FDA Finalizes cGMP Rule for Drug-Device Combo Makers

The final rule clarifies which options manufacturers have to comply with the cGMPs applicable to their combination product, the FDA says, noting that “it will make it simpler and less burdensome for all manufacturers to apply the regulations when developing new products​...[and] could even shorten approval times for some products by reducing delays caused by lack of systems in place to comply with all applicable CGMP requirements​,” the FDA said.

Many of the cGMP requirements are facility specific, the FDA said, noting examples of product testing or controls over the supplies brought into the facility. Other non-facility-specific requirements “concern the product as a whole, such as design controls, and some concern overarching duties for the manufacturing process as a whole, such as Corrective and Preventive Action (CAPA) and management responsibility​.”

After receiving comments from 25 regulated entities, trade associations and individuals on the proposed rule, the FDA said it did not make any major changes to its proposal.

Several commenters noted that the proposed rule did not clearly address how it will apply to approved products already on the market. But the FDA said, “This rule does not create new CGMP requirements, but rather attempts to clarify how to apply them to combination products​.”

The FDA also rejected numerous suggestions from several commenters to revise and clarify the term “constituent part​,” arguing that its interpretation is important to understand the scope of the rule.

“The existing definitions appropriately characterize the components of drugs and devices, respectively, and we see no need to develop a distinct definition in relation to combination products​,” the FDA said.

In addition, several commenters called to delay the effective date of the new rule to one year after its publication, while others argued that the FDA has “substantially underestimated the costs of implementing this rule, and should extend the effective date in light of the greater costs​.”

But the agency snubbed those calls and said it will come into effect in late July. The FDA estimates that the final rule will have little substantial impact on the roughly 300 manufacturers of combination products, though some may incur one-time incremental costs and companies may need to devote 25 hours per product to bring them into compliance.

Further related guidance is forthcoming “on how to comply with this rule and the underlying regulations to which it refers, including with respect to coming into compliance with pre-manufacturing design control requirements for products currently being marketed,” ​the FDA said.