Senate Bill Seeks To Improve FDA Inspections Of Medtech Facilities

A bipartisan bill filed by Sens. Johnny Isakson (R-Ga.) and Michael Bennet (D-Colo.) is seeking to make U.S. Food and Drug Administration (FDA) inspections of medical device facilities in the United States and abroad much quicker, more uniform, and more efficient.

The proposed bill would, among other changes, require FDA to notify manufacturers in advance to send pertinent records related to a scheduled inspection, and impose a reasonable time frame for FDA inspectors to perform foreign and domestic audits, during which time daily communication between investigators and companies is expected.

“In the case of inspections other than for-cause inspections, providing a reasonable estimate of the timeframe for the inspection, an opportunity for advance communications between the officers or employees carrying out the inspection … and the owner, operator, or agent in charge of the establishment concerning appropriate working hours during the inspection, and, to the extent feasible, advance notice of records that will be re quested in order to expedite the inspection,” states the bill.

Also, the measure would make more consistent different audit procedures covering foreign and domestic device companies.

Recent trends in FDA inspections reveal that a rapid and continuing rise in foreign manufacturer inventory has resulted in more Quality Systems (QS) inspections being done by FDA overseas – particularly in China – compared to the number performed in U.S.-based medical device establishments. A "learning curve" for facilities that are newer to U.S. regulatory standards, as well as growing concerns regarding quality in foreign facilities, are reasons cited for the increase of inspections abroad.

The bill would direct Department of Health & Human Services (HHS) Sec. Tom Price to “adopt a uniform process and uniform standards applicable to inspections of domestic and foreign device establishments” to help harmonize the inspection process, eliminate regional variations, and keep up with the rising number of inspections that need completion.

In addition, the measure seeks to improve communications between FDA and device companies to ensure timely implementation of any remediation plans if issues are identified during FDA inspections, and to establish a process for companies to address deficiencies more quickly and robustly.

AdvaMed issued a statement in support of the legislation, which seeks to correct what AdvaMed perceives as FDA's "lack of consistency, predictability, and transparency" in conducting inspections. AdvaMed stated that the measure hopefully "will help modernize FDA’s inspections process through a risk-based approach that will focus the agency’s limited resources on facilities that have the most potential to impact public health, improving overall patient safety."