A bill filed this week in the U.S. Senate seeks to streamline FDA inspections of medical device manufacturers by creating a more transparent, risk-based approach applied consistently across the federal watchdog’s regional offices.
Sponsored by Sens. Johnny Isakson (R-Ga.) and Michael Bennet (D-Colo.), the bill would direct Health & Human Services Dept. secretary Dr. Tom Price to “adopt a uniform process and uniform standards applicable to inspections of domestic and foreign device establishments.”
That process would include advance notice of the type and nature of routine inspections, excluding “f0r-cause” investigations, “within a reasonable time before such inspection,” according to the bill, known as S.404 or “A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications.”
The bill also provides that “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.”
The FDA inspection measure would also require daily communication from the agency’s inspectors on the investigation’s status, “which may be recorded by either party with advance notice.” For inspections resulting in a Form 483 list of observed violations, the bill would give the FDA a 45-day window to answer to the company’s response.
Price would have 18 months to solicit public comments on the draft guidance for the new inspection procedures and issue final guidance. The bill was referred Feb. 15 to the Senate Committee on Health, Education, Labor, & Pensions.
AdvaMed president & CEO Scott Whitaker said the current inspections process “suffers from a lack of consistency, predictability and transparency, preventing both FDA and industry from addressing quality and compliance issues in an efficient manner.”
“The legislation introduced today 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,” Whitaker said in prepared remarks. “This legislation will lead to a higher level of patient safety and more efficient use of inspector time and effort, while not taking away any of FDA’s authority to inspect device manufacturing facilities.”