J&B Consulting Launches U.S. FDA Medical Device GMP Audit Preparation Consulting!

J&B Consulting Launches FDA Medical Device GMP Audit Consulting

Due to COVID-19, FDA medical device audits were temporarily halted, but they resumed in full force late last year. Any medical device that wishes to enter the U.S. market must be registered under Class I, II, or III to be eligible for export.

However, many companies overlook the fact that FDA regulations require ongoing quality management and compliance even after entering the U.S. market.

As a result, many businesses fail FDA audits, preventing them from continuing operations in the U.S.

What is FDA QSR (Quality System Regulation)?

The Quality System Regulation (QSR) is the current set of FDA regulations governing medical device quality systems.

These FDA quality system regulations are outlined in 21 CFR Part 820, covering:

Quality management and organizational requirements

Device design and structure

Equipment, purchasing, and component handling

Manufacturing and process control

Packaging and labeling regulations

Device inspection, distribution, and installation

Complaint handling, inspections, and recordkeeping

Many companies mistakenly believe that passing international standards, such as ISO certifications, is sufficient for FDA approval.

For example, ISO 13485 provides international quality management standards for medical device manufacturers. In 2022, the FDA proposed a draft regulation known as QMSR (Quality Management System Regulation), which integrates QSR with ISO 13485. This new regulation is expected to take effect soon.

Preparing for FDA Audits

To prepare for FDA inspections, seeking guidance from regulatory experts with in-depth FDA audit experience can be a strategic approach.

Some effective compliance strategies include:

Regularly engaging certified regulatory consultants to assess and improve quality management systems.

Proactively addressing FDA compliance issues before they escalate into major violations.

The FDA itself strongly encourages companies to work with experienced regulatory consultants to ensure compliance and avoid unnecessary risks.

Feel free to contact us

jay@jnbfoodconsulting.com or 714-873-5566