insights
The month of March has come and gone in what seems like the blink of an eye! U.S. Senate bills on FDA inspections were filed, regulations were proposed for the medical device industry, and research was conducted on the effects of 3D printing on the pharma and medical device markets. So, in case you missed it, here is a quick recap of what you might have missed in the Medical Device Industry last month.
1. Senate bill aims to streamline FDA inspections process
A bill that was sponsored by Senators Johnny Isakson (R-Ga.) and Michael Bennet (D-Colo.) was filed in the U.S. Senate seeks to streamline FDA inspections of medical device manufacturers by creating a more transparent, risk-based approach. The bill would direct the Health and Human Services Department secretary to “adopt a uniform process and uniform standards applicable to inspections of domestic and foreign device establishments.” Among other processes, the FDA inspection measure would require daily communication from the agency’s inspectors on investigation statuses. The bill is believed to help modernize the FDA inspection process and lead to higher levels of patient safety and more efficient use of inspector time and effort.
2. A fresh lease of life for medical devices?
Considered to be one of the most significant policy shifts of this year, the government in India made a decision to move the medical device industry out of the pharmaceutical sector. According to Finance Minister Arun Jaitley, the new regulations for the medical device industry will be harmonized with international regulations to attract investment into the sector along with reducing the cost of medical devices. The new rules also pursue to evolve a culture of self-compliance by manufacturers of medical devices and the manufacturing licenses for Class A medical devices will be granted without previous audit of the manufacturing site.
3. Research marks 3D printing as vital to pharma and medical device markets
Market analysts have determined that the healthcare industry can benefit from the use of 3D printing technology to help customize medical devices. Resent research conducted by TechVision on 3D printing for healthcare has shown that a great number of markets have shown an interest in implementing 3D printing in a drive towards more personalized medicine. Along with impacting the pharma market, researchers explain that using 3D printing technology for designing and prototyping can also help reduce wastage materials. The research also explains that current products being developed using 3D printing technology are largely in areas like medical implants, prosthetics and surgical guides.
Don’t forget, Kapstone is experienced in drafting and submitting 510(k)’s as well as managing communication with the FDA! Visit our website or Call Us Today to learn more!
