In recent past regulatory body: FDA has brought in many structural changes which are either add-on to current guidelines or modifications of existing ones.Some of the key activities of FDA in last couple of months include:
Some of the recent developments at regulatory front which ranges from introduction of novel process and devices to FDA scrutiny to therapeutic areas taking a lead in field of approval.
Medical Device Industry has various gateways that an individual device has to pass through to reach commercialization phase. One of the most important gateway being regulatory.
1. Inclusion of novel gateways for speedy device approvals
2. Heath care mobile app approvals
On the account of increased user fee paid by medical device industry to FDA, FDA has increased the labor force to fasten their current laggard approval process. These new amendments have certain expectations from device OEMs, which include devices’ innovation and standpoint in comparison to their counterparts. Speedy approval process is practice picked from sister pharma industry where the similar process has seen significant penteration for certain oncology drugs.Some of the other add ons that medical device regulatory bodies have asked OEMs to embrace include: UDI, which stands for Unique device identification, a regulation and compliance targeted towards tracing any safety related issues across value chain.
All the hard work and changes are aimed towards avoiding false start situations or instances where medtech start-up has to reinvent the wheel. As authorities await for public comments across multiple facets of device approval process here is quick info-graphics on approved product types: