Blog Tag: FDA
In a speech in Cambridge on December 11, 2014 (which was reported on in an article in the Boston Business Journal), Dr. Bill Maisel– the science chief of the U.S. Food and Drug Administration’s center to oversee approval of medical devices – addressed long-standing complaints that the time to approve trials and new devices was too long.
According to the Boston Business Journal, Maisel spoke before members of MassMEDIC, Boston’s advocacy group for the medical device industry, and his speech was part of a daylong FDA Update event intended to give an overview on hot topics in regulatory approval in 2015.
The article reported that the FDA is on track to “meet or exceed” its own deadlines for approval and has worked in the past 2-3 years to cut half of its backlog of applications. As for the coming year, Maisel was quoted as stating that his priority is “strengthening the clinical trial enterprise.”
The article also stated that the FDA has cut down the average length of time of the submission of an application to conduct a clinical trial to decision by 75% in the past three years (from an average of 400 days to 2011 to 101 days this year).
According to the article, Maisel also remarked that the FDA was taking other steps to expedite approvals including:
- reviewing categories of devices considered high-risk to see if any of them can be downgraded; and
- the possibility of an “Expedited Access PMA” program – an accelerated approval program for companies developing products designated as high risk but in areas with significant needs.
More information for the FDA’s Monthly PMA (Premarket Approval)/PDP (Product Development Protocol) Decisions and Summary Statistics can be found here.
On August 29, 2014, the FDA issued 233 Class I medical device recalls for products manufactured by Customed. According to its website, Puerto Rico-based Customed is a medical supplies leader and distributes a wide range of products to many hospitals and thousands of doctors’ offices, hospices, laboratories, radiology centers, pharmacies and other healthcare facilities.
According to the FDA’s website, Customed voluntarily recalled the 233 devices due to packaging flaws. The devices recalled include various medical and surgical packs (e.g., laparotomy pack, femoral pack, labor & delivery pack, open heart tray pack, etc.), all having sterile packaging. The device supplier stated in a recent press release that the sterile convenience surgical packs were found to have potential defects in packaging adhesion that could result in a loss of product sterility and subsequent patient infection. The Regulatory Affairs Professionals Society (RAPS) estimates the number of affected units to be several hundred thousand. As of August 21, 2014, no serious injuries or deaths were reported.
According to the FDA’s website, medical device recalls remove a product from the market and may be conducted on a company’s own initiative, by FDA request, or by FDA order under statutory authority (21 CFR § 810.1 et seq.). To reflect varying severity of risk presented by different devices being recalled, FDA recalls are categorized as Class I, Class II, or Class III. Those classes are defined as follows:
Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
RAPS reports that, aside from a few statistical outliers, the overwhelming majority of all FDA medical device recalls are either Class II or Class III recalls (reflecting “lesser (and non-deadly)” safety risks). In fact, since 2004, Class I, Class II, and Class III recalls comprised 6%, 86%, and 7% of total recalls, respectively. While the FDA typically recalls 13-75 devices daily, RAPS reports that there have historically been relatively few major device recalls despite an overall upswing in the number of recall events since 2012.
According to RAPS, the Customed device recall represents the single largest FDA recall to date, regardless of class, and is more than 9 times larger than the second largest Class I recall (which occurred on March 5, 2014).
There seems to be a mobile app for just about everything now. Among the multitude of apps available are an increasing number of medical apps. In response to this growing trend, the FDA has issued a final guidance document for developers of mobile medical apps. The guidance explains that the FDA plans to limit its scrutiny to apps that transform a mobile device into a regulated medical device or are intended to be used as an accessory to a regulated medical device because these types of apps could be harmful if they don’t function properly.
The final document follows a draft issued in July 2011 that received more than 130 comments. In response to comments seeking more clarity, the FDA included in the final version more examples of what the agency does and does not intend to regulate. According to the guidance document, examples of apps that will be the subject of oversight include apps that calculate the amount of radiation to be given to a cancer patient and apps that control inflation and deflation of a blood pressure cuff. The guidance indicates that these types of apps essentially perform the functions of traditional medical devices, and notes that the FDA will regulate them as it does traditional devices.
According to the guidance document, the agency plans to leave low-risk apps alone, even those that might fall under the definition of a medical device. For example, apps that allow doctors or patients to log blood pressure readings or diet related apps that recommend the number of calories a person should consume may not be scrutinized. The guidance document also clarifies that providers of medical apps, for example, the iTunes app store, will not be treated as medical device manufacturers.