March 2, 2023

Regulatory is Part of the Design and Design Team: Part 2

Here are a few more practical examples generally demonstrating that Regulatory can’t be separated from the design team.

For example, if a Regulatory staffer compiled the GSPR matrix or an FDA 510(k), then that unfortunately means that staffer wrote regulatory design outputs.  For example, ISO TC/210 includes as design outputs, “documentation for submission to the regulatory authorities“.  This is because ISO 13485 (and FDA) have very deliberate and distinct requirements for regulatory inputs, outputs, etc., as distinguished from the subject device’s functional and performance requirements.  Be sure not to equate the regulatory inputs/outputs with the device’s functional/performance requirements that might be embedded or referenced within the regulatory outputs.  Again, for these reasons, I don’t expect that a notified body, an ISO registrar, or FDA would buy the assertion that the team’s regulatory contributor isn’t part of the design team, nor do I expect these authorities to accept attempts to have said regulatory contributor be the independent reviewer or “other specialist personnel” regarding those regulatory inputs/outputs, verification, etc. Consequently, if one fought the regulatory authority in such instances, then I expect that you could not only lose that battle, but also in the process damage the organization’s relationship with the regulatory authority, and thus the organization’s premarket authorization efforts.  There are certainly proper times to push back on a regulatory authority; but this doesn’t seem to be one of them.

I also think it’s a losing battle to argue that a primary author/contributor of a critical part(s) of the device specification and/or IFU, such as adding (i.e., writing) an indication for use consistent with the predicate, isn’t a design team member.

Similarly, if a person signed off on and/or “completed” process, packaging, and sterilization validations, then again, then I expect it will be a losing battle to argue that such person isn’t a design team member.

Likewise, if a team member reviews the design verification/validation protocols and reports for regulatory compliance (meaning that such member is participating in design verification/validation), then I view it as a stretch (or worse) to assert that such person isn’t part of the design team.

It’s also important to be mindful that ISO TC/210 and FDA expect the design team and its members’ roles to be very clearly defined (i.e., in the design plan).  FDA says that, “The importance of defining responsibilities with clarity and without ambiguity should be recognized.”  ISO TC/210 says, “It needs to be clear who has responsibility and authority for design and development. Generally, as different groups or functions within your organization are involved in design and development, clear and effective communication with distinct assignment of responsibilities across your organization is important….The design and development plan should identify the review, verification and validation methods to be used, including who is to carry them out…” [emphasis added].  This alludes to the pitfalls of arguing against a regulatory authority’s inclusion of the cited personnel contributions as being part of the design team.

I tend to reflexively agree with some concerns/objections about inclusion of the QMS procedures as design documents requiring design team member attendance.  Yet if a regulatory authority wanted to really flex its muscles when push comes to shove, then I expect that it could also sustain an argument in some cases that authoring or release of QMS procedures to assure regulatory compliance could be part of the aforesaid regulatory design outputs (see my foregoing regulatory inputs/outputs explanations).  For example, remember that conformity with the EU MDR requires creation of QMS procedures according to the EU MDR.

March 2, 2023

Regulatory is Part of the Design and Design Team: Part 1

ISO 13485 demands that regulatory requirements be included in the required design inputs and outputs along with the corresponding verification (and maybe also validation depending on how a client approaches it). Consequently, the person who authored those regulatory design inputs, outputs, and/or verifications can’t be used as an independent reviewer of those design elements.

Although ISO 13485 doesn’t state a requirement for an independent reviewer, clients’ SOPs often do.  This is typically for addressing other jurisdictional requirements calling for an independent reviewer like those of the FDA.  If the SOP demands an independent reviewer and defines it in the usual way (i.e., as someone who doesn’t have direct responsibility for the stage/artifact being reviewed), then the team’s regulatory member who authored the regulatory inputs/outputs/verification is disqualified from being the independent reviewer of those artifacts.  Accordingly, a Notified Body (NB) nonconformity (NC) cited on this basis is in fact a valid NC.  In such a case, it can be necessary for an outside consultant/contract reviewer to be deployed for fulfilling the independent reviewer role.

On the topic of asserting that the regulatory team member is a part of the “project” team rather than the design team, the aforesaid ISO 13485 (and FDA) requirement for specific regulatory design inputs, outputs, verification, etc., precludes arguing that the person who authored those regulatory artifacts is a “project” team member rather than a design team member.  Such an argument will not hold up under scrutiny, as that notion conflicts with ISO 13485’s (and FDA’s) requirement for integration of regulatory requirements into the design requirements.

The person who authored the regulatory artifacts also cannot function as “other specialist personnel”.  This is because ISO 13485 requires that the design review team shall first include representatives of the functions concerned (i.e., the regulatory team member who authored the regulatory artifacts) as well as other specialist personnel.

In light of all this, I think one would be unsuccessful trying to argue against an NC asserting that Regulatory needs to be considered part of the design team rather than an independent reviewer, other specialist personnel, or just a “project” team member.  Instead, it would be better to find a sustainable solution(s) that will be within the boundaries I’ve laid out above.  For example, if a client has already hired three outside workers, then hiring another one on a limited basis for supporting design reviews should be within reason in my opinion.