FDA Releases New Draft Guidance for Remote Regulatory Assessments
RAPS Regulatory Focus reported last Friday that the US Food and Drug Administration (FDA) released draft guidance on July 22nd that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as we work our way out of pandemic protocols and codify “new-normal” modes of operation. The 17-page draft […]
Recognition of EN ISO 14971 as a harmonized standard in support of the European Medical Device Regulations
Back in June, it was reported by TC 210, the committee responsible for medical device standards such as ISO 14971 and ISO 13485, that the European standard EN ISO 14971:2019 with its amendment A11:2021 had finally been cited in the Official Journal of the European Union (OJEU) as a harmonized standard in support of the […]