FDA - Consensus Standards Update

A growing trend in the medical device industry has been the ongoing efforts by FDA to harmonize with international standards. The hope is that promotion of a uniform set of regulations will enhance efficiency for both medical device manufacturers and regulators on a global basis. One example of this initiative is the final rule for the Quality Management System Regulation (QMSR) which was issued by FDA back in January 2024. This rule serves to harmonize QMS standards between 21 CFR Part 820 and ISO 13485:2016.  Please see our Blog for more information -  FDA Releases Quality Management System Regulation (QMSR) Final Rule

Now, just this past September, we saw FDA take additional action to enhance consistency with the international community by formally recognizing the following standards with respect to medical device sterilization:

• ISO 11737-3:2023 Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing

• ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirement

• ISO 13004:2022 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD 

This recognition by FDA serves to not only promote the techniques contained in such standards and enhance innovation in medical device sterilization processes but also to facilitate the adoption of sterilization of medical devices and improve quality. It’s also important to note that FDA has stated that citing FDA-recognized standards with a declaration of conformity generally reduces the amount of supporting documentation needed in a device submission. 

If you need any assistance implementing or maintaining compliance with medical device or pharma standards in the Quality or Regulatory Compliance space, please contact us at PRP. We understand how challenging it can be to maintain compliance while managing your day-to-day operations. Our experienced Med Device/Pharma QA/RA consultants can seamlessly integrate with your team to fill any gaps in expertise or bandwidth, ensuring you stay on track with your compliance goals. We would welcome the opportunity to work together!