New Guidance: Classification of IVD under the IVDR

CDRH COVID-19-Related Workload Impacts Q-Submission Reviews

In recent weeks, NAMSA has become aware of instances in which the U.S. Food and Drug Administration (FDA) CDRH Office has closed Q-Submissions without review, citing resource constraints stemming from the COVID-19 Pandemic. With the FDA’s commitment to protecting public health, the agency has allocated resources to focus on COVID-19-related activities, working alongside other federal, state and local agencies and officials to address the pandemic.

Industry Update: Accreditation Scheme for Conformity Assessment

As discussed in NAMSA’s December 19 blog post, “The Evolution of the Accreditation Scheme for Conformity Assessment,” ASCA is an assessment created by the U.S. Food and Drug Administration (FDA) following amendments to Section 514 by the FDA Reauthorization 95 Act of 2017 (FDARA). The assessment was initiated as part of the enactment of the Medical Device User Fee 96 Amendments of 2017 (MDUFA IV).

FDA Releases New Draft Guidance for Biocompatibility of Devices in Contact with Intact Skin

Update: PMDA Review Timelines for Medical Device and IVD Products

The Pharmaceutical and Medical Devices Agency (PMDA) is an independent administrative institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. One of the major functions of this agency is to review marketing applications of medical devices and in vitro diagnostic (IVD) products. In recent years, the PMDA has provided sponsors an annual report on review performance to assist in understanding the predictability and associated timelines for regulatory approval.