FDA Finalizes Guidance on Interoperable Medical Devices

On September 6, 2017, FDA finalized a guidance document entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices” (“Final Guidance”). In the Final Guidance, the agency outlines design considerations for manufacturers when developing interoperable medical devices, as well as recommendations about information to include in premarket submissions and device labeling. Interoperability of devices can encourage the availability and sharing of information across systems, even when products from different manufacturers are used. A draft of this guidance was issued on January 26, 2016.

The Final Guidance defines “interoperable medical devices” as medical devices “that have the ability to exchange and use information through an electronic interface with another medical/non-medical product, system, or device.” These functions can consist of a one-way data transmission to another device or product, or more complex interactions in which command and control is exercised over another device. An “electronic interface” is defined as the medium by which systems communicate with each other, and includes both the type of connection and the information content.

According to the Final Guidance, the agency considers the management of risks associated with an electronic interface incorporated into a medical device to be part of a comprehensive quality system under 21 C.F.R. Part 820. Manufacturers of interoperable medical devices should perform a risk analysis and conduct appropriate testing addressing the risks associated with interoperability, the anticipated users, reasonably foreseeable misuse, and reasonably foreseeable combinations of events that can result in a hazardous situation. In particular, the Final Guidance identifies the following considerations that manufacturers should take into account and “appropriately tailor[]” to the device’s interface technology, intended use, and use environments

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FDA compliant HPLC qualification and performance testing

FDA compliant HPLC qualification and performance testing is an important element of chromatographic test methods. Chromatographic test methods are used in a number of clinical applications.  The most common uses of chromatographic methods are in the quantitative and qualitative analysis of raw materials, drug substances, drug products and compounds in biological fluids. HPLC or High Performance Liquid Chromatography is obtained by the interaction and differential partition of the sample between the mobile liquid phase and the stationary phase.

Since HPLC forms an important aspect of pharmaceuticals, it needs to be validated. FDA compliant HPLC qualification and performance testing is the process of testing the reliability, reproducibility and predictability of HPLC qualification and performance in accordance with compliance standards set out by the FDA.

How to carry out FDA compliant HPLC qualification and performance testing?

When a pharmaceutical organization has to carry out an FDA compliant HPLC qualification and performance testing; it has to satisfy the test in relation to these among other important criteria:

  • Accuracy
  • Detection and quantitation limits
  • Linearity
  • Precision

Consequences an FDA compliant HPLC qualification and performance testing

One of the most important consequences of a pharmaceutical organization not having an FDA compliant HPLC qualification and performance testing is that it invites a Warning Letter and a 483 citation from the FDA. These citations can attract fines and penalties, apart from adversely impact the organization’s quality standards and reputation.




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