As the end of the COVID pandemic appears into view, the Center for Devices and Radiological Health (CDRH) appears to be taking steps toward shedding at least part of its Emergency Use Authorization (EUA) caseload. Under Section 564(a)(1) of the Federal Food, Drug, and Cosmetic Act, …
A determination of “intended use” is fundamental to the U.S. Food and Drug Administration’s (FDA) regulation of drugs and medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). It is a primary basis for determining if an article is regulated by FDA, and …
On August 19, the Department of Health and Human Services (HHS) announced that FDA shall no longer conduct premarket review of laboratory developed tests (LDTs) under the Federal Food, Drug, and Cosmetic Act and implementing regulations (FDCA). The crux of the statement is this: “the …
In recent months, the Food and Drug Administration (FDA) has issued a record number of Emergency Use Authorizations (EUAs) under Section 564 of the Federal, Food, Drug, and Cosmetic Act (FDCA). With a large number also pending, this review pathway is becoming almost common for …
In the White House coronavirus updates, President Trump has commended FDA for working “around the clock” to expedite the review of new medical products to help with the testing and treatment of COVID-19. This is not puffery, as we at HP&M have experienced lightning fast …
FDA is exercising significant emergency authorities during the COVID‑19 pandemic. Not all of industry is affected, but those who are manufacturing or distributing (or using) devices being used to fight the pandemic can benefit by understanding FDA’s emergency‑related policies and practices. These are evolving every …
The COVID-19 pandemic has had a significant impact on day-to-day life for all of us in an attempt to “flatten the curve” to slow transmission of the coronavirus (SARS-CoV-2). However, for those of us involved in the development of medical products, quarantines, site closures, travel …
The FDA is taking very seriously the threat of the coronavirus from China (2019‑nCoV). Makers of medical devices, drugs and biologics should consider whether their products can contribute to countering this threat. In late January, FDA announced its strategy to advance development of medical countermeasures to …
FDA is issuing final guidance on how device firms may request review of a decision to withhold issuance of a Certificate to Foreign Government (CFG). What is a CFG? In many cases, foreign governments will seek official assurance that products exported to their countries are …
A warning letter issued earlier this year by the Food and Drug Administration (FDA) to Inova Genomics (Inova) prompts some reflections on where things stand now with the regulation of laboratory developed tests (LDTs) under the Federal Food, Drug, and Cosmetic Act (FDCA). An LDT, …
The Food and Drug Administration (FDA) regulates human cell, tissue, and cellular and tissue-based products, or HCT/Ps, under a unique regulatory regime set forth in 21 C.F.R. Part 1271 (Part 1271). An HCT/P that meets certain requirements is eligible for regulation as a “361 HCT/P.” …
A cutting-edge aspect of digital health is software as a medical device (SaMD) that uses artificial intelligence and machine learning to improve its performance based on real world use and experience. Until earlier this week, FDA has said very little about how to handle the …
Medical devices provide important diagnostic and treatment benefits to patients. Every day, thousands of patients are the beneficiaries of amazing technology that often did not exist even 10 years ago, and certainly not 50 years ago. At the same time, these medical devices can pose risks …
With a little over a year under FDA’s belt implementing its Comprehensive Regenerative Medicine Policy Framework (which we blogged about here), CBER has updated its current thinking with the issuance of final versions of the two Regenerative Medicine Advanced Therapy (“RMAT”)-related guidance documents: Expedited Programs for …
The 510(k) program is based on substantial equivalence. A 510(k) submitter wishing to market a new device must establish that it is as safe and effective as a legally marketed device that has already received clearance. The baseline comparison device is known as a “predicate …
