By Jennifer D. Newberger – On August 14, 2014, FDA issued a draft guidance titled, “De Novo Classification Process (Evaluation of Automatic Class III Designation)” (draft guidance). The de novo review process, formally known as Evaluation of Automatic Class III Designation, is established by section 513(f)(2) of …
By Jennifer D. Newberger — We previously posted about CDRH’s guidance on the appeals process contained in the Food and Drug Administration Safety and Innovation Act (FDASIA), and its issuance of a draft Q&A discussing section 517A. Section 517A imposed timeframes for appeal decisions that were …
By Allyson B. Mullen & Jeffrey N. Gibbs — On July 31, 2014, in accordance with Section 1143 of the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA notified Congress of its intent to issue two draft guidance documents regarding oversight of laboratory developed tests …
By Allyson B. Mullen — On July 28, 2014, FDA issued the final guidance document “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” The draft of this guidance was issued on December 27, 2011 (see our earlier blog post here). Very little has changed …
By Alexander J. Varond — FDA recently released its report entitled “Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases Including Strategic Plan: Accelerating the Development of Therapies for Pediatric Rare Diseases.” The report fulfills the …
By James E. Valentine* — On July 15, 2014, FDA announced the availability of a draft guidance, titled “Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors” (“FDA Draft Information Sheet”). When final, it will replace the Agency’s informed consent 1998 Information Sheet, “A Guide …
By Jeffrey N. Wasserstein – On July 2, 2014, five U.S. Senators sent a letter to the head of the Office of Management and Budget (“OMB”) urging OMB to release a draft guidance proposed by the U.S. Food and Drug Administration (“FDA”) relating to the regulation …
By Jamie K. Wolszon – In the past two months we have seen two newsworthy items in the Laboratory-Developed Test (“LDT”) world. In June, the Defense Health Agency (“DHA”) announced that TRICARE, the U.S. health care program serving Uniformed Service members, retirees and their families, has …
By Jennifer D. Newberger – Recognizing that even regulating certain software products as Class I medical devices is more regulation than necessary, FDA released a Draft Guidance document titled, “Medical Device Data Systems [MDDS], Medical Image Storage Devices, and Medical Image Communication Devices.” This Draft Guidance …
By Allyson B. Mullen – As part of the Medical Device User Fee Act of 2012 ("MDUFA III") Commitment Letter, FDA and the medical device industry agreed to participate in a comprehensive outside assessment of the medical device review process. The assessment was performed by Booz …
By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
By Allyson B. Mullen – On May 1, 2014, FDA issues a final version of the guidance document “Providing Information about Pediatric Uses of Medical Devices” (the “Final Guidance”). The draft of this guidance document was originally issued on February 19, 2013, at the same time …
By Jamie K. Wolszon – Earlier this month, FDA’s Center for Devices and Radiological Health (“CDRH”) announced a new voluntary “expedited access premarket approval (“PMA”) program” intended to speed development and approval of devices that treat or diagnose a life-threatening or debilitating disease and fulfill an …
By Allyson B. Mullen – On March 25, 2014, FDA issued a proposed rule amending the regulations for classification and reclassification to conform to the changes to the Federal Food, Drug, and Cosmetic Act (the Act) made by the Food and Drug Administrative Safety and Innovation …
By Allyson B. Mullen – On March 12, 2014, FDA issues a revised version of the Guidance Document “Administrative Procedures for CLIA Categorization” (the “2014 Guidance”). FDA, Guidance for Industry and FDA Staff, Administrative Procedures for CLIA Categorization (March 2014). The 2014 Guidance replaces the final …
