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Comment Period Closes for FDA’s Draft Guidance Document, "Risk Management Plans to Mitigate the Potential for Drug Shortages"

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...

Congress Passes Semiconductor Legislation

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...

Semiconductor Shortage Still a Concern for Device Makers

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....

New FDA Program for Ethylene Oxide Encourages Use of Alternatives

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...

House User Fee Bill Emphasizes Inspections

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...

User Fees Could Reach $1.9 Billion in MDUFA V

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...

AdvaMed Revises its Code of Ethics

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...

FDA Reissues 2018 Draft Guidance for Cybersecurity

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The FDA has released a draft guidance for cybersecurity in medical devices, which is a revised version of a similar document published in October 2018.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,...

FDA’s Device Center Issues Two Guidances for Appeals

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...

FDA Publishes Finalized Guidance Document for Pre-Launch Activities Importation Requests (PLAIR)

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...

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