Article in User Facility Reporting Bulletin: PMA Submissions Now Due for Reprocessed Class III Single-Use Devices
This article was originally published in the Medical Device User Facility Reporting Bulletin, Issue No. 33, Winter 2001
PMA SUBMISSIONS NOW DUE FOR REPROCESSED CLASS III SINGLE-USE DEVICES
As of February 14, 2001, hospitals that reprocess class III single-use devices (SUDs) for reuse in humans are now required to submit premarket approval (PMA) submissions to the Food and Drug Administration (FDA). Class III devices are those medical devices generally considered to pose the greatest potential risk to the health of the public and require the most regulation. Three examples of class III devices are:
- percutaneous transluminal coronary angioplasty (PTCA) catheters,
- implanted programmable infusion pumps, and
- endotracheal tube changers.
FDA's basis for approval of a PMA submission is a finding that the device has a reasonable assurance of safety and effectiveness for its intended use based on valid scientific evidence. Clinical data may be necessary to establish the safety and effectiveness of a reprocessed SUD. The PMA submission also should evaluate the unique characteristics of the reprocessed SUD. A description of what FDA considers a complete PMA submission is given in the PMA regulation (21 CFR814.20). FDA has general guidance on the required information in a PMA submission (see "Guidance for Preparation of PMA Manufacturing Information".
The February 14, 2001, date is the first of FDA's announced enforcement dates for reprocessors of SUDs. On August 14, 2001, premarket notification submissions, also known as 510(k)s, will be required for all non-exempt class II devices. The non-premarket requirements which include registration, listing, medical device reporting, tracking (if applicable), corrections and removals, quality system, and label-ing will also be required on August 14, 2001. Finally, on February 14, 2002, 510(k)s will be required for all class I non-exempt devices.