PMCF and PMS can be confusing when comparing the FDA's requirements to those of the EU MDR. This is because FDA uses some of the same terminology, yet with fundamentally different meanings. Specifically, the activities called 'PMCF' by the EU MDR are instead called 'PMS' by the FDA. Moreover, when FDA does use the term 'PMS', it means something fundamentally different than 'PMS' under the EU MDR. I explain further below:
- For a 510(k) device, the FDA might require (but not usually) an analogous type of study that is much like EU MDR 'PMCF'. But FDA calls this type of study 'PMS' and has promulgated its corresponding requirements at 21 CFR Part 822.
- Such FDA 'PMS' (i.e., the analog to EU MDR 'PMCF') is generally demanded by FDA at or after approval or clearance of a subject device. FDA generally restricts this type of study only to significant risk devices (my paraphrased term; please read or inquire further about Part 822 and 21 U.S.C 360l for the general regulatory/statutory categories of affected devices). In practice, the specific types of devices for which FDA has traditionally called for PMCF (i.e., FDA 'PMS') are most often orthopedic, general/plastic surgery, and obstetrics/gynecology devices.
- Don't forget that EU MDR PMCF (i.e., FDA PMS) is often not required at all; see my various other Forum posts explaining that notion further in the context of the EU MDR.
- FDA's analog to EU MDR 'PMS' is embedded in the requirements of FDA's 21 CFR §820.100(a)(1). This is applicable to all finished devices except those that, by regulation, are FDA GMP-exempt. FDA requires written procedures for this. Those written procedures are generally expected to assure that there is a corresponding plan for such monitoring, measurement, and reaction. In addition, the execution of this needs to be reported. Accordingly, these FDA §820.100(a)(1) requirements for a 510(k) device are analogous to EU MDR PMS, PMS Plans, and PMS Reports. However, the EU MDR is more prescriptive.
- As said above, FDA doesn't officially use the name 'PMS' for the §820.100(a)(1) post-market monitoring. But we know it's analogous to EU MDR PMS because of, for example, FDA's corresponding expectation that trigger/action levels be established for the post-market data being analyzed. These include, but aren't limited to, complaint data or other sources of quality data. FDA investigators are trained to look for this.
- In contrast, FDA's 21 CFR §820.198 doesn't contain this type of post-market monitoring and analytical requirement. Instead, §820.198 is focused on the receipt, documentation, and proper resolution of individual complaints. Yet, it is certainly fair to say that the aforesaid post-market analysis isn't possible without first collecting the raw data pursuant to §820.198.
- As an aside, note that this same arrangement/dynamic is built into ISO 13485 clause 8.4 and its subcategory 8.2.1. This similarity between FDA §820.100(a)(1) and ISO 13485 clauses 8.4 and 8.2.1 is no surprise, as both were originally modeled after ISO 9001.
Finally, let me answer your question about continuously updating the 'Clinical Evaluation' for the FDA. The FDA's corresponding requirement for this is again less prescriptive than under the EU MDR. But make no mistake; FDA definitely expects its version of a clinical evaluation and ongoing updates. Specifically, it is embedded within FDA's design control requirements. More specifically, a proper FDA design change mechanism needs to lead to updates of the clinical evaluation (an output of the design validation stage) where applicable. For example, in guidance, FDA has stated, "…Many medical devices do not require clinical trials. However, all devices require clinical evaluation and should be tested in the actual or simulated use environment as a part of validation…While testing is always a part of validation, additional validation methods are often used in conjunction with testing, including analysis and inspection methods, compilation of relevant scientific literature, provision of historical evidence that similar designs and/or materials are clinically safe, and full clinical investigations or clinical trials…" [emphasis added].
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 11-Sep-2022 23:40
From: Anonymous Member
Subject: PMCF
This message was posted by a user wishing to remain anonymous
Hello Everyone,
Greetings.
I would like to know if FDA has any requirements of PMCF for 510k Submission.
I know that EU MDR states the requirements of PMCF for CE Marking in Annex XIV part B, similarly, are there any requirements for 510K? If there is then what CFR would that be? And if there is not what is the alternative for continuously updating the Clinical Evaluation?
Additionally, my second part of the question is about PMS Plan. Is there any requirement for a PMS Plan for 510k? And since PMS Plan for EU MDR needs to have a section of PMCF activities, in case FDA does not require a PMCF, are two PMS Plans needed to be created?
Thank You.