Our final newsletter of 2017 is packed with noteworthy links you may have missed, takes a look at the FDA's recently launched voluntary Medical Device Development Tools (MDDT) program, reviews the initiatives by the FDA to grow the generic medicine market for complex drugs, discusses the recent harmonization on specified micro-organisms, and concludes with a word from the President of Protocol Link, Steve Weltler.

Controlled Correspondence Related to Generic Drug Development (Draft Guidance)	Immunology and Microbiology Devices: Classification of the BCR-ABL Quantitation Test
FDA's Role in Medical Device Cybersecurity	Q4-FY 2017 MDUFA Performance Report
De Novo Classification Process (Evaluation of Automatic Class III Designation)	FDA Commissioner Scott Gottlieb's Keynote Speech at the 2017 Regulatory Convergence
Deciding When To Submit a 510(k) for a Change to an Existing Device	Updated FDA Manual Offers Inside Look at Inspection Protocols

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