Thank you to readers of this blog. We received incredible feedback on our August 19 post analyzing the number of decision summaries that have been posted for De Novos. We are happy to report that fifteen new decision summaries have been posted as of August 28. …
In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process. The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls …
The American Conference Institute (“ACI”) held its 11th Annual Summit for Women Leaders in Life Sciences Law at the Seaport Hotel in Boston, Massachusetts on July 25th & 26th of last week. Several leading ladies in law at HPM attended the conference and, based on their …
The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. § 360j(g)(9)(A)). For drugs, …
We recently blogged about the Center for Devices and Radiological Health’s (CDRH) reluctance to make full use of real-world data (RWD) and real-world evidence (RWE) to support marketing applications. In response to the post, we did receive feedback from a company that had had the …
FDA has long touted the use of real-world evidence (RWE). Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products …
Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts and sales for the most recent tax year, are eligible for a reduced fee on those medical …
The trio of CDER, CBER, and CDRH released a new draft guidance titled “Use of Data Monitoring Committees in Clinical Trials” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance. The new …
On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. The draft guidance provides recommendations for applicants and manufacturers about the requirements …
More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The final rule emphasizes risk management activities and risk-based decision making. …
In our June blog post, we reported on FDA’s request for comments about its program to receive information from the public alleging misconduct by other companies. FDA uses this program to help it identify risks and to determine whether further investigation is needed. Because this …
As we recently blogged, FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “Evidentiary Expectations for 510(k) Implant Devices.” Implant devices are used in a range of settings such as …
Over the last three and a half years, meetings with FDA were conducted virtually. During this time, CDRH moved from Webex to Zoom and gained experience with the virtual platform. Now, in addition to engaging with FDA via Zoom, medical device sponsors can once again …
The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP). Through ELP, CDRH staff visit sites that provide formal training and enhance understanding on topics such as how products are developed and …
Earlier this year, neither the Quality System Regulation (QSR) nor the Quality Management System Regulation (QMSR) were referenced in the semiannual regulatory agenda. We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring …
