Last week, the FDA issued a final rule(1-2) on combination products(3) and the applicable current good manufacturing practice (CGMP) requirements. The final rule actualizes the proposed rule that was issued many moons ago, in September 2009 without significant changes. Four sections comprise the final rule(1-2); §4.1 - Scope, §4.2 - Definitions, §4.3 - Applicable CGMPs, and §4.4 - Single-entity or co-packaged combination products compliance with these requirements.
One of the major take home points from the final rule is that manufacturers have the ability to choose which pathway to primarily follow, as long as they incorporate the unique features applicable to their combination product. For example, a pharmaceutical company that has a combination product, would be responsible for following design controls from the device GMPs, in addition to their standard pharmaceutical GMPs.
The final rule becomes effective 22 July 2013.
(1) FDA. Current Good Manufacturing Practice Requirements for Combination Products, Final Rule 78 Fed. Reg. 4307-23. (22 Jan. 2013) (to be codified at 21 C.F.R. pt.4). Print. Available at: https://www.federalregister.gov/articles/2013/01/22/2013-01068/current-good-manufacturing-practice-requirements-for-combination-products. Accessed on 28 Jan. 2013.
(2) FDA. Federal Register. 78(14). http://www.gpo.gov/fdsys/pkg/FR-2013-01-22/pdf/2013-01068.pdf. Accessed on 29 Jan. 2013.
(3) FDA. Code of Federal Regulations. Available at: http://www.gpo.gov/fdsys/pkg/CFR-2012-title21-vol1/xml/CFR-2012-title21-vol1-part3.xml. Accessed on 29 Jan. 2013..