US FDA 510(k) Regulatory Process Update

(Published July 2010)

We write to notify you of important changes affecting the US FDA’s 510(k) process; namely the Transparency Initiative and the issuance of the 21 Draft Proposals which are now open for Public Comment. It is our hope that in sending this correspondence, our clients will:

1. be made aware (if not already) of the changes circulating related to the FDA 510(k) regulatory process, and also,
2. to encourage the submission of comments to the FDA regarding the newly drafted proposals which will impact both US and foreign manufacturers in obtaining 510(k) clearance.

21 Proposals Open for Public Comment through 20 July 2010
In early 2009, the FDA announced the initiation of a new task force dedicated to improve the agency’s transparency. The Transparency Initiative , the FDA said, would be made in three phases. Phase I, FDA Basics, was launched in January 2010 with the emergence of an electronic resource, FDA Basics . Phase II, Public Disclosure, commenced on 21 May 2010 with the publication of the FDA Draft Proposals for Public Comment Regarding Disclosure Policies of the US Food and Drug Administration (more on Phase II below). And finally, Phase III, Transparency to Regulated Industry, as described in the Federal Register’s Notice of the Draft Proposals for Public Comment “will address ways FDA can become more transparent to regulated industry, to foster a more efficient and cost-effective regulatory process. The Task Force solicited comments from the public on this topic in March 2010… and draft proposals from this phase are expected in the summer of 2010.” Thus, as these proposals are released, we will be sure to communicate any important changes through another newsletter.

The deadline for when both mailed and electronically submitted comments must be received is 20 July 2010. The docket number which must be included with the comments is: Docket No. FDA–2009–N–0247, as listed in the Federal Register.

510(k) Process Revised
It is Emergo’s general position that the changes announced by the FDA will pose both challenges and opportunities to manufacturers.

Some of the likely implications of the changes recently discussed are that 510(k)s will become more cumbersome, require better research, better statistics, more accomplished dossiers, a general increased state of readiness in terms of QSR compliance even at the time of filing, and many more matters. Though the compilation of the 510(k) may become more difficult, we want to be explicit that the FDA has stated that they do not intend to dismantle or dissolve the 510(k) program. To this end, during a town hall meeting in Massachusetts, Dr. Jefferey Shuren, Director of the Center for Devices & Radiological Health (CDRH) commented: "The only thing I’m very clear about is we’re not recommending to get rid of the 510(k) program." Along these lines, an official FDA report on the 510(k) process and changes is anticipated to be made this summer.

Again, we highly recommend manufacturers review the 21 Draft Proposals , submit comments to the FDA, and attend Town Hall meetings. The FDA has already hosted two Town Hall meetings, one in Minnesota (May 18, 2010) and the abovementioned meeting in Massachusetts (held June 22, 2010). The next Town Hall meeting regarding the 510(k) process will be held in Los Angeles on October 7, 2010. We encourage those interested and who are located in or near Los Angeles, California to attend.

Should you have questions about any of the above, please do not hesitate to contact Emergo Group. We are fully equipped to assist with any of your global regulatory needs.

Best regards,

Evangeline Loh, PhD, RAC
Vice President of Regulatory Affairs

P.S. You might be interested in our easy to understand regulatory chart that explains the US FDA 510(k) clearance process , available as a free PDF download.