Mark’s Memo: FDA Updates and News Briefs | 03/31/10

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Mark Mansour, Partner, Bryan Cave, LLP

Mark Mansour, Partner, Bryan Cave, LLP

Industry Submits Comments on 510(k) Review, Use of DeNovo Process

Reports are predicting that, as the FDA considers changes to its 510(k) review process, it will face difficulties in expanding or creating a vehicle for the review of novel medical devices without requiring those technologies to go through the more cumbersome premarket approval process. Although some industry groups have called for the increased use of the DeNovo process for novel technologies, industry experts are indicating that the use of that avenue is complicated by a lack of resources and by the requirement that the FDA develop specific guidance documents for each approved device, a process that consumes agency resources and may make the agency more hesitant to such expansion.

Others are also submitting comments on the 510(k) review process, as it undergoes reevaluation from the FDA. Comments include that the database requiring manufacturers to enter exact keywords to locate a predicate device is ineffective. In addition, industry has submitted comments regarding whether the FDA should have rescission authority for its 510(k) substantial equivalence decisions. Industry lobbyists have commented that such rescission authority should be limited to extreme cases of fraud. These groups state that the agency can make use of other means to remove problematic devices from the market, such as banning the product, mandating a recall, or ordering a product seizure.

FDA Amends Public Hearing Regulations

The FDA is amending its regulations on public hearings before public advisory committees to reflect an internal change with respect to the staff that handles the nomination and selection process for nonvoting members representing consumer interests for standing technical advisory committees. The FDA is also revising the address where the nominations for nonvoting members representing consumer interests should be submitted. For more information click here.

FDA Proposes Amendments to DTC Advertising Regulations

The FDA is proposing to amend its regulations concerning direct-to-consumer (DTC) advertisements of prescription drugs. Specifically, the proposed rule would implement a new requirement of the Federal Food, Drug, and Cosmetic Act, added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that the major statement in DTC television or radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. Written comments are due by June 28, 2010. For more information click here.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

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