Comments on: When will the FDA drop the gavel?

By: Frank Poggio

Frank Poggio — Wed, 17 Nov 2010 22:56:11 +0000

While the FDA is still thinking about medical software, ONCHIT, the Office of the National Coordinator for Health Information Technology is moving ahead. ONCHIT was created by CMS as part of the ARRA HiTECH Act of last year. Smart medical devices that add /change /delete PHI or clinical data will have to get ONCHIT certified or you will not be able to sell them to any health facility. On a purely regulatory basis your software does not have to be ceritfied, but from a marketing and sales perspecitive it will be. Hospitals and physician offices will not be eligible for Meaningful Use bonuses, or will be subject to MU penalties if they do not run certified systems…or their certified systems tie into non-certified systems.
More info at: http://www.kelzongroup.com/ONCHIT.html

By: David Albert, MD

David Albert, MD — Fri, 20 Nov 2009 20:50:48 +0000

Big difference between these two recommendations. The mammography recommendation was NOT DONE BY CLINICIANS while the PAP smear rec was done by ACOG– the docs who care for cervical cancer. Another thought that clearly impacted this decision is that the HPV vaccine will continue to have increased penetration in younger women who are not sexually active (or maybe are) and they will be at a significantly lower risk of cervical cancer anyway. Clearly , clinical decisions should be made by clinicians using the best data provided by research but not made by statisticians looking at that same data– they have no accountability vis a vis the patient.

By: On the heels of controversial mammography recommendations, new cervical cancer screening guidelines – MedCity Morning Read, Nov. 20, 2009 : MedCity News

Fri, 20 Nov 2009 12:43:29 +0000

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By: David Albert, MD

David Albert, MD — Thu, 19 Nov 2009 15:58:27 +0000

The FDA is in the beginning of a major review of the entire 510(k) process so if you are looking for quick action–forget it. The FDA has domain over medical products and has classifications: Class 1 like bp devices bought at CVS, Class 2 like ECG machines in hospitals and Class3 like pacemakers. Many wireless health devices will be Class 2. I believe Cardionet and other wireless cardiac monitoring products are considered Class 2. The Airstrip OB application is part of a system which includes the interface to the fetal monitoring data (via a maternal-fetal Clinical Information System which has already been FDA’d which interfaces to the fetal monitor which has been FDA’d), the “server” and the application. Airstrip had to show data integrity (it is allowable to show no data but not bad data). Over 12 years ago, I received a 510(k) for a product that was an ecg monitoring device that used a PDA. Those precedents have been set. People should stop griping and get to work understanding things like GMPs, clinical validation, IRBs, and the 510(k) process.