Bradley Merrill Thompson Quoted in Article, “FDA Urged to Issue New Draft Guidance on Mobile Medical Apps”

The Gray Sheet

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "FDA Urged to Issue New Draft Guidance on Mobile Medical Apps," by Monica Hogan.

Following is an excerpt:

The mHealth Regulatory Coalition is asking FDA to release an update of its July 2011 draft guidance on mobile medical applications regulation, before it issues a final document, to give the public another opportunity to provide feedback on needed changes.

An ambiguous final guidance would leave mHealth technology developers "scratching their heads," says attorney Bradley Merrill Thompson.

FDA received "more than 500 pages" of feedback related to its July draft guidance document, wrote Bradley Merrill Thompson, an attorney for Epstein Becker & Green working on behalf of the mHealth Regulatory Coalition, in a Jan. 20 letter to CDRH Policy Advisor Bakul Patel.

After reviewing the comments, Thompson added, the coalition "strongly believes that the agency would need to make significant changes to adequately address the concerns that commenters raised."

According to Thompson, the public comments demonstrate a "meticulous effort" by a broad number of stakeholders to review and recommend changes to the FDA draft guidance. "These comments warrant an equally thorough review and proper consideration by the FDA," he adds.

"Prolonged use of vague enforcement discretion will perpetuate an uneven playing field, stifle innovation and suppress development where manufacturers who make an effort to comply with regulations are disadvantaged while others go to market in ignorance of the regulations," Thompson wrote. He called for the agency to publish a second draft guidance "as soon as possible to prevent continued uncertainty and unpredictability in the regulatory approach to mHealth technologies."