What can FDA’s data tell you? Sometimes you learn something new ‒ other times the data validates what you already know.
FDA’s CY 2016 Annual FDA Medical Device Quality System Data reveals that Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC) continue to cause compliance headaches for medical device manufacturers.
The data addresses findings related to five quality system subsystem areas: Corrective and Preventive Action (CAPA), Production and Process Controls (P&PC), Management Controls (MGMT), Design Controls (DES), and Document Controls (DOC).… Read More
What: On March 14, 2017, FDA published a formal notice proposing to make hundreds of Class II medical devices exempt from premarket notification requirements that necessitate a 510(k) submission.* Note that there are a few exceptions for specific indications of medical devices. All devices will still need to meet other FDA requirements, such as 21 CFR 820 Quality System Requirements.
We view this shift as allowing FDA to focus its limited resources on higher-risk products in the 510(k) premarket notification pathway as well as the increasing number of 510(k) and de novo submissions being received.… Read More
Our customer, like many medical device manufacturers, had numerous risk management activities occurring in isolation. Risk management was addressed in design, manufacturing, validation, CAPA, complaints, and other areas, but there was no comprehensive process that served the business or could be articulated to an auditor. In addition, the company’s risk management files were static – the company was not updating the files with post-production, post-market, and other relevant data.
Through a combination of training and coaching, our customer’s in-house team learned how to build a systematic, dynamic risk management process and risk management files.… Read More
What Is MDSAP?
The Medical Device Single Audit Program – or MDSAP – allows a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory authorities (RAs). Five RAs: Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA (Japan), and the US Food and Drug Administration (FDA) participated in a three year MDSAP Pilot which concluded in December 2016. These RAs will continue to participate in MDSAP as the program moves into its operational phase starting January 2017, with Health Canada making a full transition from the Canadian Medical Devices Conformity Assessment System (CMDCAS) to MDSAP.… Read More
In May 2016, European Union (EU) institutions agreed to draft text for the In Vitro Diagnostic Device Regulation (IVDR) that will replace the existing In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC.
The new regulation introduces significant changes for IVD manufacturers that currently hold a CE Mark or plan to market their products in Europe. To start getting ready, Oriel STAT A MATRIX has compiled a list of high-level compliance changes that will need to be considered.
For a more detailed review, read our complete Market Update.
… Read More