As originally asked by Chanderkanth Gautam.

Growing number of recalls in medical devices , and FDAs pressure to adopt PMA pathway for different version of innovative devices is picking up. Will this offer a solution to device OEMs hurdles or a different approach is required to tackle these problems?

PIERRE BITOUN
President & CSO at i Sonic Medical
Thanks for all the input, Robert this is a key discussion for many of us, for example for a device considered by the FDA to be a low risk device for which there is a predicate device, the fact you use a new technology must make you consider if there are new risks not previously associated with the predicate device and that is a tough question to answer sometimes. In the strict academic sense if you use a new technology the risk profile of the device becomes different and this should drive you away from the 510k route to PMA, yet does this come really into discussion when the device is considered low risk by the FDA anyway?? or this distinction applying more to the high risk or medium risk devices?…

Rob Packard
510(k), CE Marking & Quality System Consultant
It used to be that conducting a Clinical Study for a product that is eligible for a 510(k) was extremely rare. Now clinical studies are becoming more common and 10-15% of 510(k) submissions include clinical study data. However, the regulatory pathway can be determined for almost any product without conducting a clinical study. The type of IDE really doesn’t directly impact the determination of whether a product is going to require a 510(k) or a PMA. For a low or medium risk device, the IDE just gives the company an opportunity to start a study before 510(k) clearance is received.

Matthew Smith
Vice President of Global Sales
Robert, Please correct me if I am wrong. My understanding is that there is a two step process (in simple terms). First question is Significant Risk or Non-Significant Risk. That will determine abbreviated IDE or IDE. Once you take that path then the next question is 510K or PMA. Now, it could be that all significant risks must go PMA. However if you go the non-significant risk route, you still have to answer the next question which is equivalence to predicate. That answer determines PMA or 510K. At least this is my understanding…

Chanderkanth Gautam, CPSM
Team Lead | Procurement Strategy and Analytics
Thank you so much for sharing that link, it was really helpful.

Rob Packard
510(k), CE Marking & Quality System Consultant
Thank you for the update on AED’s Kenneth. The classification database still reflects the 510(k) requirement, but I was able to find an order in March regarding this change: [http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM345286.pdf|leo://plh/http%3A*3*3www%2Efda%2Egov*3downloads*3NewsEvents*3Newsroom*3MediaTranscripts*3UCM345286%2Epdf/R_Vw?_t=tracking_disc]. This is a very new development.

Kenneth Olson
Medical Technology Professional
The FDA recently changed is guidance regarding AEDs. As Class III devices, AEDs are now required to go through the PMA process. Historically, they have been allowed to utilize the 510(k) process, since they are pre-amendment devices. There are roughly 26 devices that fit in this category, being Class III, but utilizing the 510(k) clearance route. The FDA has been reviewing them and either reclassifying to Class II, or requiring a PMA. In the case of the AED, they have decided to require a PMA, primarily due to the number of recalls and adverse events associated with AEDs.

Chanderkanth Gautam, CPSM
Team Lead | Procurement Strategy and Analytics
Thank you so much for your response. To surmise the discussion and to validate my understanding, devices undergo 510k or PMA pathway on the account of the risk associated with individual device and not availability of predicate versions of them. All Class III devices irrespective of their earlier version needs PMA pathway with exceptions to AED alone.
Class I device No regulatory pathway
Class II device 510k pathway: sometimes might require clinical trial-Equivalence to predicate devices
Class III devices PMA pathway: requires clinical trial

Rob Packard
510(k), CE Marking & Quality System Consultant
The PMA regulatory pathway is intended for high-risk devices, and some of those devices have predicates that also have PMAs. If a device does not have a predicate, and the device is low- or moderate risk, then the DeNovo process is a better option than a PMA. It used to be that companies had to submit a 510(k), and only after the 510(k) was rejected could they apply or the DeNovo route. Now they are allowed to skip immediately to the DeNovo route. If a device is a PMA initially, the second and third generation products (as well as competitor products) will also require PMA submissions. Once a device requires a PMA, the only way to eliminate the requirement for a PMA is to have the device reclassified. That is a very slow process, and all the companies that already have the PMA will fight you. All three examples you provided (i.e. – insulin pump, AED, and glucose monitoring device) are all 510(k) devices. Insulin infusion pumps are Class 2 with a special controls guidance document, AED’s are a rare Class 3 device that requires a 510(k) rather than a PMA, and glucose testing systems are an IVD product that is Class 2 with a special controls document. I believe that insulin pumps may have been a drug submission initially, the AED’s may have been allowed to go through the 510(k) route only after a safe track record was established, and glucose monitoring systems pre-date 510(k) regulations.

My personal opinion is that the risks associated with devices of emerging concern and recalls should be risk-controlled by mandating post-market surveillance or post-market clinical follow-up. This could be semi-annual reporting for the first two years of a new product and annual reporting after two years.

Chanderkanth Gautam, CPSM
Team Lead | Procurement Strategy and Analytics
Hey Robert,
Thank you so much for your response. I understand that 510K pathway is only for devices which have predicate versions while PMA is for novel devices. Novel devices which do not have predicate versions to prove equivalence with. But my query is if a device OEMs is launching next version of insulin pump,AED,Glucose Monitoring devices, all of them being class III devices, Ideally since they have predicate version to prove their equivalence they should go through 510K. Rite? Under the light of recent events , which includes these devices facing recalls, don’t you think that PMA pathway might be applied for devices already having predicate devices or special 510k pathway requiring clinical trial data might catch up.

Rob Packard
510(k), CE Marking & Quality System Consultant
The 510(k) process is intended for devices that are equivalent to existing devices that are already on the market and have known risks. A PMA process is intended for novel devices that have no similar devices on the market. The cost difference between the two pathways is about 100x. The reason for the growing number of recalls is not related to the regulatory approval pathway, and FDA is not likely to adopt a PMA pathway instead of the 510(k) pathway.