FDA Audit Readiness Checklist For Medical Devices

An FDA inspection simulation can be an invaluable way to test how prepared your team is and identify areas where additional training might be necessary.

Medical device manufacturers should monitor the marketplace and be mindful of reports on similar devices that appear in FDA’s MAUDE database, while also being conscious of supplier quality issues.

1. Review your 510(k) submission
If your design controls and risk management have been effectively implemented, creating your quality system and filing your 510(k) should be relatively painless. This is especially true if using an external consultant to interpret regulations and organize your submission.

But things can become complex once you reach section 4.0: the Indications for Use Statement (FDA Form 3881). This section is often the cause of submission rejection by FDA; any experienced regulatory specialist should know how to avoid it. Essentially, this section asks you to demonstrate substantial equivalence between your device and that of its predicate; you’ll therefore need a deep knowledge of that device’s performance data as well as clinical studies; additionally, here you will include your risk evaluation analysis.

2. Review your design control process
An FDA inspector rarely visits firms on purpose; instead, their visits usually come about as the result of an open-ended request relating to issues with competitor products or an issue which needs evaluation.

During the design control process, firms record all activities related to device development in a master file called the Design History File (DHF). This document shows FDA where and why a particular device was designed. It documents what its intended uses are as well as its creation process.

A mock inspection helps your team learn how to best host an inspector by showing how quickly you can be ready in the “war room”, have access to all data and records needed, and answer their questions efficiently and effectively.

3. Review your risk assessment
When manufacturing medical devices, you must understand their associated risks. Knowing this allows your quality management system (QMS) to prepare itself for FDA inspections.

Conducting an initial risk analysis is a reliable way of identifying device characteristics that might pose hazards, by documenting intended use, device features and fault conditions as well as any possible hazards.

Although it’s essential to assess residual risks, you should avoid becoming overly preoccupied with ones outside your control. For example, if a device creates excessive noise beyond tolerable limits, design controls may be implemented as a solution; alternatively warnings and precautions in the IFU may be appropriate in certain instances, though this should always be seen as the last resort.

4. Review your design history file
The FDA regularly conducts unannounced inspections to assess your medical device company’s compliance with regulatory requirements, so it’s crucial that you maintain detailed records that demonstrate you adhere to all regulations consistently.

Your Design History File, or DHF, serves as the repository for records related to all design control activities, making it a critical component of overall design controls. While many companies struggle with creating and maintaining their DHFs accurately representing their product offerings, the FDA requires well-organized DHFs that accurately portray your designs.

If you plan to hire an outside firm to oversee your mock PAI, this provides the perfect opportunity to ensure that your DHF is in top shape for real inspection. A robust design and development process should be demonstrated, and DHFs offer just that opportunity.

5. Review your quality system
Be sure that your quality system is running at peak condition by conducting regular internal audits. Both FDA and ISO mandate medical device manufacturers conduct such audits.

An audit should form an essential part of any company’s management review process and must comply with applicable requirements. Such an examination should cover all aspects of a medical device firm’s quality system including, but not limited to:

An effective management review can ensure your medical devices are designed, developed, and manufactured according to regulatory requirements and are safe for patient use. Furthermore, it helps prepare you for a Pre-Approval Inspection (PAI), which typically includes reviewing clinical data supporting your product as well as your manufacturing processes.