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FDA to Evaluate Direct-to-Consumer Genetic Tests on Case-by-Case Basis

In an unusual departure from recent regulatory thinking, CDRH Office of In Vitro Diagnostics director Alberto Gutierrez said in March that FDA will determine on a case-by-case basis whether direct-to-consumer (DTC) genetic tests should be restricted and made available only through a doctor. Gutierrez spoke with reporters following a two-day meeting of the Molecular and Clinical Genetics Panel of the Medical Device Advisory Committee.

In an unusual departure from recent regulatory thinking, CDRH Office of In Vitro Diagnostics director Alberto Gutierrez said in March that FDA will determine on a case-by-case basis whether direct-to-consumer (DTC) genetic tests should be restricted and made available only through a doctor. Gutierrez spoke with reporters following a two-day meeting of the Molecular and Clinical Genetics Panel of the Medical Device Advisory Committee.

The long-running controversy about these lightly regulated, highly visible, DTC devices has drawn public warnings and hand-wringing from a variety of agency officials for several years. “We’re probably not going to be able to take one approach to all the types of tests that companies want to offer,” Gutierrez told reporters. “It depends on the disease and the type of test.” According to Gutierrez, some of the tests may be carefully regulated, with access to the tests and results limited to doctors.

Advisory-panel members cautioned that the tests could have unintended negative consequences, especially if users ill-equipped to correctly interpret the results fail to seek the advice of a doctor.

Last year, CDRH announced that it would move forward with a risk-based approach to providing regulatory oversight of the devices. The DTC tests received considerable attention in May 2010 when FDA objected to Pathway Genomics’ efforts to market an over-the-counter test collection kit through Walgreens drug stores because it was outside the boundaries of the regulatory safe harbor for such tests.

Jim Prutow, a partner at management consulting firm PRTM, says that the agency will likely require companies to develop products under regulated controls, file PMAs, and monitor complaints. He thinks companies are not prepared to handle these requirements.

“PRTM expects to see mandatory prescription as well as required genetic counseling for any tests that may result in a medical claim,” Prutow says. “There will likely be requirements for clinical data and premarket approval from FDA for tests that make medical claims.” Prutow says the resulting approval path will likely be time-consuming, delaying access to “cutting-edge genomic tests and information.”

“Unless balanced carefully,” he says, “the requirements could also impact the U.S. competitive position in the rapidly growing genomics field.”

Coming Soon: FDA Online Device Repository with Photos?

FDA is planning to develop an online repository of medical device labeling and a public database of device photographs. The agency will hold a meeting April 7 to discuss the idea. According to the meeting notice, such a repository could eventually include entries for all classes of devices. FDA intends to facilitate patient access to information on the types of devices that are available and how they can be used.

Also on FDA’s agenda is a preliminary staff recommendation that nonproprietary photos of cleared medical devices be made available in a public database.

The agency said it recognizes the sensitivity and potential confidentiality issues that could arise and wants feedback on the proposal. It is seeking comments on the guidance needed to ensure that the recommendation is implemented consistently and in a manner that is useful to the public without adversely affecting industry.

FDA Launches a Pro-Innovation Strategy

Ostensibly responding to a White House report titled, “Strategy for American Innovation: Securing Our Economic Growth and Prosperity,” but also surely heeding a rising chorus from the medical device industry, FDA commissioner Margaret Hamburg announced in March that an internal team will develop an innovation strategy for the agency.

The effort, she said, will be led by Vicki Seyfert-Margolis, from the FDA Office of the Chief Scientist, and Maureen Byrnes, a former Hamburg colleague who has worked in Washington, D.C., has served as executive director of the National Commission on AIDS, and has been the director of health and human services programs for the Pew Charitable Trusts.

Hamburg said that developing an FDA innovation strategy requires the participation and input of all centers and offices. Center directors are each being asked to appoint a senior level representative to serve on the team.

“I am excited about the role FDA can continue to play in driving innovation that will improve the health and well-being of all Americans,” Hamburg concluded.

Letter Outlines Why FDA Denied PMA for Ethicon’s Sedasys

CDRH has released the letter it sent to Ethicon Endo-Surgery in October denying a PMA for the Sedasys computer-assisted personal-sedation system. The release comes as the company’s appeal is being reviewed by the agency.  The letter paints a picture of CDRH offering to work with the company to make the PMA acceptable and the company rejecting those overtures in favor of an administrative appeal.

In denying the PMA application, the letter says the company failed to demonstrate that the system’s possible benefits outweigh any probable risks, considering the system’s intended use and conditions of use when accompanied by adequate directions.

Ethicon is seeking an indication for the intravenous administration of 1% propofol injectable emulsion to initiate and maintain minimal-to-moderate sedation in adults undergoing colonoscopy and esophagogastroduodenoscopy procedures. The intent is to provide a means by which gastroenterologists and their nurses can administer sedation for the specified procedures.

According to the letter, CDRH determined in February 2010 that the PMA was not approvable because the submitted evidence did not sufficiently demonstrate a reasonable assurance of the device’s safety under labeling conditions. The company responded by requesting an administrative review of the decision. It canceled a planned after-action meeting to discuss the nonapprovable letter.

CDRH said it wrote the company last October proposing that it submit a PMA amendment addressing issues that the agency identified, but Ethicon rejected that proposal two weeks later. CDRH identified several reasons for denying the PMA application.

First, the system would expand the population of healthcare officials who administer propofol, representing a departure from currently approved labeling. According to CDRH, however, the pivotal study data did not provide enough evidence that propofol could be safely administered with the system to justify such a departure. CDRH said that because of the way the trial was conducted, it couldn’t evaluate the distinct risks involved in administering propofol using the Sedasys system compared with administering the sedative according to its current approved labeling. It also said that because Sedasys was associated with an increased incidence of deeper-than-intended sedation, including episodes of general anesthesia, the study appeared to indicate that the warning on the current propofol labeling remains necessary and relevant when the sedative is administered with the system.

Second, the company’s proposal to implement a targeted training program to mitigate the risks associated with deeper-than-intended sedation was deemed inadequate, because the company had not conducted an outcome-based clinical study to enable evaluation of the proposed training.

Third, CDRH said it had no reason to believe that the company’s proposal to augment the skills of mild-to-moderate sedation providers would be sufficient, because those providers would be expected to manage general anesthesia when using the system. The letter said the proposed instruction in endotracheal intubation was minimal, and CDRH expressed concern that patients would face an unnecessarily increased risk of airway trauma.

In 2009, members of FDA’s Anesthesiology and Respiratory Therapy Devices Advisory Committee voted 8–2 to recommend approving Sedasys. The group stipulated that the system should only be used on adult patients under the age of 70, that users should undergo a comprehensive training program, that the sedation delivery team should be defined, and that a post approval study should be conducted.

Class 1 and 2 Devices Must Continue MDR Filings

In March, FDA clarified that device manufacturers and importers of all devices must continue to submit malfunction reports, as mandated by the agency’s medical device reporting regulation, until further notice. 

In a new notice, the agency explained that the 2007 FDA Amendments Act changed malfunction-reporting requirements for Class 1 devices and those Class 2 devices that are not permanently implantable, life supporting, or life sustaining. The agency is required to notify affected device makers that their device requires malfunction reporting. 

The agency said it intends to provide further notice in the Federal Register, which lists the types of affected devices that should be subject to the amended reporting requirements. In the meantime, FDA says it is necessary to subject all such devices to the reporting requirements, until the specific notice identifying the affected devices is published.

FDA Asks Makers of Denture Adhesive to Assess Zinc Risks

FDA says it has received numerous reports of adverse events related to the use of denture adhesives. It is asking denture adhesive manufacturers to address the risks associated with the use of zinc in the products. “Although zinc is an essential nutrient, overexposure may result in zinc toxicity,” said a recent FDA letter to the manufacturers.

The agency identified the population most at risk as those who use excessive amounts of denture adhesive over extended periods of time, as well as those with poor-fitting dentures and those who are unable to read or understand product labeling.

FDA asked manufacturers to take the following steps:

  • Perform a labeling risk analysis to assess how risks can be mitigated.
  • Conduct a human factors study to assess consumer understanding of labeling and the potential for product misuse.
  • Modify labeling to include a statement that the product contains zinc, if appropriate, and define the maximum safe usage in easily understood terms.
  • Replace zinc with an ingredient that presents fewer health risks when overused.

If the substitute ingredient results in a new formulation, the agency wants manufacturers to submit a new 510(k).

FDA Forces ‘Misleading’ Implant Info from Web

Consumer advocacy organization Public Citizen has lauded FDA for its “action [in] prompting two leading plastic surgery associations to remove misleading information regarding breast implant-related cancer from the organizations’ Web sites.” Public Citizen had contacted FDA in February to report that the presidents of the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery were urging their members to inaccurately downplay the significance of recent evidence regarding breast implant-related cancer risks when speaking to female patients. The comments in question were made during a webinar posted on the associations’ Web sites.

Public Citizen released a letter from CDRH director Jeffrey Shuren indicating that after FDA reviewed the webinar and spoke with representatives of both organizations, the groups agreed to take the webinar down.

According to Public Citizen, the webinar featured claims that the type of cancer seen in breast-implant patients had a “benign course,” and that “surgery [to treat the cancer] was curative.” In his letter, Shuren said that FDA believes “the optimal treatment regimen for breast implant-associated anaplastic large cell lymphoma has not been established and … additional data collection is needed to fully understand … [its] risk factors, optimal treatment plan, and prognosis.” 

Shuren also reported that the ASPS and other experts in the clinical and scientific communities have agreed to work with FDA to develop a registry to gather additional information about anaplastic large cell lymphoma in women with breast implants.

Maker of Chinese Test Kit Cited for QSR Violations

An FDA inspection last September at Abon Biopharm’s rapid test-kit manufacturing facility in Hangzhou, China, found violations of CDRH’s Quality System Regulation, according to a recently released warning letter that the company received in December. The letter says that violations cited on the FDA-483 included:

  • Failure to adequately ensure that, when the results of a process cannot be fully verified by subsequent inspection and testing, the process is validated with a high degree of assurance and approved according to established procedures.
  • Failure to establish and maintain procedures to ensure that sampling methods are adequate for their intended use, and to ensure that when changes occur, the sampling plans are reviewed.


The letter says FDA could not determine the adequacy of the firm’s response because it provided insufficient information.
The company was told to take prompt action to correct the violations and to submit a list of specific steps that have been taken, with documentation of the actions and a timetable for completion.

FDA Says Medtronic’s Amplify is Not Approvable

Medtronic recently reported that it had been advised by FDA that its Amplify bone-graft product is not approvable without
additional information. The company said in an SEC filing that it is in active discussions with the agency and has been given an opportunity to provide additional information. Medtronic is continuing to seek FDA marketing approval for Amplify for an indication for single-level, posterolateral spinal fusion procedures in patients with degenerative disc disease.

Earlier this year, FDA’s Orthopedic and Rehabilitation Devices Advisory Panel said there was reasonable assurance that the Amplify matrix is safe and effective for the proposed indication and that the benefits outweigh the risks.

Cordis Plant in Puerto Rico Cited for QSR Violations

An FDA inspection last October at a Cordis manufacturing facility for interventional cardiovascular devices in San Germán, Puerto Rico, found violations of the QSR. According to a February 16 warning letter from FDA’s district office in San Juan, specific violations included:

  • Failure of the company’s corrective and preventive action plan to correct and prevent nonconforming products.
  • Failure of the firm’s process control procedures to ensure that a device conforms to its specifications.


The letter says the company should take prompt action to correct the violations and to submit a list of the steps taken with documentation and a timetable for completion.

Guidance on Urinary Incontinence Device Studies

FDA has issued a guidance on devices that are used to treat urinary incontinence. Titled, “Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence,” the guidance gives recommendations for clinical investigations of such devices.

The guidance says that the ultimate goal of such investigations is to design a study using objective, unbiased outcomes to measure the device’s safety and effectiveness. Designing and conducting such studies presents many difficulties, according to the guidance, due to challenges posed by the condition and the patient population.

The guidance includes an introduction and specifies scope, clinical indications, pilot study recommendations, and pivotal study recommendations.

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