Agency Puts Communications, Device Inspections at Center Stage

When communicating with FDA staff, it is vital that sponsors respond to agency questions during the timeframe requested, or they risk getting a hold letter with additional requests.

Sergio de del Castillo, acting de novo policy analyst within the Center for Devices and Radiological Health’s Office of Device Evaluation, offered that advice during the two-day FDA Small Business Regulatory Education for Industry meeting, which took place last week in Silver Spring, Md. “If you are not willing to work with them in that regard, we will be forced to take other options,” he cautioned attendees.

Del Castillo told the audience that company representatives discussing their products with agency staff should be ready to tell their stories, clearly explaining to reviewers why the device is safe and effective.

He also touched on Q-submissions, which are used for pre-submissions, informational meetings, study risk determinations, formal early collaboration meetings, submission issue meetings and PMA day 100 meetings. He emphasized that it is important for devicemakers to demonstrate that they have listened to agency review staff and considered their suggestions.

“It can be frustrating to the reviewer to take the time to have the dialog, and [he or she gets] the premarket application, and it looks [as if] you have not incorporated the feedback that we have given,” he emphasized. He tells devicemakers who include those suggestions to be sure to flag those sections in the submission. Those who have not should be prepared to explain why.

Del Castillo said he has fielded many questions on how often members of industry should contact agency staff. He instructed that while they may be anxious about their submissions, FDA staff members also have competing priorities.

He added that companies may face pages and pages of questions from agency staff during the interactive review process. That process is intended to allow for increased informal interaction between the FDA and applicants, with an eye toward preventing unnecessary delays in the application’s review. The FDA is not trying to intimidate companies with all of these questions, he said, but is aiming for transparency in a bid to obtain information in an orderly manner.

Inspections

Marc Neubauer, a medical device specialist at the FDA’s Baltimore District Office, provided an overview of what medical device companies should expect during inspections.

He said companies have false assumptions when an inspector comes to their door. For example, some contract manufacturers believe the agency doesn’t have the authority to inspect them, and that is not the case.

“No two FDA inspectors are alike,” Neubauer said, so a company can get zero observations during one inspection and 10 the next. It very much depends on the experience of the investigator.

To minimize any potential investigation surprises, Neubauer advised companies to do the following in the five days ahead of an inspection:

• Make sure you’re registered;
• Locate your listings;
• Coordinate document retrieval — if it is off-site, this will give you a chance to gather what you need;
• Obtain resources for the inspection, flying in support staff, if necessary;
• Review procedures, documents, open CAPAs and file MDRs; and
• Perform a complete makeover of your quality systems.

When asked what a firm may do if it disagrees with observations made during an inspection, Neubauer said companies may challenge the findings. If the observation remains on the Form 483, the firm may challenge it. Neubauer advised them to separate that observation from the rest of the findings. If the firm is judged to be correct, the FDA will send it an annotated 483. — Elizabeth Hollis