Compliance Corner

The US FDA compliance officer says medtech manufacturers would be wise to evaluate changes to stay out of hot water with the agency.

Morgan Lewis partner Dennis Gucciardo says there are steps device makers can take to make sure they’re not caught behind the 8 ball once the US FDA’s proposed Quality Management System Regulation is finalized.

Stryker Corp. regulatory expert Ommeed Shahrokh explains the device giant’s decision-making process around product recalls and describes what’s included in recall letters to customers.

King & Spalding quality expert Eric Henry urges device makers to be inspection-ready by making sure the right people are in the right roles.

Device makers presented with an affidavit by the US FDA during a facility inspection should walk away as quickly as possible, King & Spalding partner Jessica Ringel advises.

The US FDA’s Tom Peter offers advice, from determining a company’s “worst-case device” to identifying contaminants that work their way into the manufacturing process – and more.

Longtime industry expert Steve Niedelman of the law firm King & Spalding offers manufacturers pointers so they’re not caught flatfooted during regulatory meetings with the US agency.

From our archives: Despite the COVID-19 pandemic severely curtailing the US FDA’s ability to conduct on-site facility inspections, it’s still vitally important for manufacturers to remain audit-ready. In this collection of a 10-part Compliance Corner series, four longtime industry experts share evergreen advice on the best and worst things firms could do during an inspection.

If anyone understands the ins and outs of remote audits, it’s Christy Coleman. She’s VP of regulatory for Irrimax Corp., which has been through four virtual audits under the Medical Device Single Audit Program since the COVID-19 pandemic began. Coleman shares 11 best practices in this Compliance Corner feature.

King & Spalding’s Eric Henry urges manufacturers – particularly ones with facilities outside the US – to be prepared for a virtual audit under the Medical Device Single Audit Program. He explains how.

Longtime industry expert Connie Hoy says medtech companies that sign up for an audit through the Medical Device Single Audit Program will have a leg-up if they prepare beforehand by reading the MDSAP Companion Document. The doc can also be used to train workers on what an MDSAP auditor will be looking at and asking for.

A former US FDA investigations branch director explains how a paper-based “desk audit” would be performed by the agency in lieu of an on-site quality systems inspection. Last month the FDA hit the pause button on in-person inspections as the coronavirus pandemic rolls on.

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this tenth and final installment of a 10-part series, the experts explain why it’s important to be honest with investigators at all times.

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this ninth installment of a 10-part series, the experts talk about the importance of maintaining a record of the inspection.

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this eighth installment of a 10-part series, the experts urge firms to ask questions of the FDA’s inspection team.

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this seventh installment of a 10-part series, the experts address the use of SMEs – subject matter experts – during inspections.

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this sixth installment of a 10-part series, experts David Elder and John McKay address communication between the front room – where investigators do the majority of their work – and the back room, used by company workers to fulfill investigator requests for documents, records and other information.

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this fifth installment of a 10-part series, the experts address so-called front rooms used by manufacturers during an inspection.

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this fourth installment of a 10-part series, the experts address so-called back rooms used by manufacturers during an inspection.

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this third installment of a 10-part series, the experts address the do’s and don’ts of responding to investigator requests for information and records.