2 min reading time

19 months ago we featured group member Mark DuVal’s Citizen Petition and Petition for Stay of Action with the FDA.

Read that discussion:

The petition challenged FDA’s practices and interpretations for reviewing 510(k)s and asked the Commissioner to stay the implementation of “Draft Guidance: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” It sought reversion to older guidance.

FDA wrote back and said no. Instead, FDA issued new 510(k) guidance as planned. See

In its refusal letter at FDA wrote “your petition for stay of action fails to demonstrate it meets the conditions for FDA to grant the petition.”

Mark writes to his clients:

FDA does not realize and will not accept the serious impact its administration of the 510(k) program has had on innovation and investment in innovation… Its conservative, risk averse interpretations have brought little to no additional safety to devices being cleared or approved. In fact, we believe FDA’s current approach certainly has stifled innovation and failed to bring the benefit of new therapies to the market.

Read the rest at and see some benefit-of-the-doubt conclusions he makes.

Do you share Mark’s viewpoint? Will the new 510(k) stifle your innovations?

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Discussions This Week:

What to do when in trouble finding (good) representation?

Is Misogyny in Medtech an Issue?

How do you estimate the expected life of a device?

I have my Class II prototype. What do I do next?

510k each time I make a change?

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IN CASE YOU MISSED

I’ve been putting the 10x Medical Device Conference presentations online on the http://MedicalDevicesGroup.net blog.

Now available:

• Daniel Kraft’s keynote on Reimagining Health, Medical Devices, and BioMedicine

• Marty Kohn on Big Data Analytics and the Transformation of Healthcare

• Ken Ritterspach on How Medical Device Company SurModics Uses Analytics

• Dave Sheppard on Global Medical Device Channel Management

• Seth Goldenberg on Medical Device Development to International Markets

More to come: http://MedicalDevicesGroup.net

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Video: 8 minutes about Prostrate Cancer Screening