FDA ISSUES DRAFT GUIDANCE ON PMA ANNUAL REPORTS

The FDA issued a draft guidance with recommendations on the level of detail needed to fulfill additional requirements for premarket approval (PMA) application annual reports.

Among the items devicemakers need to include in an annual report are:

A cover letter;

Manufacturing, design and label changes;

A detailed description of changes not reported in existing supplements;

A summary and bibliography of reports of scientific investigations and literature; and

Information on devices shipped or sold.

After it receives a firm's report, the FDA will either acknowledge it has received the report and that it is complete, request additional information or ask the firm to provide another submission if it did not meet the requirements for reporting changes to a device.

The "Draft Guidance for Industry and FDA Staff -- Annual Reports for Approved Premarket Approval Applications" can be viewed at www.fda.gov/cdrh/ode/guidance/1585.pdf (http://www.fda.gov/cdrh/ode/guidance/1585.pdf).