OK here’s a quick quiz: which is the only part of the FDA’s Quality System Regulations apply to a manufacturer before they have received 510(k) clearance? Pat on the back for all who answered “21CFR 830.30” – that’s the Design Control regulation, and FDA requires that manufacturers comply with this regulation during the product development process prior to clearance.
And FDA will come right to your door and check.
Compliance with design controls is a routine part of FDA quality audits and that includes a retrospective look back to the records of the development process. Ask Cardiac Designs, manufacturer of the iPhone ECG, who found out the hard way and received an FDA Warning Letter last week alleging that the product is adulterated and misbranded.
More to the point, the breaches alleged by FDA relate to failure to comply with Design Controls at a sub contract software developer. Cardiac Designs subcontracted the development of the device software, but FDA allege that they were unable to produce records of design validation or verification.
Failures such as these provide grounds for FDA to revoke 510(k) clearances, to prevent import or supply of devices or to require recalls. The same is true in other jurisdictions. ISO 13485 Clause 7.3 contains equivalent requirements to 21 CFR 820.30 and jurisdictions who use ISO 13485 quality systems will insist on and audit design controls at least for Class IIa devices and up. For example the Japanese PMDA in its updated Medical Devices Law extended mandatory design controls to all Class II and III devices.
The key issue with the Cardiac Designs case is that the controls were not implemented by third party software developers. If you are using a software developer in your product development (and who doesn’t these days) make sure that they either have design controls implemented in house – or alternately – provide them with the support to ensure compliance: it’s possible to achieve design controls by building formal links between the developers processes and your own quality system.
So the lesson is clear – design controls really do matter and regulators will at audit time confirm that you complied during the product development – with real consequences if you weren’t up to scratch.
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