In a return to regular order, on April 16, HHS and FDA jointly withdrew a January 15, 2021 proposal issued by HHS under the prior administration recommending wide-spread 510(k) exemptions (the “Notice”). See 86 Fed. Reg. 20167, 20174 (Apr. 16, 2021) (available here and here). …
During the February 3rd meeting of the IVD Town Hall that OHT-7 has been hosting since early on the pandemic Office Director Timothy Stenzel proudly proclaimed: We have also really have ramped up our decisions. So we are currently over the last week averaging about nine …
We have previously posted about the heartache and anxiety that is the EUA process (here). Companies are waiting months for feedback from FDA and are frequently given comically short timelines for response. Another layer in this onion of poor management is the growing gap between the …
On April 2, 2021, the Ninth Circuit issued a decision in a False Claims Act (FCA) case against Medtronic. The Dan Abrams Co. LLC v. Medtronic Inc., No. 19-56377, 2021 U.S. App. LEXIS 9637 (9th Cir. Apr. 2, 2021). Relator appealed the U.S. District Court …
On March 31st, 2021 BARDA launched a competition to design tomorrow’s mask. The Mask Innovation Challenge, at its core, is about finding new mask designs that can be mass produced at a low cost and provide general protections against respiratory pathogens. One of the lessons …
FDA has long said that it would consider real-world evidence (RWE) in making regulatory decisions related to medical devices. Those in industry know that FDA can be very critical of RWE, however, and it is not always clear why RWE was (or was not) acceptable …
On March 17, 2021, FDA granted BioFire Diagnostics’ De Novo, making it the first COVID assay originally authorized on a temporary basis for this public health emergency to be given permanent access to the US market. While FDA has only released the signed letter affirming …
Over the past several years, FDA has faced criticism stemming from high-profile device issues related to materials, including the Essure permanently implanted birth control device and metal-on-metal hip implants. Given this, it is not surprising that device biocompatibility has received greater focus in FDA premarket …
On August 25th, 2020 Hyman, Phelps & McNamara, P.C. released a blog post covering experiences and lessons learned from our interactions with FDA and what was at the time the new and unfamiliar EUA pathway (FDA, Testing, and COVID-19: A “Mid-Mortem”). In the six months …
The FDA is legally established as a law enforcement agency. But its structure and activities have also generated its own “branding” as a trusted independent validator of medical devices. This public trust gives FDA tremendous power. If a device has not undergone FDA’s premarket review (even …
On March 16th, 2021 CDRH announced a major policy change for the EUA program in an effort to expedite screening testing for the pandemic. Screening is the testing of asymptomatic individuals who do not have known or suspected exposure to COVID-19 in order to make …
On Friday, March 12th FDA posted a letter to healthcare providers about performance concerns regarding the Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System. This public letter appears to be the culmination of a dialogue between Roche and …
On February 17th, 2021 the Biden Administration announced an expansion of the Federal strategy to test the population for SARS-CoV-2 with a three pronged approach: Expand COVID-19 testing for schools and underserved populations ($650 Million); Ramp up the domestic manufacturing of testing supplies and raw materials ($815 …
It’s not just drug companies that push the limit on marketing their products – see our posts about recent OPDP warning letters. Medical device companies are fighting for any edge to differentiate their products too. Even before COVID-19 brought an onslaught of new players to …
If you tuned in to FDA’s weekly Virtual Town Hall Meeting on February 10th, 2021 you would have seen a short presentation by Toby Lowe (CDRH/OHT-7) describing a recent funding announcement from HHS OASH, Office of Assistant Secretary for Health, and the DoD. This “Area …
