New Report Outlines Inspection Strategies for Devicemakers

This year should be a busy one for devicemakers as CDRH looks to enforce the UDI regulations.

“There are a number of UDI-specific quality system regulation elements that changed back in 2013,” according to John Avellanet, managing director and principal of Cerulean Associates. Avellanet said this will be the year the agency will look to ensure devicemakers are in compliance.

Even Class 1 devicemakers — which don’t need to comply with UDI requirements this year — should update forms and complaint database fields, according to an FDAnews management report.

It’s difficult to predict what other areas CDRH will look to enforce. However, Avellanet advises companies to review what areas the agency has emphasized over the last year, as well as trends over time.

Looking Back

Looking back over 2015, Avellanet says the most frequently cited item in 483s was CAPA, which should remain a top enforcement area. “But other areas have waxed and waned since 2012, often in response to past enforcement action,” he notes.

Avellanet expects the FDA to concentrate on four key areas during inspections this year: procedural controls and their effectiveness, supplier controls and oversight, record and data integrity and postmarket surveillance. Data integrity has been the focus of many 483s lately, he says, and devicemakers should take note.

“Last year, the FDA finished training all its CDRH investigators on the basics of data integrity,” he explains, “So I think we’re going to start seeing more and more data integrity inspections, much as we have in the pharma and biotech world for the past several years.”

He anticipates that the FDA will pay special attention to the following areas: data from automated processes associated with production or product testing; lot release data; sterility and safety data; and postmarket surveillance data.

A big trend for the agency over the coming years will be an emphasis on specialized inspections. Inspection teams will include a quality systems generalist and an expert on the device being manufactured.

Further, companies should anticipate big changes in the inspection model, as there is a “strong possibility” that the Medical Device Single Audit Program could replace the existing one.

Avellant provides his list of strategies devicemakers should keep in mind to avoid running afoul of the FDA:

  • Make sure you retain clear records to demonstrate safety and efficacy throughout the product’s lifecycle;
  • Expect two investigators in each inspection — one with more technical expertise than devicemakers may be used to;
  • Expect Class 2 device costs to increase as a result of phased-in UDI requirements;
  • Expect increased QMS costs for the year, as companies will have to update various SOPs, forms and databases to reflect the new rules;
  • Demonstrate progress on data integrity compliance;
  • Plan for increased liability risks from public enforcement of poor design control records and postmarket surveillance actions;
  • Improve supply chain controls to avoid public enforcement;
  • Expect FDA internal processes to change due to revisions of older guidance documents;
  • Consider restructuring your QMS to follow the seven-area MDSAP framework; and
  • Include relevant international guidelines as references in standard operating procedures. For more information on the report CDRH in Transition, visit: — Elizabeth Hollis

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