With the issuance last Fall of the US Food and Drug Administration (FDA) draft guidance entitled FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs), the agency has put manufacturers of LDTs on notice that they must begin notifying the FDA if they are developing LDTs and begin reporting significant adverse effects. FDA defines the term laboratory developed test (LDT) as an IVD that is intended for clinical use and designed, manufactured and used within a single laboratory.
Laboratories, as device user facilities, have always been subject to certain provisions of the Medical Device Reporting (MDR) regulations. User facilities are required to report to the device manufacturer (if known) and the FDA no more than ten work days after the day the laboratory becomes aware of information from any source that reasonably suggests that a device in use could have caused – or contributed to – the death of a patient of their facility. They’re also required to submit annual reports to the FDA that include information about each reportable event that occurred during the annual report period.
What’s changed by the guidance is the FDA’s intention to enforce manufacturer reporting requirements for laboratories that manufacture LDTs. That means laboratories producing LDTs are now required to submit reports to the FDA whenever they become aware of information that reasonably suggests that a device they market may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction would be likely to cause or contribute to a reportable serious injury or death should it recur.
Laboratories manufacturing LDTs must now:
- Submit MDR reportable events involving their medical devices as described in 21 CFR 803.10(c), 21 CFR 803.50, and 21 CFR 803.52
- Submit 5-day reports as described in 21 CFR 803.53
- Submit supplemental reports as described in 21 CFR 803.56
- Conduct an investigation of each event and evaluate the cause of the event as described in 21 CFR 803.50(b)(3)
- Develop, maintain, and implement written MDR procedures described in 21 CFR 803.17
- Establish and maintain complete files for all MDR events concerning adverse medical device events as described in 21 CFR 803.18(a) and (e)
These changes in reporting requirements do not affect all LDTs, however. The FDA has indicated that it does not intend to enforce adverse event reporting for:
- LDTs used solely for forensic (law enforcement) purposes and
- LDTs used in CLIA-certified, high-complexity histocompatibility laboratories for transplantation
These types of LDTs will not be subject to enforcement of applicable registration and listing, premarket review, or quality system requirements. The new guidance has stated that the FDA will continue to exercise enforcement discretion in full for these two LDT categories.
For all other LDTs manufactured by clinical laboratories, MDR reporting is changing and we’ll cover what needs to be submitted and how in our next blog post.