Last week the US FDA announced a new web page setting out its current Small Business Program. This program provides fee breaks for small businesses seeking FDA regulatory approvals. The fee breaks are substantial (up to 75% off) and a business doesn’t have to be all that small to qualify. Non US businesses can apply too.
Businesses wishing to market Class II Medical devices (or certain Class I and III) or IVDs in the USA are required to obtain premarket clearance through the 510(k) notification process.
When you’re considering the US market for your product, you may have spent hours browsing through the internet, reading through mountains of regulations, guidance documents and standards, researched published white papers and yet… you’ve not been able to answer one fundamental question, “Do you have the right 510(k) strategy?”
We get excited by our clients successes, especially with truly breakthrough innovations. We are delighted to congratulate the team at LBT Innovations in achieving US FDA clearance for their revolutionary APAS technology.
The US FDA has issued a draft guidance to update and clarify the 510(k) submission decision-making process for manufacturers whose devices have been modified. The guidance follows the controversial 2011 draft, which was withdrawn after Congressional Intervention.
FDA has published a detailed draft guidance on regulation of 3D printed devices. Offering detailed advice on both design and manufacturing and on device testing, the guidance exposes the agencies “initial thinking” on regulatory controls for 3D printed devices. What is a “Leap Frog Guidance anyway? Read on…
Regulators the World over have been toughening up on the requirements for clinical evidence of safety and performance of medical devices. More devices are required to have direct clinical trial data, and where literature based evidence is accepted, the standards are getting tougher. China’s CFDA strengthened clinical evidence requirements as it revamped regulations over the past two years and Australia’s TGA currently has a new Clinical Evidence guidance out for consultation. We take a look, the international similarities are striking.