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even regulating certain software products as Class I medical devices is more regulation than necessary, FDA released a Draft Guidance document titled, “Medical Device Data Systems [MDDS], Medical Image Storage Devices, and Medical Image Communication Devices.” This Draft Guidance …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 …
By Allyson B. Mullen – On February 18, 2014, the FDA issued the Final Guidance “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” (the “Pre-Sub Guidance”). FDA, Guidance for Industry and FDA Staff, Requests for Feedback …
By Allyson B. Mullen & Jeffrey N. Gibbs – The end of 2013 marked the first anniversary of CDRH’s Refuse to Accept Policy for 510(k)s (the “RTA”). FDA, Guidance for Industry and FDA Staff, Refuse to Accept Policy for 510(k)s (December 2012). Therefore, we thought it …
By James C. Shehan – Vermont law has banned manufacturers of prescription drug, device, and biologics products from providing most gifts to physicians and other healthcare professionals since 2009 and has required these manufacturers to report permitted gifts and payments to Vermont HCPs since 2002 (summarized …
By Allyson B. Mullen – On February 14, 2014, FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit MDRs in an electronic format (the “Final Rule”). 79 Fed. Reg. 8832 (Feb. 14, 2014). …
By Jennifer D. Newberger – On February 5, 2014, CDRH released its 2014-2015 Strategic Priorities, in which it stated that the most important areas of focus over the next two years will be to “strengthen the clinical trials enterprise,” “strike the right balance between premarket and …
At the Food and Drug Law Institute’s (“FDLI’s”) 2014 Medical Device Conference – Key Legal and Regulatory Developments, which will take place in Washington, D.C. on February 27, 2014, top FDA officials will discuss their most significant recent activities and forecast upcoming medical device activities. …
By Jeffrey K. Shapiro – FDA has issued a new draft guidance on the custom device exemption. Comments are due by March 17, 2014. This schedule puts FDA on track to finalize the guidance by July 9, 2014, as required under section 617 of the Food and …
By Jennifer D. Newberger – On January 10, 2014, FDA issued a final rule amending the PMA regulations to require inclusion of information relating to pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure, and the …
