FDALegislativeWatch

Digital Mammography Firms Decry Clinical Trial Provisions In Draft Guidance

Digital mammography systems are on the verge of being downclassified to 510(k) status, but imaging firms say the clinical trial requirements proposed in FDA's draft "special controls" guidance for the systems are costly, unnecessary and overly burdensome.

Full-field digital mammography (FFDM) systems capture full digital x-ray images of the breast, and offer an alternative diagnostic and screening tool to conventional film screen mammography.

FDA Finalizing Guidance For Devices Containing Antimicrobial Agents

Revisions to a draft guidance on 510(k) submissions for devices or combination products that incorporate antimicrobial agents are awaiting final sign-off at FDA, an agency staffer said last week.

Industry is hoping for more clarity on FDA's definition of these products and for less burdensome data submission requirements than implied in the draft released in July 2007.

In recent years, FDA says it has been receiving more pre-market submissions for devices that are coated with or otherwise contain antimicrobial agents - a drug, chemical or other substance that kills or inhibits the growth of microorganisms.

Concerns about hospital-acquired infections have heightened clinicians' interest in these devices. C.R. Bard markets products such as the Agento IC silver-coated endotracheal tube, intended to reduce ventilator-associated pneumonia, and the Bardex IC infection-control coated Foley catheter. Baxter launched its 510(k)-cleared V-Link IV connector with VitalShield silver-based antimicrobial coating in April.

Manufacturers Negotiate With Japan For Higher User Fees To Speed Review

By April 1 of next year the number of medical device reviewers in Japan could increase dramatically via a substantial raise in industry-paid user fees.

"Intensive" negotiations to increase user fees and adopt changes that will speed Japan's approval process by streamlining regulatory procedures began July 7 between Japanese government officials and industry representatives including AdvaMed, according to Philip Agress, the U.S. trade association's vice president for global strategy and analysis.

The discussions are expected to continue throughout the summer, and the Japanese government has told industry that it hopes to reach an agreement by sometime in September at the latest, Agress said in an interview.

Device Pre-Market Review Times Dropped In ’06 and ’07

FDA has been getting faster at reviewing device pre-market submissions during the past two years, according to the Office of Device Evaluation 2006-2007 annual report.

In many cases, the reviews became quicker in terms of both the number of days an application is in FDA hands and the total elapsed time from filing to approval, the ¹report, released June 20, shows.

FDA received 9,276 major submissions in fiscal 2007, including 31 PMAs and 1,087 PMA supplements, and 9,415 submissions in fiscal 2006, including 25 PMAs and 1,113 PMA supplements.

ClinicalTrials.gov Requirements Continue To Baffle Firms And Feds Alike

Device companies are not the only ones tripped up by the new ClinicalTrials.gov trial registration requirements, as FDA, NIH and others struggle to define what is and is not subject to the law.

The source of the confusion: Title VIII of the FDA Amendments Act, enacted last September. This section of the 2007 law requires that certain drug and device trials be registered with the National Institutes of Health's ClinicalTrials.gov, include certain data elements in the listing and eventually include trial outcomes in a results database (¹"The Gray Sheet" Nov. 19, 2007, p. 8).

Registration of trials for some drug treatments has been required on the public database since 1997. Since 2004, trials were required to register in the public database in order to be published in an International Committee of Medical Journal Editors journal.

Regulatory Experts Note Wrinkles In FDA Accepting ISO 13485 Quality Audits

The idea of having a resource-starved FDA use internationally-accepted ISO 13485 audit reports in place of its own foreign facility inspections is gaining traction in Washington.

But FDA insiders, while not dismissing the idea, note that it is fraught with complications.

The FDA Amendments Act of 2007 directs FDA, for the purpose of setting risk-based inspection priorities, to accept voluntary submissions of International Organization of Standardization (ISO) quality system audit reports.

Device industry lobbyists now say FDA should go a step further.

House Democrats Hammer On Arguments Against FDA Pre-Emption

A Supreme Court ruling favoring federal pre-emption for PMA-approved devices will shift the financial burden of faulty devices from manufacturers to U.S. consumers and taxpayers, Congressional Democrats argue.

Reps. Frank Pallone, D-N.J., and Henry Waxman, D-Calif., recently floated a ¹draft bill that would undo the effect of the Feb. 20 Riegel decision by adding a provision to the 1976 Medical Device Amendments of the Food, Drug and Cosmetic Act entitled "No Effect On Liability Under State Law" (²"The Gray Sheet" March 24, 2008, p. 19).

During a May 14 Committee on Oversight and Government Reform hearing, the Democrats made a case for why Congress should overturn the Supreme Court's ruling in Riegel v. Medtronic and prevent a similar ruling in an upcoming case related to pharmaceutical manufacturers.

CMS Reconsiders Data Collection Requirements for Oncologic PET Scans

CMS will consider a request to lift its registry-enrollment requirements for positron emission tomography scans for certain cancers, the agency said April 10.

Creators of the National Oncologic PET Registry, formed in 2006, say they have collected enough data to support unfettered Medicare coverage of PET to diagnose, stage and uncover recurrences of brain, ovarian, pancreatic, small cell lung, prostate and other cancers.

Anxiety Over Prospects For Legislative 510(k) Reform Appears To Be Growing

FDA and industry are concerned Congress will revise the 510(k) process and defended the program and warned against statutory reforms during a panel discussion at the Food and Drug Law Institute annual meeting in Washington, D.C.

Heather Rosecrans, the acting head of the unit within FDA's Office of Device Evaluation that sets 510(k) and PMA policies, called the 510(k) process a "a well-oiled machine" and said during the March 26 session that there was no need for Congress to step in.

Reauthorized Bill Could Offer Bigger Grants To More Small MedTech Firms

The device industry and venture capital firms hope a House bill reauthorizing the Small Business Innovation and Research program will give more federal R&D funds to small firms regardless of their financial backing.

"One of the cornerstones of government investments in small medical technology companies has been the SBIR program," said Mark Leahey, executive director of the Medical Device Manufacturers Association (MDMA), at a March 13 House Small Business Committee hearing on the reauthorization bill.