Risks vs Benefits: Applying the REF Rule in FDA Recalls

The FDA’s regulations and expectations for medical devices are designed to ensure that benefits outweigh the risks. In three months, the U.S. will formally harmonize 21 CFR 820, the Quality System Regulation, with ISO 13485 – Medical devices – Quality management systems and, by incorporation, ISO 14971 – Application of risk management to medical devices….
By: Gardner Law