Medical Device Firms To Be On Toes For Premarket Submissions


It is worth noting that the US Food and Drug Administration- FDA has recently gone on to highlight the data integrity issues that concern the premarket submissions received in case of medical devices.

The agency has gone on to declare that it has identified a surge in terms of fraudulent as well as unreliable laboratory testing data within such submissions.

It has gone ahead and advised manufacturers, along with the study sponsors, for these products to make sure to carefully gauge the third parties they happen to engage with so as to conduct performance testing and to independently double-check all testing results prior to submitting them to the FDA.

Making sure of the data integrity of medical devices

The FDA went on to stress that these firms are indeed responsible for qualifying third parties that go on to generate data as well as ensuring that all the data that’s submitted to the FDA happens to be truthful as well as accurate.

In recent years, there has indeed been a rising trend in which the entities that happen to contract with the device firms so as to conduct testing on medical devices are going ahead and generating testing data that is either fabricated, duplicated from certain other device submissions, or otherwise unreliable, noted the organization.

Since it takes into account the data integrity of the overall file, the FDA asserted that it is unable to depend on the data so as to grant marketing authorization.

The FDA, as such, highlighted that all the testing data that a firm does not perform itself must be examined, specifically the one that’s relating to biocompatibility as well as other performance testing.

The agency went on to acknowledge that it may be pretty challenging for individual device firms so as to confirm if specific data has been taken from a marketing submission that’s unrelated. But it also expects device firms to take into consideration the testing results that happen to be improbable or impossible on their face or are inconsistent with known data pertaining to the device.

So as to make sure that the medical devices happen to be safe, effective, and high-quality, in its letter, the FDA went on to state that it is taking many actions in order to identify as well as confront data integrity violations.

In its entirety, the FDA asked the medical device sector to be more vigilant as well as proactive when it comes to making sure of the integrity of all data that they go ahead and include in medical device submissions.

Making sure of the safety and efficacy of medical devices

The UK perspective

Medical Devices and IVDs Regulatory Quality and Clinical Consultant, Shweta Agarwal, commented about a recent MedTech Regulatory Reform webinar conducted by the MHRA.

Taking her perspective into account, when considering the future of medical device regulations within the UK, the updates go on to reflect a proactive approach to regulatory reform, thereby prioritizing safety as well as efficacy in terms of medical device development.

Especially it is the MHRA that is taking steps so as to sync with the scope of medical device regulations having international practices, especially the EU medical device regulation- MDR. All this goes on to mean updating definitions in terms of medical devices so as to ensure consistency across borders.

Besides this, Agarwal went on to note positively that the essential needs shall be aligned with general safety as well as performance requirements- GSPRs of the EU MDR, thereby making sure that stringent standards are met.

Finally, the fact is that it is indeed clear that US as well as UK regulators happen to be working so as to streamline guidelines to make sure of the quality and also the safety of medical devices that happen to be made available.