Awareness into every scenario.
The pipeline of innovation continues to grow at a rapid pace within today’s medical device manufacturing industry. From the simple to the complex, new products are driving the future of healthcare forward. Awareness of all potential inspection scenarios is vital, regardless of where you currently are in the device manufacturing process. A knowledgeable team is a prepared team.
Premarket approval inspections
Any company with a Class III medical device on the market is familiar with premarket approval (PMA) inspections. It is a rigorous scientific and regulatory review by the U.S. Food and Drug Administration (FDA) to evaluate safety and effectiveness.
Emphasis is on the methods, facilities and controls per 21CFR (Code of Federal Regulations, Title 21) Part 820, which governs current good manufacturing practice (cGMP) guidelines. Inspectors will review all aspects of medical device design, manufacturing, packaging, labeling, storage, installation and service. The FDA approved 40 Class III medical devices in 2020, a 25% increase over 2019. (Source: S&P Global Market Intelligence)
PMA postmarket inspections
Inspectors may also conduct a PMA postmarket inspection within the first 8-12 months after a device has been approved. If you are slated for a follow-up inspection, you can expect the focus to be on specific aspects of the product that were not reviewed during the PMA process. The FDA will use this opportunity to look at your regulatory compliance in these areas:
- Corrections and Removals
- Medical Device Reporting (MDR)
- Registration and Listing
- Medical Device Tracking
Routine surveillance inspections
Routine inspections of Class II and III medical devices generally occurred on a two-year cycle prior to the pandemic. While frequency has slowed, the importance of staying vigilant has not. Your next visit from the FDA will follow the Quality System Inspection Technique (QSIT).
Inspectors will choose two of the four Quality Management (QMS) subsystems–management controls, design controls, corrective and preventive actions, or production and process controls – to review. Inspectors regularly focus on the Corrective and Preventive Action (CAPA) subsystem. They will choose a random number of CAPAs from your list to look at how you are:
- Gathering and analyzing information
- Spotting and examining problems
- Taking corrective and/or preventive actions to avoid future issues
- Providing objective evidence that corrections are effective in solving for specific issues
For-cause inspections are typically unannounced and occur based on information of potential problems received by the FDA, either from previous inspections and/or external sources. For-cause inspections take place to follow up on CAPAs or investigate the following scenarios and more:
- MDR filings
- Application data
- Product complaints
- Adverse events
- Device recalls
Inspection readiness is a key factor in maintaining an efficient and profitable operation. The differentiator comes down to knowledge and experience, ensuring that your team is prepared for what comes next.
The FDA maintains a robust medical devices website with volumes of information to cull through. But time is at a premium in today’s fast-paced medical device industry. Understanding exactly where to put your energy is essential for success in inspection readiness.