Details:
A paper to compare the regulatory approval process between the EU and the USA for a medical device in the market that has use a new technology.
Medical Device Name: Endoskeleton® TCS System
New Technology: Endoskeleton spinal medical implants utilizes the nanoLOCKTM, which is a new manufacturing process surface technology treatment. The nanoLOCK® surface technology is the only FDA nano-cleared technology for the spine.
Manufacturer: Titan Spine, LLC(www.titanspine.com) is a surface technology company focused on the design and manufacture of interbody fusion devices that participate in the fusion process through nanotechnology.
The main deliverables are:
1. Nanotechnology Description, including some potential risks to patient posed by this technology.
2. General/historical description of other products using this technology in the market.
3. Description of the Titan’s nanoLOCKTM Surface Technology, its advantages vs the traditional technology used in these line of implantable devices. Titan’s website has several papers published about this technology and it also says that Titan Spine nanoLOCK® unleashes the Body’s Own Bone Growth Mechanisms Through Nano-enhanced Interbody Devices and Their Impact on the New Pay for Performance Era.
4. Any known major risks and how it has been or could be mitigated.
5. Description of the Endoskeleton® TCS System implants which includes: (see 510K document included)
a. EU and USA regulatory classification and approval pathway (I will provide the EU since the USA is in the 510K)
b. Description of the users (Ex: patient, physician, surgeon.) and the user‘s environment (Ex: clinic, physicians, home),
c. Intended Use / Indications for Use, contraindications/warning/cautions/risks (if any).
6. EU and USA medical regulatory requirements including:
a. human Factors and Usability requirements,
b. clinical Study requirements,
c. quality and manufacturing requirements,
d. postapproval modification reporting requirements,
e. adverse event reporting requirements, and
f. if there are any recalls of this product in the two countries/regions.