Does More FDA Oversight Equal Better Compliance?

Since 2007, FDA has increased its annual number of medical device inspections by 46% and has increased annual inspections of foreign firms by 243%. In that timeframe, the agency also helped establish the Medical Device Single Audit Program, which has increased its oversight of foreign manufacturing facilities beyond the inspections the agency performs on its own. The question is, have these actions translated into improved quality compliance? The short answer, according to a new report issued by FDA's Center for Devices and Radiological Health (CDRH), is yes. According to the Medical Device Enforcement and Quality Report, FDA's focus on identifying reporting deficiencies during inspections has led to an increase in voluntary recalls and adverse event reporting. Even better, the report suggests that most firms (82% between 2008 and 2017) have corrected violations on follow-up inspections. The agency attributes this improvement to a more interactive approach regarding observed violations. Several sessions at MD&M West 2019 will focus on regulatory and quality issues that impact medical device companies, including a session on FDA's Case for Quality program, and a session on the Medical Device Single Audit Program. Don't miss these sessions and more, Feb. 5-7 in Anaheim, CA. “As medical device manufacturing has become an increasingly global enterprise, the FDA has taken forceful action to increase inspections of medical device firms, especially ...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news