Here are a few links to recent quality management developments in the Medical Device Manufacturing industry.
US FDA Finalizes 510(k) Exemptions for Some Class I and II Medical Devices
The US Food and Drug Administration has finalized plans to exempt some “well understood” Class I and II medical devices from 510(k) premarket notification requirements, according to new guidance from the agency. Read More
Seven Mistakes that can Delay Your FDA 510(k) Clearance
- Inadequate device description
- Discrepancies throughout submission
- Problems with indication for use
- Failure to follow or address current guidance or recognized standards
- Comparison to predicate is missing or inadequate
- Other testing data is missing or inadequate
Warning! The 15-day rule for FDA 483s
Device makers are by now quite aware that FDA-inspected firms have 15 working days to respond to an inspectional form 483, but is this always consistently applied? It would appear not. Read More
Combination Product cGMPs: Your Compliance Strategy
Get advice on how to implement FDA’s rule on current Good Manufacturing Practices for combination products.
In January 2013, the FDA’s Office of Combination Products (OCP) released the final rule for 21 CFR Part 4 to address current Good Manufacturing Practices (cGMPs) for combination products. This regulation was followed up by a companion draft guidance published in January 2015 to further clarify the final rule and to provide additional recommendations on the application of cGMPs to combination products. Read More