While you'll naturally undertake a broad range of compliance actions, your plan needs to reference the correct regulatory standards to make your work effective. Your ability to identify and meet the appropriate guidelines is crucial to building a functional quality management system.
What Is FDA Medical Device Compliance?
FDA medical device compliance is more complex than it seems. While it's obviously important that your finished devices adhere to safety rules pertaining to their function, you also need to pay attention to factors like how they're made, who inspects them along the way and what documentation the manufacturing process generates.
This last issue is a major stumbling block for many firms; the amount of documentation required to remain compliant with the cGMPs may quickly develop to a large volume.
For example, in addition to keeping track of device-specific quality parameters, you're also responsible for documenting factors in your production system that might impact device quality, such as deviations from normal conditions or periodic production errors.
However, not only does one have to keep this kind of documentation under control but also during the validation and documentation efforts required for supporting computerized systems such as ERP, EDMS and other laboratory systems is extensive.
Unlike some industries, where creating compliance documentation simply means checking off a box on a form, medical device manufacturers must implement comprehensive, FDA-ready quality systems that help them stay up to code.
Identifying a Good Starting Point
Firms that attempt to comply with FDA rules are often confounded by the sheer number of guidelines out there. Although getting started seems like a gargantuan task, documents like FDA CFR Title 21 Part 820 and the 21 CFR 800 series of regulations are great places to jump into the fray. Part 820, which pertains specifically to the Quality System Regulation (QSR) for medical devices, covers everything from basic definitions to the quality system features and controls you should ideally implement, so it's crucial that you gain familiarity with its contents. Other parts of the 21 CFR 800 series of documents pertain to topics such as:
- Establishment Registration – 21 CFR 807
- Medical Device Listing – 21 CFR 805
- Premarket Notification 510(k) – 21 CFR 807 Subpart E
- Premarket Approval (PMA) – 21 CFR 814
- Investigational Device Exemption (IDE) – 21 CFR 812
- Quality System Regulation (QSR)– 21 CFR 820
- Labeling – 21 CFR 801
- Medical Device Reporting – 21 CFR 803
Of course, things aren't that simple; though Part 820 covers basically everything to do with the QSR, it doesn't absolve you from the responsibility of actually deciding how to implement your compliance system and taking the necessary steps. You may not be responsible for certain aspects of the FDA 21 CFR regulations, but your quality system needs to suit your operations, so it's important to identify the applicable scope of the guidelines before embarking on a huge new compliance project.
Maintaining a Compliance System
Simply having compliance mechanisms in place isn't sufficient; you also need to ensure they function properly i.e. the compliance mechanisms that are implemented need to suit you daily work patterns and the manner in which your company manufactures the products it delivers to the market. For many firms, mock audits and similar self evaluations are the most reliable ways to vet the suitability of medical device compliance systems.
By subjecting your quality controls to rigorous, routine stress testing and evaluation of those controls, you get to see how they hold up to actual problems as well as prepare for real-world market trials and inspections.
Ultimately, your FDA medical device compliance efforts need to reflect your business goals. For many companies, such goals are easily identifiable, but the real trouble lies in connecting them with appropriate compliance tools. GxP-CC consultants understand what you're up against, and they possess the experience to help you get your operations in line. Contact them to put your firm on the path to FDA medical device compliance.