A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply. It is embodied in parallel drug and …
On the heels of Genus Medical Technologies’ successful lawsuit against FDA—Genus was represented by Hyman, Phelps & McNamara PC—in both the District Court of D.C. and the Court of Appeals for the D.C. Circuit, FDA published a Federal Register Notice today (August 9) soliciting comments …
For many years, one of the most controversial topics in device regulation has been the dual-track oversight of in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). Distributed IVD products are regulated by FDA, while laboratories that perform LDTs are regulated by the Centers for …
In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban. In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to …
On June 18th, FDA published a draft guidance document titled Remanufacturing of Medical Devices, which has been several years in the making. The draft guidance distinguishes between “remanufacturing” and “servicing” of devices. This distinction can be critical, due to the significantly increased regulatory requirements that …
In our last post on Laboratory Developed Tests (LDTs), we suggested that Congress, not FDA, should lead in directing modernization of LDT regulation. Any change should be made by enacting new law, and not by Food and Drug Administration (FDA) administrative fiat. Coincidentally, on the same …
You may recall that last summer (on August 19), the Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to cease premarket review of laboratory developed tests (LDTs), including COVID‑19 LDTs. At the time, we wrote favorably about this move. …
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 …
