Wednesday, July 20, 2011

FDA proposes regulation of mobile apps

The FDA announced its proposed regulatory approach for mobile medical applications, or apps, designed for smart phones and other handheld devices.

In a draft proposal, the agency defines a small subset of mobile medical apps that affect or may affect the performance or functionality of currently regulated medical devices.  This subset includes mobile medical apps that:
  • Are used as an accessory to medical devices already regulated by the FDA (for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet); or
  • Transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices (for example, an application that turns a smartphone into an electrocardiogram machine to detect abnormal heart rhythms or determine whether a patient is experiencing a myocardial infarction). 

 The draft guidance excludes the following from regulation:
  • Mobile apps that are electronic "copies" of medical textbooks, teaching aids or reference materials, or are solely used to provide clinicians with training or reinforce training previously received.
  • Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition.
  • Mobile apps that only automate general office operations with functionalities that include billing, inventory, appointments, or insurance transactions.
  • Mobile apps that are generic aids that assist users but are not commercially marketed for a specific medical indication.
  • Mobile apps that perform the functionality of an electronic health record system or personal health record system.

The agency is seeking input from the public on its draft guidance.  Comments can be submitted for 90 days online or by writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The FDA will update the guidance based on feedback received.

Friday, July 8, 2011

FDA to Exempt Certain Diagnostic (IVD) and Radiology Devices from 510(k) Requirements

The FDA has issued a draft guidance that would exempt 30 different device typess from 510(k) clearance requirements. These devices include common urine and blood tests, alcohol breath tests, blood clotting protein tests and radiology device accessories.

According to the draft guidance, the in vitro diagnostic (IVD) and radiology devices have well-established safety and effectiveness profiles, so the FDA plans to use its enforcement discretion to exempt the device from premarket notification requirements as long as those devices “do not exceed the limitations on exemption specified in the device classification regulations.” In the future, the FDA also intends to reduce the pre-market regulatory burden on additional IVDs and radiology device types.

The FDA said it intends to continue to enforce all other applicable requirements for the devices, including, but not limited to, registration and listing and current good manufacturing practice regulations as set forth in the quality system regulations.

Tuesday, July 5, 2011

FDA Issues Draft Guidance On New Dietary Ingredients

The FDA announced today that it has issued draft guidance clarifying agency expectations on new dietary ingredients (NDI) for industry.  The guidance addresses in question-and-answer format what qualifies as an NDI ("a dietary ingredient that was not marketed in the United States before October 15, 1994"), when an NDI notification is necessary, the procedures for submitting an NDI notification, the types of data and information that the FDA recommends manufacturers and distributors consider when they evaluate the safety of a dietary supplement containing an NDI, and what should be included in an NDI notification.

Dietary supplement manufacturers are required to notify the FDA in advance when they intend to add a NDI to their products.  However, in certain situations when the ingredient has been part of the food supply (and is still considered an NDI), an NDI notification to the FDA is not required if it has not been chemically altered for use in supplements.

Under the guidance, minor loss of volatile components, dehydration, lyophilization, milling, and formation of a tincture or a solution in water, a slurry, a powder, or a solid in suspension do not chemically alter an ingredient.

However, the following are examples of processes that the FDA would consider to involve chemical alteration:
  • A process which makes or breaks chemical bonds such as hydrolysis or esterification, unless the bonds created by the process are reversed when the ingredient is dissolved in water (e.g., creation of a soluble salt) or during ingestion.
  • Removal of some components of a tincture or solution in water (e.g., by chromatography, distillation or membrane filtration), which changes the chemical composition of the mixture.
  • Use of solvents other than water or aqueous ethanol (tincture) to make an extract.
  • High temperature baking or cooking of an ingredient that has not previously been baked or cooked, unless the process causes only minor loss of volatile components with no other changes to the chemical composition of the ingredient.
  • Changing the manufacturing method for an ingredient such that the chemical composition is significantly different (e.g., changes that alter the composition of materials used to make the ingredient, use of a different solvent, use of a chromatographic matrix instead of a passive filter).
  • Application of nanotechnology that results in new or altered chemical properties of the ingredient.
  • Changing agricultural or fermentation conditions to alter the chemical composition of the ingredient, such as by sprouting garlic or fermenting yeast using a medium containing large amounts of sodium selenite to create large amounts of organic selenium compounds.
  • Fermentation using a fermentation medium different from the one used to make conventional foods in the food supply (e.g., use of a defined commercial growth medium to produce a microorganism previously made by fermenting milk into dairy products like yogurt or cheese).
  • Use of a botanical ingredient that is at a different life stage than previously used (e.g., making an extract from unripe instead of ripe apples or using the mycelium instead of the fruiting body of a fungus.)

The guidance also states that if the manufacturing process alter the chemical composition or structure of an "old" dietary ingredient, the resulting compound is probably an NDI and an NDI notification to the FDA would be required.  For example, using a solvent to prepare an extract from a "old" dietary ingredient creates a NDI because the final extract contains only a fractionated subset of the constituent substances in the original dietary ingredient.  In addition, changes that alter the composition of materials used to make the ingredient, such as using a different part of a plant (e.g., using an extract of plant leaves where the root extract from the same plant is an "old" dietary ingredient), would create a NDI.

The 53-page guidance document could greatly impact your business.  It is recommended that you read it carefully and discuss it with your legal and regulatory team. 

The FDA is inviting the public to submit comments about the draft guidance.  Although you can comment on any guidance at any time, to ensure that the agency considers your comments on the draft guidance before it begins work on the final version of the guidance, you should submit your comments by October 3, 2011.

For more information: Federal Register Notice for New Dietary Ingredient Notifications and Related Issues (link for submitting comments; Docket ID: FDA-2011-D-0376):!documentDetail;D=FDA-2011-D-0376-0001.