ODE changes procedures in review documentation

The Food and Drug Administration's Office of Device Evaluationshas implemented new procedures to document the device review processand resolve disputes between reviewers and FDA supervisors. Theprocedural changes were apparently instituted to blunt internalcriticism about how decisions are made at the ODE.

"It is essential that the views of all persons involvedin the review of a device be respected and that the administrativefile on the application reflect differences of opinion when theyexist and the ultimate resolution of the differences," saidODE Acting Director Susan Alpert in an ODE guidance memorandumentitled, "Documentation and Resolution of Differences ofOpinion on Product Evaluations."

The Alpert memo further defines how reviewers can appeal thedecisions of their direct supervisors to higher authorities atthe FDA. The memo instructs staff that all paperwork accompanyinga decision--such as reviews, memoranda, checklists and flowcharts--mustremain part of the official record.

The memo, which took effect on Dec. 23, applies to the reviewprocess for 510(k), investigational device exemptions and premarketapprovals.

Alpert downplayed the memorandum's significance, stating thatit is simply a clarification of existing policy.

"The regulations provide for documentation of all decision-making,but the review staff felt that it would be appropriate to havea more definitive document," she said.

It was Congress that made the review process an issue. InJune 1993, the House energy and commerce oversight subcommitteeraised questions about the practice of overturning reviewers'decisions and about the documentation that accompanied such cases.Reviewers reportedly complained that supervisors were changingtheir recommendations without due cause.

Device applications are reviewed either by individual scientistsor teams of scientists and each of these primary reviews is approvedby a supervisor, Alpert said. The reviews and a draft action letter,reflecting the lower level recommendations, are then examinedby the division director or the ODE director.

Alpert expects differences of opinion to surface during thisprocess and informal consensus development to resolve many ofthe disputes. But in cases where consensus is not reached, a resolutionprocess is needed. That is one of the main reasons for the memorandum,Alpert said.

"It was felt by many frontline reviewers that having amore documented procedure for dealing with situations where thereis a difference of opinion between the initial reviewer and thesecondary reviewer or management staff would be appropriate andwould substantiate and require documentation in those instanceswhere they felt they were being overruled on their initial evaluation,"Alpert said. "The issue for them was to require accountabilityon the part of senior staff, when frontline reviewer decisionswere overturned."