Market Pathways Top 5 April 2022

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ARTICLE SUMMARY:

The top five Market Pathways articles posted in April to MyStrategist.com, chosen by readers and editors, include our Document Depot database of global policy documents, proposed 510(k) user fee hikes, devices with a chance of getting Medicare add-on payments, Germany and France push to delay MDR, and FDA updates cybersecurity guidance.

The top five Market Pathways March articles.

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#1: Pathways Document Depot: Cataloging Medtech Policy

A specification document on the quality management of clinical trials in China, a technology assessment from UK NICE for a COPD management app, and technical revisions to the EU’s guide on "summary of safety and clinical performance" (SSCP) requirements are among items captured recently in Pathways’ Document Depot.

#2: 510(k) User Fee Rate Slated to Jump 50% Next Fiscal Year

510(k) submissions will be notably more expensive next year under a recently hatched MDUFA V user fee agreement. The 510(k) user fee rate will increase by a 50% margin in FY 2023 compared to the current rate, and then step up more gradually over the next five years, according to Market Pathways’ review of draft legislative language. The PMA fee rate will go up by about 13% next year.

#3: Devices With a Shot at New Inpatient Add-On Payments

But so far only one device, a vagus nerve stimulator for stroke patients, is a shoo-in to get a new Medicare hospital inpatient new technology add-on payment (NTAP) next year. Other products will qualify for the bonus if they can win FDA authorization in time or meet other CMS thresholds.

#4: Germany and France Push to Move MDR Deadlines

Recognizing the delays that are likely to emerge from a system ill-equipped to implement the new Medical Device Regulation in Europe, groups representing the two largest EU medtech markets are urging that the current timelines be pushed back to prevent impending bottlenecks.

#5: FDA Proposes Tougher Cybersecurity Rules

With global risk on the rise, FDA has issued its much-anticipated draft device cybersecurity guidance. Medtech cyber czar Kevin Fu explains that this proposal takes a total product lifecycle approach, incorporating both pre- and postmarket coverage, while emphasizing the need for companies to employ threat modeling as part of device development. One change: The focus is now on software with hardware seen as less of a threat.

 

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