The consultant, the FDA and you

27 December 2023

mdi Consultants guides on how to make the best consultant choice, which is pivotal for the success and financial stability of any medical device manufacturing business.

Dealing with the FDA is not easy, especially for smaller companies who may not have experienced inhouse staff. Understanding what the FDA really means by time frames and due dates, knowing how to address regulatory concerns and preparing a response to a 483 or a warning letter requires an in-depth knowledge of regulations as well as the real life experience of dealing with the agency.

If an organisation cannot convince the FDA on what to expect and if they cannot meet the required compliance, the FDA will escalate their enforcement. In that case, the situation can quickly go from bad to worse; which is where consultants can bring the critical skill of negotiating on a client’s benefit.

Knowing which consultant to select can make the difference with the FDA. Just because a consultant understands the QSR/cGMP (21CFR820) does not mean they are experts in evaluating the FDA-483 observations and identifying appropriate corrective actions. Simply telling the FDA that observations will be addressed is not adequate, it wants to see that companies understand what their deficiency is, how to correct it and assure that corrective action is effectively implemented. A credible response to FDA must be based on precisely defined and implemented corrective actions, with supporting evidence collected and submitted to the agency.

Given the critical role that an outside consultant plays in their clients’ compliance, it is expected that a company does its due diligence and retains a consultant who has the expertise in dealing with FDA. The FDA QSR requires that consultants are qualified, just as all other vendors are supposed to be.

There are, in the FDA’s opinion, three types of consultants:

¦ The regulatory consultants who specialise in the 5l0(k) and PMA issues,

¦ Quality consultants who are adept at GMP auditing, writing and revising procedures,

¦ Technical consultants who know how to find problems and fix them.

¦ An ideal consultant has all three of the above qualifications.

While the FDA cannot recommend or endorse a particular consultant, its guide on selecting a consultant offers criteria to consider:

¦ How long has the consultant worked with the device (not drug GMP) regulations?

¦ Is their knowledge current?

¦ How does the consultant know CDRH’s current policies and interpretations are for device GMPs?

¦ Does the consultant sponsor or participate in training courses?

¦ Are they frequently asked to give presentations at FDA or industry sponsored seminars? What have been the reactions to these presentations?

¦ The consultant must be able to communicate problems and provide solutions in a clear, concise manner and in such a way that the company knows how to perform corrections the “right” way the first time.

¦ Has the consultant been deposed or testified as an expert witness either for the FDA or for industry?

¦ Obtain a list of the consultant’s clients over the last several years and check these references.

¦ What types of certifications does the consultant have? Are their certifications recognised by professional societies?

While these recommendations are logical, the need for such verifications has been accelerated by the red tape and regulatory environment that inflated the increased use of consultants.

When is a consultant needed is the most important question. An outside opinion on a difficult problem or an independent internal audit may be the first step to preventing a situation from getting out of hand.

Why is a consultant needed. If a company cannot realise a consultant is required in certain situations, it could cost more in the long run.

Who to hire is tantamount, both to assure the project is done correctly and that money is well spent. Consultants’ fees are usually related to their level of experience and the size of their support organisation.

There are reasons why people prefer the Hyatt to a Motel 6. The same theory applies to any type of service and especially consultants. Unfortunately, higher fees do not always assure quality work or that the required information is available.

A productive partnership

As the FDA recommends, checking references is important. How long has the consultant worked for the company and doing what kind of work? Is the consultant on a retainer agreement or would the company rehire them as needs require? Of course, consultants will tend to supply only the names of satisfied customers, but a truer picture of capabilities and qualifications emerges from references that cover several areas of consultation.

Good rapport is paramount to success. Both the business and the consultant must understand what is expected for the cost. There is no reason a consultant should not be able to estimate the cost of a project.

If it sounds too good to be true, it probably isn’t true. If a consultant promises anything overreaching regarding the FDA – for example, they could get a 510(k) reviewed in three months – it would be recommended to start looking elsewhere. The need for consultants does not appear to diminish any time soon. But the relationship need not be a one-sided affair to regret. A long-lasting relationship with a good consultant can be beneficial for both parties.

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