Changes to existing medical devices 510 (k) guidelines – has the FDA gone too far?
Significant advances in technology have occurred since the FDA released guidance on changes to an existing medical device in 1997. It seems logical that the FDA would want to update its current thinking. However, there was a groundswell of criticism, upon the release of draft guidance in 2011 – resulting in the FDA’s rescission of its updated guidance pending further review by Congress.
FDA is due to issue a report to Congress, no later than January 2014. In its report, the FDA is required to explain how it will determine when a 510(k) is need for a change to an existing medical device. In addition, they must explain how they plan to maintain effective oversight while also allowing industry the freedom to innovate.
AdvaMed has expressed its opinion. As I understand, they feel that the FDA’s concerns can be addressed through a few ‘targeted improvements’ (or rather explicit requirements) added to the 1997 guidance as follows: (As EXCERPTED from page 16 of AdvaMed’s white paper released on June 11, 2013: MODIFICATIONS TO CLEARED DEVICES IN COMMERCIAL DISTRIBUTION: DETERMINATION OF THE NEED FOR ADDITIONAL 510(k) PREMARKET NOTIFICATION)
- An explicit requirement in the guidance document that when a change is made to a specification, method, or procedure, each manufacturer should evaluate the change in accordance with an established procedure to determine if the submission of a premarket notification is required, and to require the retention of records of this evaluation and its results.
- An explicit requirement in the guidance document for each manufacturer to establish a procedure within its quality system to ensure that after the design requirements are established and approved, changes to the design, both preproduction and post-production are also reviewed, validated (or verified where appropriate), and approved.
- Explicit statements at every stage of the guidance document that the responses to each question in the decision trees must be made based on the results of validation testing (or verification testing, where applicable) undertaken in compliance with the requirements of 21 CFR 820. This would provide assurance to the Agency that the questions in the 1997 guidance document are not being arbitrarily answered; rather, that they are being addressed through an FDA-sanctioned process and documented accordingly.
In my opinion, you can’t make explicit requirements without going through a formal process under the Federal Food Drug and Cosmetic Act, (as amended). An explicit requirement in a guidance document doesn’t fall under the general guidance document umbrella. Moreover, a guideline is not enforceable under the law.
I agree that manufacturers are in a better position than the FDA to decide on what constitutes a substantial change or modification to the intended use of a device initially. Manufacturers must exercise caution, however, as problems may arise concerning the proper risk assessment analysis, documentation and procedures for the change or modification. In addition, device manufacturers may expose themselves to additional risk if later the manufacturer and the FDA disagree on the device’s marketing status.
As I understand it, AdvaMed’s chief concerns relate to Class I and II medical devices as well as the need for a more clear definition of what constitutes a “significant change”. For Class I and II devices, I agree with AdvaMed’s intended proposed changes to the current 1997 guidance. However, as I expressed above; they can’t simply be expressed as requirements in a guidance document. I also agree with AdvaMed’s position that the current 1997 guidelines don’t impede the FDA from finding violations and taking appropriate enforcement action.
However, Class III implantable devices offer the highest degree of risk to patients and are the most cited in recalls. There are certain advocacy groups such as the Consumer’s Union who believe that all Cass III implantable devices should be regulated as a PMA and not as a 510 (k) when making “significant changes” or modifications.
The rescinded 2011 FDA guidelines were proposed as a preventive action to help minimize the risk of serious injuries to the patient, a common goal of both the manufacturer and the FDA. FDA actions may slow some of the changes that manufacturers may propose before marketing, but that should help the esteem of the industry and not harm it by working together.
One final thought – neither the existing guidelines on when to submit a 510 (k), nor the rescinded draft guidelines mention combination device products. The FDA needs to also address how to handle those products.
About the Author:
Jim Hamilton is a former FDA compliance officer with over 25 years of experience with the FDA and 10 years in private industry. He is the CEO and Co-Founder of the quality & compliance consulting firm JE Hamilton & Associates and is a member of AZBIO.