If you’re transitioning a procedure set from a pure ISO 13485 baseline to the QMSR, here’s a non-applicability statement that almost certainly lives somewhere in your documentation:
§7.5.9.2 Traceability for Implantable Devices — Not Applicable. The organization does not manufacture implantable medical devices.
Clean. Defensible under ISO 13485 alone. And — under the QMSR — potentially wrong, depending on what you make.
The trap is hiding in §820.10(d), one of the QMSR’s specific FDA additions that overrides ISO scoping. It’s three lines of regulation that quietly extend §7.5.9.2’s heightened traceability requirements to a population of devices that have nothing to do with implants. The production and service provision post mentioned it in passing; this one is the deeper dive, because the “we don’t make implants” justification is going to be sitting in a lot of procedure binders that haven’t been updated since the transition.
What §820.10(d) Actually Says
The text is short, so let’s just look at it:
(d) Devices that support or sustain life. Manufacturers of devices that support or sustain life, the failure of which to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury, must comply with the requirements in Traceability for Implantable Devices, Clause 7.5.9.2 in ISO 13485, in addition to all other applicable requirements in this part, as appropriate.
That’s FDA reaching into a clause titled “Traceability for Implantable Devices” and saying: the title is misleading for our purposes. If your device supports or sustains life, you owe these requirements too. The language is a near-direct lift from the old §820.65, which applied the same heightened traceability to “any device that is intended for surgical implant into the body or to support or sustain life.” Same disjunction, same effect, different home.
What Counts as “Life-Sustaining”?
The operative definition is in 21 CFR §860.3(e):
Life-supporting or life-sustaining device means a device that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function important to the continuation of human life.
Two prongs, and the second one catches people. “Yields information that is essential” pulls in devices that don’t physically sustain anything, but whose readout is what keeps the patient alive. Combined with §820.10(d)’s additional “significant injury” qualifier, the operative QMSR test is: (1) does the device support or sustain life under §860.3’s two-prong definition, and (2) could its failure under labeled use reasonably cause significant injury.
The devices that obviously meet that test are about what you’d guess — ventilators, anesthesia delivery systems, ECMO, intra-aortic balloon pumps, external and implantable defibrillators, pacemakers, infusion pumps for vasopressors and insulin and parenteral nutrition, hemodialysis systems. The less-obvious cluster is where companies get surprised: ICU patient monitors and capnography, apnea monitors, certain critical-care glucose monitors, AEDs. All of those “yield information essential” to keeping someone alive, and an FDA investigator can build that argument quickly.
The LS/LS Flag — Your Shortcut
CDRH already maintains a “Life-Sustain/Support Flag” at the product-code level in the FDA Product Classification database. If your product code is flagged LS/LS, you’re on the hook for §820.10(d) and §7.5.9.2 — full stop. If your product code isn’t flagged, that’s evidence in your favor, but it isn’t dispositive on its own; you should still write down the reasoning.
And the flag is class-agnostic. Plenty of Class II products carry it: external defibrillators, ventilators, anesthesia delivery systems, hemodialysis machines. “We’re Class II” is not a defense.
What §7.5.9.2 Actually Asks For
Before you decide whether you can comply, it helps to know what compliance looks like. §7.5.9.2 goes beyond §7.5.9.1’s general traceability requirements and asks for records of components and materials used (lot-level traceability of inputs), records of conditions for the work environment if those conditions could affect safety and performance, distribution records maintained by the organization and by its distributors, and — the surprise for many manufacturers — the name and address of the shipping package consignee. Many manufacturers ship to a distributor and stop tracking; under §7.5.9.2, you or your distributor (contractually) need to know where the device went and be able to produce that record.
Writing a Non-Applicability Statement That Holds Up
If you’re confident §7.5.9.2 doesn’t apply to your devices, write the statement with citations, not assertions. A defensible non-applicability statement under the QMSR should cite the §860.3 definition and explain why your device fails both prongs, reference your product code’s LS/LS flag status in the FDA Product Classification database, and include a brief failure-mode summary showing why §820.10(d)’s “significant injury” qualifier doesn’t apply.
“We don’t make implants” was enough under ISO 13485 alone. It is not enough under the QMSR. The good news: if your devices genuinely aren’t life-sustaining, a three-citation non-applicability statement is still a one-page document. The bad news: if they are, you need real procedures — lot-level component records, work-environment records where they matter, and consignee traceability through distribution.
This is one of the QMSR’s quieter traps, and it’s the kind of thing that doesn’t show up until an FDA investigator finds the cross-reference. Worth ten minutes today to check whether your “not applicable” statement is built for ISO 13485 or for the QMSR. They are not the same document.