Our practice lead, Teresa Gorecki, recently shared her LinkedIn article that addresses new medical device regulation changes with a recent FDA rule on medical device regulation harmonization. The article below shares information on the change, what it means, what we know, and what we should do.
Table of Contents
Introduction
Those of us working in the Medical Device and Combination Product industry face many regulatory requirements that vary significantly from one country to another.
This lack of harmonization can lead to delays in initiating and/or implementing critical changes to product designs and/or manufacturing processes needed to address device malfunction trends and product safety issues.
Harmonizing medical device regulations globally is not just a challenging goal; it is an essential step toward improving medical device function and reducing risks to patient safety.
What is the Current State of Medical Device Regulation?
Medical device regulations differ widely across major markets such as the United States, European Union, and Asia. Each region has its own set of standards, approval processes, and compliance requirements, posing significant challenges for manufacturers.
- United States: The FDA oversees the regulation of medical devices, ensuring they meet stringent safety and efficacy standards. The recent FDA Rule aligns device current good manufacturing practice (CGMP) requirements with ISO 13485:2016 aims to modernize and harmonize U.S. regulations with international standards.
- European Union: The EU MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) have replaced the older directives, introducing more rigorous requirements for clinical evidence, post-market surveillance, and overall compliance.
- Asia: Countries like Japan, China, and India continuously evolve regulatory frameworks. Japan’s PMDA and China’s NMPA have unique requirements, while India is working towards more structured regulations through Harmonizing medical device regulations, which offers substantial benefits for both manufacturers and patients.
What is the REAL Impact of the Final FDA Rule on Harmonization of the current Quality System Regulations (FDA §21 CFR Part 820) with ISO 13485:2016?
My grandmother had a saying: “The more things change, the more they stay the same.” She said this long before this saying was incorporated into the lyrics of “The More Things Change” by Bon Jovi.
She also said: “There are three sure things in life. Change. Taxes. Death.” I somehow feel both apply in this situation.
Many companies in the Medical Device Industry were hoping FDA would accept “Notified Body” inspections and ISO 13485 certification in lieu of an FDA Inspection. The Final Rule was very clear on this point.
FDA stated in the Final Rule regarding Inspections:
“FDA disagrees with the comments (made to the Proposed Rule by Industry and other interested parties) that it would be appropriate to accept certification to ISO 13485 in lieu of FDA inspection.”
“FDA does not intend to require medical device manufacturers to obtain ISO
13485 certification and will not rely on ISO 13485 certificates to conduct its regulatory oversight of medical device manufacturers. For example, an ISO 13485 certificate will not be considered or accepted as a substitute for any oversight processes, including the performance of an inspection under section 704 of the FD&C Act or generation of an EIR.
FDA inspections will not result in the issuance of a certificate of conformity to ISO 13485. FDA’s obligation remains to inspect medical device manufacturers to confirm compliance with the requirements of the FD&C Act and its implementing regulations, including not only the QMSR, but also other FDA medical device requirements, such as parts 803, 806, 821, and 830.”
FDA did state in the Final Rule that they intend to modify their current QSIT inspection approach to be consistent with the requirements. They did not have any information to share on what the new approach will be at the time the Final Rule was published.
What FDA has said is they are amending §21 CFR Part 820 to incorporate reference to ISO 13485. As I understand this statement, I envision the following:
In addition to the information on the future of Registered Medical Device company inspections, FDA provided information on the harmonization of §21 CFR Part 820 with ISO 13485.
Here is what FDA stated in the Final Rule regarding Regulations:
“We are amending Part 820, primarily to incorporate by reference ISO 13485, Medical Devices–Quality Management System Requirements for Regulatory Purposes. While the QS regulation provided sufficient and effective requirements for the establishment and maintenance of a QMS, regulatory expectations for a QMS have evolved since the QS regulation was implemented over 20 years ago. By incorporating ISO 13485 by reference, we are explicitly requiring current internationally recognized regulatory expectations for QMS for devices subject to FDA’s jurisdiction. This resulting regulation is referred to as the QMSR.”
What does all of this mean, EXACTLY?
Regarding Inspections:
Registered Medical Device Manufacturers selling product into the US market will be inspected by FDA; there is no change to FDA’s inspectional authority under section 704 of the FD&C Act (21 U.S.C. 374). This question has been answered. While the inspection approach may change, the fact that FDA will still be conducting inspections is very clear.
Regarding Regulations:
§21 CFR Part 820 will be modified to have direct references made to the relevant sections of ISO 13485 throughout the Regulation. Indeed, in the Final Rule, FDA included a list of the changes to be made within Part 820 of the Regulations that have been decided upon.
Here are a few examples that have been decided upon to date, many related to definitions:
· Revise § 820.3(a) to clarify use of definitions from ISO 13485 and ISO 9000 in this rulemaking.
· Revise § 820.3(b) to clarify use of definitions from ISO 13485 and ISO 9000 in this rulemaking.
· Add to § 820.3(b) clarification of term “implantable medical device.”
· Revise § 820.35(a) to clarify expectations for record keeping related to complaint handling. Revise § 820.35(a)(6) to add “correction.”
· Revise § 820.45 to replace the term “establish” with the term “document,” and replace the term “where appropriate” with the term “as appropriate.”
· Revise § 820.45(c) to remove the term “immediately” with respect to inspection of labeling and packaging.
FDA was clear to state that these changes do not “fundamentally alter the requirements for a QS that existed previously”, FDA maintains its expectations regarding the need for an effective Quality Management System.
FDA went on to state in the Final Rule that the application of ISO 13485 without clarification or modification could create inconsistencies with FDA’s statutory and regulatory framework. FDA has stated that where possible, FDA is accepting the incorporated requirement without modification or will create requirements that will supersede the correlating requirement in ISO 13485.
So, what do we NOW Know?
1. We will continue to have FDA Inspections for all registered device manufacturers globally if they produce products distributed in the US market.
2. §21 CFR Part 820 will be modified to have direct references made to the relevant sections of ISO 13485 throughout the Regulation. The revised Regulation will now be called the “QSMR” and will replace the “QSR”.
There will be a revision to the US Regulations, they will NOT be eliminated. It is not as simple as ISO 13485:2016 is now the US Regulation. We can anticipate this will take up to two years from the date of the Final Rule.
3. There will be an alignment of definitions and as much of ISO 13485:2016 as possible will be incorporated “as is”.
4. Where there is a lack of alignment, FDA will create new requirements that will be enforced and will supersede the corresponding ISO requirement.
What Should We Begin to DO?
· If you have not begun to compare the requirements in §21 CFR Part 820 to ISO 13485, you should initiate a project to initiate that review. I would recommend
developing a “trace matrix” for your current Quality Management System Element SOPs, comparing the contents of those SOPs to both §21 CFR Part 820 and ISO 13485.
As part of that project, I would begin to “red line” those SOPs, aligning the definitions and other content referenced in the Final Rule to the ISO definitions. I would hold those red-lined documents and wait for FDA to complete the harmonization prior to completing the revisions needed.
Once FDA finalizes the new QSMR Regulations, there will likely be a “grace period” for registered device manufacturers selling products in the US market to make the needed revisions to align fully to the new QSMR. Until the QSMR is published, FDA will hold you accountable for compliance with §21 CFR Parts 820, 803, 806, 821, and 830.
It goes without saying, I would ensure a robust risk management QMS Element SOP is in place and complaint with ISO 14971.
- If you have started aligning your firm’s existing Quality Management System Element SOPs to ISO 13485, I will continue with one caveat. FDA is making choices and will likely accept the ISO 13485 language “as is” as long as it does not change the “essence” of the existing Regulation as stated in §21 CFR Part 820.
- The objective of harmonization is, by definition, alignment. This effort is not intended to relax or loosen the existing Regulations. FDA clearly stated that it will, if needed, create requirements that supersede the corresponding requirements in ISO 13485.
- If you have loosened requirements for any given Quality Management System Element to fully align with ISO 13485, you should reconsider the revisions you have made or intend to make.
- You should continue to attend industry meetings and stay current on the information the FDA publishes in the Federal Register regarding the Medical Device Harmonization Final Rule.
One last thing to remember, this harmonization effort is between §21 CFR Part 820 to ISO 13485. There are efforts to modify, update and potentially harmonize the medical device regulations in Asia and Latin America. Having a process in place to fully understand the picture globally will be critical for device firms with a global footprint.
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