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Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "FDA Urged to Issue New Draft Guidance on Mobile Medical Apps," by Monica Hogan.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The mHealth Regulatory Coalition is asking FDA to release an update of its July 2011 draft guidance on mobile medical applications regulation, before it issues a final document, to give the public another opportunity to provide feedback on needed changes.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FDA received "more than 500 pages" of feedback related to its July draft guidance document, wrote Bradley Merrill Thompson, an attorney for Epstein Becker & Green working on behalf of the mHealth Regulatory Coalition, in a Jan. 20 letter to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comments demonstrate a "meticulous effort" by a broad number of stakeholders to review and recommend changes to the FDA draft guidance.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 He called for the agency to publish a second draft guidance "as soon as possible to prevent continued uncertainty and unpredictability in the regulatory approach to mHealth technologies."

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.