February 2019 – FDA News

PREMARKET NOTIFICATION 510(K)

A 510(k) or Premarket Notification is the technical document required by the FDA to prove that the device to be marketed in the United States are as safe and effective, that is, substantially equivalent, to a legally marketed device which is not subject to PMA. A person who apply for 510K clearance must compare their device to similar legally marketed devices and create and support their substantial equivalence claims. The legally marketed devices to which uniformity is drawn is known as “Predicate”.

The Submitter cannot market the device until he receives an order from FDA declaring a device substantially equivalent (SE). Once the device is declared as SE, it can be legally marketed in United States. SE determination will be made within 90 days of submission and also based on the information submitted by the submitter. Substantial equivalence is issued with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics of the device. If FDA found out that the device is not substantially equivalent (SE), the submitter has to resubmit another 510K with new information or request a product classification via De Nova Classification process or to submit a premarket approval application (PMA).

Who needs to submit a 510K

The following are the four categories of 510K submitters to the FDA.

Domestic manufacturers who introduce a new device to the U.S market. However only finished device manufacturers who manufacture device according to their own specifications needs to submit 510K, whereas the contract manufacturers are not required to submit a 510K.
Specification developers are required to submit a 510K but not the contract manufacturers.
Re-packers or Re-labelers may be required to submit 510K if they change the labels or any other operations that affect the condition of the device.
Foreign manufacturers/exporters who introduce a new device to the U.S market.

All manufacturers, specification developers of Class II and Class III devices and certain Class I devices are required to follow 21 CFR 820 regulations.

Liberty Management Group, a leading FDA consulting group in the United States, provides assistance with preparation and submission of 510K to FDA, US agent service for foreign facilities, medical device establishment registration and listing with FDA.

Sudha S

Regulatory Consultant

Mial : office@libertymanagement.us

www.fdahelp.us

DMF – DRUG MASTER FILES

A Drug Master File (DMF) is a document submitted by a drug manufacturer to US FDA which is used to provide confidential detailed information about facilities, procedures, or things used in the manufacturing, processing, packaging, and storing of one or more human drugs. A DMF is submitted when more companies work in partnership to manufacture a drug product, which allows the company to protect is its intellectual property rights from its partner while complying with regulatory constraints as well for disclosing of processing procedures.

DMF’s are submitted to support regulatory regulations and prove the quality, safety and effectiveness of a product for getting Investigational New Drug Application (IND), New Drug Application (NDA), Abbreviated New Drug Application(ANDA), another DMF and Export Application. However, DMF submission is NOT a substitute for an IND, NDA, ANDA or Export Application. As per FDA regulation, DMF submission is not required by law, it is solely depends to submitters discretion.

As per FDA, there are five types of DMF’s

Type I : Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
Type II : Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III : Packaging Material
Type IV : Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V : FDA Accepted Reference Information

All DMF submissions must be in the English language which should contain transmittal letter, administrative information about the submission and must include specific information about the DMF type.

All foreign DMF holders are required to appoint an U.S agent, however domestic DMF holders do not need a representative to submit it.

DMF holders should submit an annual report on the same date of their original submission. Annual report should contain all the information including name and address of DMF holder, corporate headquarters, Manufacturing/ processing facility, contact for FDA communication, agents (if any),statement of commitment and signed statement by the DMF holder assuring that the DMF is current.

Starting from May 5, 2018 onwards, new DMFs other that Type III, as well as all documents submitted to existing DMFs excluding Type III are required to submit DMF using Electronic Common Technical Document (eCTD). DMFs that are not submitted through eCTD after May 5, 2018 will be rejected, however for Type III DMFs the requirement will be effective from May 5, 2020 onwards.

Liberty Management Group Ltd, a leading FDA consulting group in the United States, provides assistance DMF eCTD submissions, US agent service, DMF closure and reactivation request submission to FDA.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us

GOOD MANUFACTURING PRACTICE (GMP)

Good Manufacturing practices is a quality system which ensure that the products are consistently produced and controlled as per the quality standards. GMP regulation provides guidance for manufacturing, testing and quality assurance to ensure that the manufactured product is safe for human consumption or use.

Implantation of GMP assures that the identity, strength, quality and purity of the products as the consumer cannot detect the safety of the product.

FDA inspects drug manufacturing facilities around the world which includes API manufacturers to check whether these companies implemented drug GMP regulations as per 21 CFR part 211. FDA will consider these drugs as adulterated if the company is not complying with GMP regulations.

Medical Device manufacturers must follow and implement quality system to ensure that their products consistently meet all medical device GMP regulations as per 21 CFR part 820. This quality system regulation is applicable to all finished device manufacturers who are planning to do commercial distribution in US. As per 21 CFR 820.3(i) a finished device is any type of device or attachment to any device that is fit for use or capable of working, whether or not it is packaged, labeled, or sterilized.

FDA has classified certain type of medical devices are exempt for GMP regulations, however it does not exempt the manufacturers of finished devices from GMP requirements.

FDA’s GMP regulation as per 21 CFR 820 is aligned with ISO 13485: 2016 to a greater extent than ISO 9001:2015 which is an internationally recognized quality system.

FDA inspects medical device manufacturing facilities to check whether their establishment is in compliance with 21 CFR 820 regulations. If the company is not in compliance with GMP regulations at the time of inspection, FDA will issue an Establishment inspection Report in observations listed on FDA form 483. It is the company’s responsibility to respond FDA 483 warning letter within 15 days and the response has to include the corrective measures taken by the company and preventive solutions taken to stop the recurrence.

Liberty Management Group, a leading FDA consulting group in the United States, provides assistance with 21 CFR 820 GMP regulations, ISO 13485 : 2016 and FDA 483 warning letters.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us

http://www.fdahelp.uss

DRUG LABELING

Drug label is a printed information which is included with any OTC drugs, prescription drugs or any dietary supplements. Drugs labels are regulated by FDA and provide information to healthcare providers and patients on safe and effective use of the product. The information on the labels must be accurate and should not be misleading

All drugs or drug products in finished package form is considered as misbranded if it does not comply with FDA labeling requirements. The labels needs to have the name and place of business of the manufacturer, packer or distributor.

All registered drug establishments which includes API manufacturer, bulk manufacturer, contract manufacturer, repackers, relabelers are required to list their products under their own labeler code, however NDC number is not required to appear on all drug labels, including the label of any prescription drugs given to a customer.

Drugs labels should contain all drug facts which includes active ingredients, purpose and uses of the drug, directions, other information, inactive ingredients, phone numbers if there is any questions or comments.

When there is an expiration date on the drug products, it should appear on the container and also in outer package. However, if it is a single dose drug product packed in individual cartons, the expiry date should be on the individual carton not on the product container.

Manufacturers, Contract manufacturers, repackers, relabelers, and private label distributors of a human prescription drugs or an over-the-counter (OTC) drugs that is regulated under the FD&C act are not required to have bar code on the products. However, if the same drug product that are sold or used in the hospitals are required to put bar code on their products.

Liberty Management Group provides assistance with drug establishment registration, drug listing and label review.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us