FDA Enforcement Action to Synovo Production, Inc.

I don't typically post about specific FDA enforcement actions, but this one (issued to Synovo Production, Inc. on March 23, 2023) is a remarkable example. The Warning Letter is somewhat unique in that the FDA cites the manufacturer for, among other things, 1) failing to obtain a new market authorization prior to implementation of changes that could significantly affect the safety or effectiveness of the device, and 2) failing to document aspects of the Quality System that are often taken for granted. Specifically, the agency cites the failure to document Management Reviews, Quality Audits, and Personnel Training.

Many manufacturers do not take seriously the obligation to ensure that ALL changes to their Medical Devices are evaluated and an adequate justification is documented (particularly to the extent a decision is made that a new market authorization is not required). As the Warning Letter indicates, this obligation is not just associated with design changes but also changes to the Intended Use of the product. Given how easy it is to change SaMD products, Digital Health and Digital Therapeutics manufacturers need to be careful. The FDA's new PCCP guidance will limit the need to obtain a new market authorization but does not eliminate the need to document the changes and the justifications for why a new market authorization is not required.

Likewise, many manufacturers also forget the fundamentals of a good Quality System. I can't count how many times companies look at me funny when I tell them that they have to document and control, for example, the job descriptions, personnel qualifications, and training records for all of their team members. Conducting annual internal audits and Management Review meetings is not optional, should not be difficult, and needs to be prioritized by management. Kudos to the FDA for reminding everyone!