Your Next Trip to the Dentist…
Most of us would consider a trip to the dentist to be at most a minor inconvenience and would not spend much time worried about FDA Quality System Regulations or GMPs for the equipment used in providing our dental care.
However, in a recently posted warning letter, a manufacturer of dental devices including sealants, restorative materials, bonding/etching/bleaching agents, and metal and ceramic dental brackets received a 7-item warning letter. Issues identified included:
Failure to develop medical device products using design controls 21 CFR 829.30. As cited from the warning letter, the firm in the premarket notification identified that “all verification and validation activities were performed and the results demonstrated that the predetermined acceptance criteria were met” the FDA identified the following issues:
- Your design verification was conducted using prototype devices manufactured on un-qualified equipment;
- Clinical field testing performed as part of product validation were conducted using the prototype units in the absence of any clinical protocols;
- Your firm has not yet established manufacturing, inspection, testing, packaging, or labeling procedures for the device; and
- At the time of the 510(k) submission your firm had conducted R&D testing on only one partial bracket [redacted]. You had not assessed a manufactured full set (with differing in/out measurements). Furthermore, the brackets will be distributed with two wire-slot sizes and two configurations (with or without metal liner in the wire-slot); however, you have no evidence to demonstrate that your firm has evaluated both sizes and types of wire-slots.
Additionally, the warning letter identified that the firm failed to:
- adequately establish procedures for corrective and preventive action as required by 21 CFR 820.100(a).
- implement complaint handling procedures to ensure that all complaints are evaluated for determination if the complaint should be filed as a medical device report in accordance with 21 CFR 820.198(a).
- completely investigate complaints involving the possible failure of a device to meet any of its specifications per 21 CFR 820.198(c). Of more concern is that you have demonstrated a repeat failure to correct this issue as a duplicate citation was issued to your firm in 2010.
- train production employees responsible for quality functions as required by 21 CFR 820.25(b).
- document design verification results, including method(s), the date, and the individual(s) performing the verification, in the design history file for Avex CX2 and CXi2 (K113334) as required per 21 CFR 820.30(f).
- establish and approve design input requirements per 21 CFR 820.30(c).
As an informed consumer of health care products, perhaps during our next preventative or corrective dental checkup we should be asking our dentist a few pointed questions concerning the equipment used during our procedures or the devices that will remain on our teeth.