FDA, software firm clash over device maker status

Inspection Monitor, Dec, 1997

Medical Information Technology, Westwood, MA, New England District.

When FDA audited blood bank software manufacturer Medical Information Technology (Meditech) last December and January, the firm said it did not consider itself a medical device maker, according to a March warning letter (Doc. 5072W).

A 483 slapped the firm for not complying with regulations for a device master record, device history record, complaint handling, quality assurance and training. To this list the warning letter added lack of specification change controls.

Regarding the device master record, investigators John Hamilton and Joyce Watson cited a failure to address software requirement specifications, components, labeling, "description of the software design and development process [and] software architecture," the 483 indicated.

The agency also complained that procedures were not subject to a formal approval mechanism and the quality control procedures manual never addressed software customizations, the records said.

FDA wanted to see complaint-handling improvements, including review by a formally designated unit, identification of complaints that indicated a safety hazard and evaluation of com-plaints for their potential MDR status.

Quality audit procedures cited

FDA also cited a lack of quality audit procedures to cover the development of custom application groups. The procedures did not address regularly scheduled audits and were designed to be conducted by individuals who were responsible for the same areas being reviewed, the 483 said.

Training was not documented, the records added, and the company's employees were not familiar with GMP and MDR rules.

The records did not detail the deficiencies in the device master records, except to say that the records were not adequate.

Despite its earlier protest against being classified as a medical device maker, Meditech's reply to the warning letter showed that the firm had agreed to implement the systems FDA wanted.

Medical Information Technology, Westwood, MA, 12/17/96, 1/6, 8/97, Doc. 107870M, $3.00 plus handling.