Katrina’s Blog™

The Accreditation Scheme for Conformity Assessment (ASCA) is a program being developed by CDRH to reduce the number of sponsor questions in areas where the agency has observed inconsistent practices with respect to testing and conformance declarations. These...

Small pharmaceutical companies are at a distinct disadvantage when it comes to understanding and accessing the process for new or generic drug approval. Many of these companies have one person fulfilling many roles, and their teams may have limited direct experience...

– new draft and final guidanceOver the past decade, the FDA has published a number of guidance documents on benefit-risk determinations for a variety of medical device application types. This fall the agency supplemented that guidance package by releasing two...

The FDA hosted a webinar in October in conjunction with release of the final guidance discussing the appropriate use and documentation of consensus standards in submissions as well as how the agency intends to rely on them during review. Consensus standards (also...

In a previous post, I mentioned the Bose Hearing Aid was approved by CDRH under the De Novo Classification Request process. This process allows CDRH to grant premarket approval for new devices for which there is no legally marketed predicate device as a newly...