FDA Proposes Changes to Classification Rules for Combo Products

Regulatory NewsRegulatory News
| 14 May 2018 | By Michael Mezher 

The US Food and Drug Administration (FDA) on Monday proposed amending its product classification rules for combination products.

FDA says the proposed rule will help clarify the scope of the regulations, streamline the appeals process for product classification determinations and better align the regulations with recent legislation.

“We understand that regulatory uncertainty can stifle innovation as companies may avoid developing products. To promote the continued innovation of combination products, we want to make sure the process for classifying and assigning these products is clear and efficient,” said Thinh Nguyen, director of FDA’s Office of Combination Products.

The regulations, found in 21 CFR Part 3, were first promulgated in 1991 and were amended in 2005 to clarify the term “primary mode of action” as it applies to combination products.

According to FDA, the proposed rule will better explain what procedures apply to sponsors when the classification of their products is unclear or in dispute and make clear that requesting a designation for a product is only necessary when its regulatory classification is unclear.

But in comments to Focus, Bradley Merrill Thompson, a lawyer at Epstein Becker & Green and general counsel for the Combination Products Coalition, said he’s concerned about some of the provisions FDA is proposing to remove from the regulations.

Proposed Rule

One of the major changes presented in the proposed rule would be to remove an existing pathway for sponsors to request that FDA reconsider a product classification determination.

FDA calls the existing reconsideration process “confusing and inefficient” and says that such requests are unlikely to result in a different determination, as no new information may be included in the request.

Sponsors will still be able to challenge FDA’s product classification determinations by submitting supervisory appeals under 21 CFR 10.75.

Thompson called this move “particularly unusual,” and said that the request-for-reconsideration process can be valuable in situations where information in the initial request was overlooked without having to escalate an appeal to a supervisory level.

“The reason we like opportunities to request reconsideration is that sometimes a sponsor will find that the FDA—no matter how rigorous their process—simply overlooked a fact or misunderstood something in reaching its decision. So rather than go to a higher authority, the company can simply point out to the particular FDA office the mistake the particular office made,” Thompson said.

The proposed rule also clarifies that the procedures for requesting product classification only apply to sponsors and not to other entities, which FDA says have requested product classifications or assignments for products in the past.

By proposing that only product sponsors can request product classifications, Thompson said the agency is precluding industry from seeking broader classification determinations for new product types, such as software used with pharmaceuticals.

“There are certain issues that we would like to clarify for the entire industry. But this suggests that only a company can do it individually, and the output of it, by the way, will be confidential [and] not useful to others in the industry,” he said.

Federal Register, FDA


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