FDA’s Design Control Requirements for Medical Devices

Prepared by Kaiser J Aziz, Ph.D., Independent Consultant, EAS Consulting Group, LLC

20160725

FDA reviews, evaluates, verifies and validates the implementation of the design control requirements described in the device premarket applications (510k/ PMA). Design control requirements play a key role from the device design prototype, the manufacturing process to the finished device for user needs. Design controls are an integrated set of management practices and procedures which are applied to control design activities while assessing and maintaining device quality throughout the total product life cycle (TPLC).

Expect More Food Labeling Changes Now FDA has Finalized Its Nutrition Facts Regulations

FDA issued its final Nutrition Facts and Serving Size regulations last month, which in part were based on the new U.S. Dietary Guidelines for Americans (2015-2020).

However, those actions will not mark the end of new food labeling regulations issued by the agency. The food industry should brace itself for still more regulations that will align FDA’s nutrient content claims and health claims regulations with the new Nutrition Facts label and the new Dietary Guidelines. Some companies are looking forward to such changes to establish a level, competitive playing field while others fear new nutrition and health claim regulations will change the number and type of claims that currently can be made.

This matter was already raised by Dr. Stephen Ostroff, Deputy Commissioner for Foods, at a February 24, 2016, House Appropriations Subcommittee hearing on FDA’s FY ’17 budget. California Representative David Valadao (R) asked whether FDA would be updating the rules for nutrient content claims in light of the new Dietary Guidelines for Americans. The Congressman stated that, for example, some pastries can be labeled “healthy” while salmon, nuts, and avocados cannot.

This is because FDA’s current regulations governing the use of the term “healthy” require foods to be low in saturated and total fat, but do not adequately distinguish between other types of fats found in foods like salmon and nuts which newer evidence finds may be healthful.

Further, FDA’s definition of “healthy” does not take into account either total or added sugars content. That will almost certainly change now that FDA has finalized regulations requiring the disclosure of added sugars labeling on the Nutrition Facts label. In addition, FDA’s new Daily Reference Value (DRV) for added sugars means that the agency may create new nutrient content claims such as “low in added sugars.”

In addition:

  • Expect a new round of proposed regulations amending nutrient content claims such as “Low Fat,” “Low Cholesterol,” and “Lite.” The 2015-2020 Dietary Guidelines raise questions about existing FDA regulations for “low cholesterol” and “low fat” claims. The new Dietary Guidelines deemphasize the role of dietary cholesterol and put into question whether a “low cholesterol” claim would help consumers maintain healthy dietary practices. The new Dietary Guidelines also recognize that not all fats are the same – some can be part of a healthful dietary pattern. Accordingly, FDA may review whether an across the board “low fat” claim is still helpful to consumers and whether a “low cholesterol” claim should be discontinued.
  • FDA criteria for “lite” claims may be affected, as the definition of “lite” is intertwined with the definition of “low fat.”
  • Changes to nutrition claims like “low sodium” will also follow as FDA reduced the current DRV for sodium from 2400 mg to 2300 mg per day (although the agency has previously set special rules for “low sodium” claims given the difficulty food companies face in reducing sodium content).
  • A domino effect of changes in disclosure requirements (like “see back panel for nutrition information about _____”) that at times must accompany nutrition claims such as “High Calcium,” will likely be proposed as serving sizes for foods like ice cream have changed.
  • The new Dietary Guidelines may lead the agency to review its authorized health claim for total fat and cancer.

In short, after finalizing changes for the Nutrition Facts label on the backs of food packages, FDA will turn its attention to the fronts of the food package where the stakes on what the agency decides is permissible will be even higher. It is well accepted that nutrition information on the front of a food package attracts more consumer attention than information on the back. Expect FDA’s treatment of nutrition and health claims to be just as or more controversial as the changes the agency has made to the Nutrition Facts label.

Now is the time to plan ahead. EAS Consulting Group can generate nutrition profiles from databases, review revised labels and provide a customized analysis of how FDA’s new Nutrition Facts regulations may affect your company’s front label claims. Contact Cathryn Sacra at csacra@easconsultinggroup.com or call 571-477-5505 if you would like more information.