FDA about to exempt fifteen software devices from 510k clearance
A Notice was published in the Federal Register the 15th January 2021, about the exemption of a long list of medical devices from premarket notification. This list, found in table 6 of the Notice, contains 83 class II devices.
Yet, we have to wait for 120 days, to see this Notice published with the list in its final version.
EDIT 2021-04-17: the notice has been withdrawn, and my comments below are just irrelevant gibberish. There's no free lunch.
The main reason of these exemptions is the absence of serious adverse events reported the last 10 years (from 1st November 2010 to 30th November 2020) on these device types.
Amongst these 83 devices, the word "software" appears 15 times. Here is the list:
- Electrocardiograph for OTC use,
- Normalizing Quantitative Electroencephalograph Software,
- Digital Pathology Image Viewing And Management Software,
- Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,
- Radiological Computer-Assisted Triage And Notification Software,
- Radiological Computer Assisted Detection/Diagnosis Software For Fracture,
- Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer,
- Radiological Computer-Assisted Prioritization Software For Lesions,
- X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device,
- Automated Radiological Image Processing Software,
- Source Localization Software For Electroencephalograph Or Magnetoencephalograph,
- Automatic Event Detection Software For Polysomnograph With Electroencephalograph
- Automatic Event Detection Software For Full-Montage Electroencephalograph,
- Burst Suppression Detection Software For Electroencephalograph,
- Infusion Safety Management Software.
Some of them have striking words, like "Detection", "Diagnosis", "Automated", and "Safety".
If we take one example (not chosen at random :-) Radiological Computer Assisted Detection/Diagnosis Software For Fracture, the product code is QBS, and the section in 21 CFR is 892.2090. We're in the Radiology software devices regulated by 892.2050 to 892.2090 sections of the 21 CFR.
We can repeat the same exercise with "Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer", product code QDQ and 892.2090, and so on.
Yet, the PACS viewer, product code LLZ, remains in class II not exempted. There appears a pattern: medical imaging software used for primary diagnosis are not exempted; medical imaging delivering information of secondary importance are exempted.
The first thought that comes to mind is that the FDA is probably overwhelmed by too many 510k submissions on such software of secondary importance (no offense, manufacturers). And this kind of software blossomed with literally dozens to software making use of artificial intelligence to detect patterns in medical images.
Likewise, we have the Infusion Safety Management Software, product code PHC, used to preprogram infusion pumps, and other functions such as alarm transmission. The exemptions go way beyond medical imaging!
These software will never harm anybody, thanks to the fact that:
- The kind of output data is only an aid to ease or speed-up the patient care,
- There is always a medical professional between the computer and the patient, catching erroneous results.
Manufacturers of class II exempt software, enjoy!
On the European side
As long as we have the deadly rule 11 for standalone software, with this wording: Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, there's no chance that software like the ones mentioned above can be placed in class I. Even if they give information of secondary importance, that information is still in the category Inform clinical management, placed in class IIa in the section 11 Annex III of the MDCG 2019-11.
About Infusion Safety Management Software, they "drive or influence" perfusion pumps, and are in the same class.
Yes, manufacturers of standalone software equivalent to the exempted list, your business is still subject to the European regulatory hazard sparked by Rule 11. With this list of 510k exempted devices, the FDA gives you another reason to begin with the US market.