Does iPhone for photographic services need FDA approval

Mon, 16 Mar 2015 14:57:28 GMT

Everyone,

I received another inquiry I am hoping you can assist me with.

Much appreciate your help! Best regards,
alanhome@aol.com>

Please post responses here or feel free to respond directly to 'Alan's emial.

Thanks,

Barb McCalley

Mon, 10 Aug 2015 16:52:37 GMT

While I'm no Doctor, or Lawyer, my understanding has been that if something is used for medical diagnostics it must be approved by the FDA, particularly if the government is the source of health insurance (medicare/medicaid). The monkey wrench in that thought: Avastin.

The only thing on the FDA website that I could readily find was this PDF regarding the process of a glaucoma imaging device becoming FDA approved.

http://www.fda.gov/downloads/medicaldevices/newsevents/workshopsconferences/ucm326755.pdf

Mon, 10 Aug 2015 17:11:44 GMT

Another search found two helpful links via Emergo.

The process for a medical device to become FDA approved is the US FDA 510(k) process. That process is briefly detailed here:

http://www.emergogroup.com/resources/articles/fda-510k-clearance-process

The list of medical devices which are 510(k) excempt are here:

http://www.emergogroup.com/resources/articles/fda-510k-exempt

Mon, 10 Aug 2015 17:13:45 GMT

There's a link on that last page from Emergo which is broken, the current site for finding approved and pending-approval for medical devices is here:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/default.htm

It doesn't directly answer the question, but if these other devices doing the same thing require FDA approval that's probably a good sign that the next device will need it too.