FDA Issues Warning Letter for Unapproved Medical Device for Significant Product Quality and Corrective Action-Related Violations

Footnotes for this article are available at the end of this page.

The Food and Drug Administration issued a Warning Letter to a medical device company after conducting an inspection of the facility’s medical device operations.1   FDA reviewed the firm’s labeling for the device, the design change assessment, and the response to the FDA Form 483. FDA disagreed with the company’s conclusion that the addition of a device to its 510(k)-cleared device was merely a design change. Rather, FDA concluded that the addition was a new and different device, requiring a new regulatory submission for the whole product. As such, the marketed product was misbranded and adulterated.

FDA’s inspection revealed that certain statements in the device labeling demonstrated that the device was a separate accessory to a radiation therapy device, and not part of the thermoplastic device. The agency cited certain statements, such as that the device is to be “used with a thermoplastic mask…for radiation therapy treatment,” for its argument that the device was a separate accessory to a radiation therapy device, and not part of the thermoplastic device. FDA also determined that the device had different indications for use than the indications for use of the FDA-cleared device and noted that devices with similar designs and indications had been cleared as class II accessories to radiation therapy devices. FDA requested that the company submit a new 510(k) premarket notification.

Other Violations

The Warning Letter also cited the company for a number of additional violations, including the following:

  • Failure to submit a report within ten working days of initiating a correction or removal (g., the company recalled a defective product, but failed to communicate the recall to customers);
  • Failure to establish and maintain procedures for implementing corrective and preventive action (g., the firm failed to follow its own procedure for when employees become aware of quality incidents, issues requiring action, or possible preventative actions);
  • Failure to demonstrate that the product design was developed in accordance with the design control requirements of the Quality System Regulation and failure to establish a Design History File;
  • Failure to establish and maintain procedures for the identification, documentation, validation or (when appropriate) verification, review, and approval of design changes before implementation;
  • Failure to develop, conduct, control, and monitor production processes that ensure the device conforms to its specifications (g., failure to establish or document instructions, standard operating procedures, or methods to define and control the manner of production for manufacturing processes);
  • Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements (g., a failure to include an agreement (where possible) that suppliers, contractors, or consultants agree to notify the firm of changes in the products and/or services so that the firm can determine if the changes may affect the quality of the finished device);
  • Failure to establish and maintain procedures for rework to ensure that the product meets its current approved specifications (g., during the FDA inspection, the General Manager stated that repairs of the product had been made on at least two different occasions, however, the rework, including the retesting of the products, was not documented in the device history record);
  • Failure to establish and maintain procedures for acceptance activities (g., certain products that were accepted and distributed by the firm were documented on the inventory list with “bad fabric” and were identified to be defective); and
  • Failure to ensure all complaints are processed in a uniform and timely manner according to the firm’s complaint procedures.

The Warning Letter included boilerplate language about failure to address FDA’s concerns. FDA directed the firm to take prompt action to address the violations in the Warning Letter, noting that failure may result in regulatory action initiated by FDA without further notice, such as seizure, injunction, and civil money penalties and federal agencies may take the issuance of the Warning Letter into account when considering the award of contracts. FDA requested that the firm submit a certification by an outside expert consultant certifying the performance of an audit of the manufacturing and quality assurance systems relative to the requirements of the device Quality System regulations (21 C.F.R. Part 820). FDA also requested submission of the consultant’s report and a certification by the establishment’s Chief Executive Officer that the CEO reviewed the consultant’s report and that the establishment initiated or completed all corrections called for as a result of the report.

AGG Observations
  • The Warning Letter reiterates FDA’s long-standing stance that a medical device may be labeled and promoted only for its cleared or approved intended uses. Despite past First Amendment legal challenges to FDA’s authority in the promotional arena (where we have advised and written), the agency will not sit idly by if it objects to what it considers unlawful marketing or distribution of an unapproved product.
  • One thing may lead to another – FDA’s Warning Letter may have outside consequences for the firm if federal agencies take the issuance of the Warning Letter into account when considering the award of contracts.
  • It is important to thoroughly assess any changes to a 510(k)-cleared device to evaluate whether a new regulatory submission is required. A company should look at the potential effects on safety, efficacy, and intended use, and any labeling claims made.
  • The Warning Letter followed another Warning Letter, issued two years earlier. A number of the observations cited were “repeat violations.” The company should not expect a third Warning Letter if it fails to correct its deficiencies; FDA will likely seek court assistance, such as a product seizure or injunctive relief if non-compliance continues. Third-time failure will not be a charm.


[1] The Warning Letter is available at the following link: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/klarity-medical-products-llc-606982-06082020.