June 20, 2022
The FDA has expanded its activities regarding ethylene oxide (EtO) as a device sterilant with the announcement of a new pilot program for existing 510(k) regulatory filings. This new program would...
May 16, 2022
The House of Representatives is processing legislation to renew the FDA’s user fee programs, a bill that includes a number of key provisions for drug and device makers alike. The bill is likely to be...
April 28, 2022
Negotiations between FDA and industry regarding the reauthorization of the Medical Device User Fee Amendments (MDUFA V) are complete and the final commitment letter summarizing the deal is expected to...
April 27, 2022
The Advanced Medical Technology Association (AdvaMed) is the largest medical technology association, representing life sciences device, diagnostics, and digital technology manufacturers. The...
April 11, 2022
The FDA has released a draft guidance for cybersecurity in medical devices, which is a revised version of a similar document published in October 2018. If enacted as a final guidance as written,...
March 30, 2022
The FDA has released two guidances for appeals of regulatory decisions, one each for mammography facilities and the other for medical device premarket reviews. These are the first two final guidances...
March 24, 2022
On March 2, 2022, the US Food and Drug Administration (FDA) published the finalized guidance document titled, “Pre-Launch Activities Importation Requests,” or PLAIR. This document was updated from the...
March 7, 2022
The FDA final guidance for voluntary recalls applies to all FDA product centers, devices and drugs included, and offers some clarity regarding terminology. However, the agency urged companies to take...
February 28, 2022
The Food and Drug Administration (FDA) has continued to move towards harmonizing U.S. regulations with international standards for the regulation of medical devices. On February 23, 2022, FDA...
February 14, 2022
In January 2022, FDA released a new final guidance document titled, ‘Principles of Premarket Pathways for Combination Products’ which has caused many manufacturers to reevaluate their FDA compliance...
