statutory authority for a novel software regulatory framework.
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