September 28, 2022
On Monday, September 12, 2022, President Joe Biden signed an Executive Order to launch a National Biotechnology and Biomanufacturing Initiative. The official White House correspondence emphasizes that...
September 14, 2022
The FDA has released a final guidance for electromagnetic compatibility (EMC) for medical devices, a policy that applies to PMA, 510(k), and de novo devices. However, the scope of the guidance also...
September 13, 2022
The FDA has released a draft guidance for its use of remote regulatory assessments (RRAs), which is an outgrowth of the virtual inspections the agency conducted during the COVID-19 pandemic. These...
September 8, 2022
The FDA released the final rule for over-the-counter (OTC) hearing aids, which the agency said may assist nearly 30 million Americans in obtaining safe and effective devices at a lower cost than...
August 9, 2022
The COVID-19 pandemic brought to light the fragility of the pharmaceutical supply chain and demonstrated that disruptions can lead to drug shortages. We have written extensively about the...
August 4, 2022
President Joseph Biden has signed the CHIPS and Science Act of 2022, legislation that will make $52 billion in subsidies available to U.S. semiconductor manufacturers and billions more toward basic...
July 25, 2022
The shortage of semiconductors continues to present problems to the medical device industry, a critical issue for patients in need of devices that are largely or entirely dependent on these products....
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...
