Medical Devices

A Long Overdue Revision to the Intended Use RegulationOctober 18th, 2015
By Jeffrey K. Shapiro – A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply. The intended use of …
Back from Break: FDA Issues Letter to Pathway Genomics for Cancer Screening LDT; Proposed Legislative Alternatives to FDA Framework Continue to EmergeSeptember 29th, 2015
By Jamie K. Wolszon & Jeffrey N. Gibbs – As kids around the country return to school, FDA also appears to be returning from a break—in this case a break from public enforcement-type activities related to laboratory-developed tests (LDTs)—with the issuance of a letter to Pathway …
Velvet Ropes Can’t Stop the FDA: Effort to Defeat FDA Jurisdiction Based on Club Membership Is Unceremoniously BouncedSeptember 2nd, 2015
By James C. Shehan & Andrew J. Hull – The U.S. Court of Appeals for the Eighth Circuit recently issued an opinion in the case of Lytle v. U.S. Department of Health and Human Services, Nos. 14-3715, 15-1214 (8th Cir. Aug. 21, 2015), affirming that private membership …
Molecular Pathologist Group Proposes Legislative Solution to Modernize CLIA, Including CMS/Third-Party Premarket Review, as Substitute for FDA’s LDT FrameworkAugust 14th, 2015
By Jamie K. Wolszon – As we have previously blogged on numerous occasions, FDA has released a framework for regulation of laboratory-developed tests (LDTs) that has sparked considerable controversy. The Association of Molecular Pathology (AMP), which represents molecular pathologists and has been an active participant in …
Combination Products Reform Bill Is A Good Start, But Its Provisions Need StrengtheningAugust 6th, 2015
By Jeffrey K. Shapiro & Jeffrey N. Gibbs – The Office of Combination Products (OCP) was established in 2002 to improve the agency’s handling of combination products and also drug versus device classification decisions. Unfortunately, it has become clear that more needs to be done. FDA’s …
Senate and House Lawmakers Add to FDA’s To-Do List in Fiscal Year 2016 Appropriations BillsJuly 24th, 2015
By Kurt R. Karst – Earlier this month, legislation was introduced in both the U.S. Senate and U.S. House of Representatives to fund FDA for the next fiscal year: Fiscal Year 2016. Both the Senate bill and the House bill, titled “Agriculture, Rural Development, Food and …
Not All Devices are Created Equal: UDI Direct MarkingJune 29th, 2015
By Jennifer D. Newberger – Devices intended to be reprocessed and used on more than one patient are required to be directly marked with a unique device identifier (UDI). 21 C.F.R. § 801.45. If, however, the direct marking “would interfere with the safety or effectiveness of the …
FDA to Weigh Risks and Benefits in Approving Investigational Device ExemptionsJune 23rd, 2015
By Jennifer D. Newberger – To further its efforts to balance risks and benefits with respect to approving medical devices through the premarket approval (PMA) pathway or utilizing the de novo classification process, FDA has now issued a draft guidance, "Factors to Consider When Making Benefit-Risk …
Enforcing The “Least Burdensome” Requirement for Premarket Review of DevicesJune 22nd, 2015
By Jeffrey K. Shapiro – Last week, Senators Richard Burr and Al Franken introduced legislation aimed at easing the burdens of the Food and Drug Administration’s (FDA) review of devices. The bill is called “The FDA Device Accountability Act” (FDAA). A copy of the press …
Federal Courts Erroneously Continue to Claim that FDA Only Spends 20 Hours On Average Reviewing 510(k)sJune 10th, 2015
By Jeffrey K. Shapiro – In 1987, an FDA official testified that 20 hours were spent on average to review a 510(k) submission. Hearings before the Subcommittee on Health and the Environment of the House Committee on Energy & Commerce, 100th Cong., 1st Sess. (Ser. No. …
Avalanche! Congress is Buried Under a Slew of FDA-Related Legislation as the 21st Century Cures Act Makes Its Official DebutMay 20th, 2015
By Kurt R. Karst – On May 19th, the House Committee on Energy and Commerce took up consideration of the 21st Century Cures Act. The bill, H.R. 6, is a 309-page behemoth that was officially introduced on May 19th, and is the fourth iteration of the …
FDA Issues Draft Guidance Regarding Patient Preference Information for Medical Device SubmissionsMay 17th, 2015
By Jennifer D. Newberger – In March 2012, FDA issued a guidance document, Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications. As we discussed in our blog post on that guidance, one important discussion in that guidance had …
FDA Announces Progress Regarding Balancing Premarket and Postmarket Data Collection for PMAsMay 1st, 2015
By Jennifer D. Newberger – As part of its 2014-2015 Strategic Priorities, the Center for Devices and Radiological Health (CDRH) committed to assuring the “appropriate balance between premarket and postmarket data collection to facilitate and expedite the development and review of medical devices.” By December 31, …
FDA Releases Draft Guidance Regarding Use of OUS Clinical Data in Device SubmissionsApril 24th, 2015
By Allyson B. Mullen – On April 22, 2015, FDA released a draft guidance regarding use of clinical data generated outside of the U.S. (OUS) in medical device premarket submissions. A copy of the draft guidance can be found here. FDA states in the guidance that it …
Diagnostic Test Working Group Proposes Alternative to FDA’s LDT FrameworkApril 16th, 2015
By Allyson B. Mullen & Jeff N. Gibbs – As we have previously blogged on numerous times (for example, here and here), FDA has released a framework for regulation of laboratory developed tests (LDTs). FDA’s proposed framework has sparked much controversy, receiving support from diagnostic test …

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